Sensory Integration Therapy For Children With Autism and Sensory Processing Difficulties: The Senita RCT

Journals Library
Health Technology Assessment

Volume 26 • Issue 29 • June 2022
ISSN 1366-5278
Sensory integration therapy for children

with autism and sensory processing
difficulties: the SenITA RCT
Elizabeth Randell, Melissa Wright, Sarah Milosevic, David Gillespie, Lucy Brookes-Howell,
Monica Busse-Morris, Richard Hastings, Wakunyambo Maboshe, Rhys Williams-Thomas,
Laura Mills, Renee Romeo, Nahel Yaziji, Anne Marie McKigney, Alka Ahuja,
Gemma Warren, Eleni Glarou, Sue Delport and Rachel McNamara
DOI 10.3310/TQGE0020
Sensory integration therapy for children with
autism and sensory processing difficulties:
the SenITA RCT
Elizabeth Randell ,1* Melissa Wright ,1

Sarah Milosevic ,1 David Gillespie ,1
Lucy Brookes-Howell ,1 Monica Busse-Morris ,1
Richard Hastings ,2 Wakunyambo Maboshe ,1
Rhys Williams-Thomas ,1 Laura Mills,1 Renee Romeo ,3
Nahel Yaziji ,3 Anne Marie McKigney,4 Alka Ahuja ,4
Gemma Warren, Eleni Glarou ,1,5 Sue Delport 6†
and Rachel McNamara 1†
1Centre for Trials Research, Cardiff University, Cardiff, UK
2Centre for Educational Development, Appraisal, and Research (CEDAR) University of
Warwick, Coventry, UK
3Institute of Psychiatry Psychology and Neuroscience, King’s College London,
London, UK
4Aneurin Bevan University Health Board, Newport, UK
5Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK
6School of Healthcare Sciences, Cardiff University, Cardiff, UK
*Lead and corresponding author

†Joint last/senior author
Declared competing interests of authors: David Gillespie was an associate member of the National
Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) General
Committee (2019 to September 2021) and is a member of the NIHR HTA Commissioning Committee
(September 2021 to present).
Disclaimer: This report contains transcripts of interviews conducted in the course of the research and
contains language that may offend some readers.
Published June 2022

DOI: 10.3310/TQGE0020
This report should be referenced as follows:
Randell E, Wright M, Milosevic S, Gillespie D, Brookes-Howell L, Busse-Morris M, et al. Sensory

integration therapy for children with autism and sensory processing difficulties: the SenITA RCT.
Health Technol Assess 2022;26(29). https://doi.org/10.3310/TQGE0020
Health Technology Assessment
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DOI: 10.3310/TQGE0020 Health Technology Assessment 2022 Vol. 26 No. 29
Abstract
Sensory integration therapy for children with autism and

sensory processing difficulties: the SenITA RCT
Elizabeth Randell ,1* Melissa Wright ,1 Sarah Milosevic ,1

David Gillespie ,1 Lucy Brookes-Howell ,1 Monica Busse-Morris ,1
Richard Hastings ,2 Wakunyambo Maboshe ,1 Rhys Williams-Thomas ,1
Laura Mills,1 Renee Romeo ,3 Nahel Yaziji ,3 Anne Marie McKigney,4
Alka Ahuja ,4 Gemma Warren, Eleni Glarou ,1,5 Sue Delport 6†
and Rachel McNamara 1†
1Centre for Trials Research, Cardiff University, Cardiff, UK
2Centre for Educational Development, Appraisal, and Research (CEDAR) University of Warwick,
Coventry, UK
3Institute of Psychiatry Psychology and Neuroscience, King’s College London, London, UK
4Aneurin Bevan University Health Board, Newport, UK
5Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK
6School of Healthcare Sciences, Cardiff University, Cardiff, UK
*Lead and corresponding author RandellE@cardiff.ac.uk

†Joint last/senior author
Background: Carers report unmet need for occupational therapy services addressing sensory
difficulties in autism, yet insufficient evidence exists to recommend a therapeutic approach.
Objectives: Our aim was to determine the clinical effectiveness and cost-effectiveness of sensory
integration therapy for children with autism and sensory difficulties across behavioural, functional and
quality-of-life outcomes.
Design: We carried out a parallel-group randomised controlled trial, incorporating an internal pilot and
a process evaluation. Randomisation utilised random permuted blocks.
Setting and participants: Children were recruited via services and self-referral in Wales and England.
Inclusion criteria were having an autism diagnosis, being in mainstream primary education and having
definite/probable sensory processing difficulties. Exclusion criteria were having current/previous
sensory integration therapy and current applied behaviour analysis therapy.
Intervention: The intervention was manualised sensory integration therapy delivered over 26 weeks
and the comparator was usual care.
Outcomes: The primary outcome was problem behaviours (determined using the Aberrant Behavior
Checklist), including irritability/agitation, at 6 months. Secondary outcomes were adaptive behaviour,
functioning and socialisation (using the Vineland Adaptive Behavior Scales); carer stress (measured
using the Autism Parenting Stress Index); quality of life (measured using the EuroQol-5 Dimensions
and Carer Quality of Life); functional change (according to the Canadian Occupational Performance
Measure); sensory processing (determined using the Sensory Processing Measure™ at screening and
Copyright © 2022 Randell et al. This work was produced by Randell et al. under the terms of a commissioning contract issued by the Secretary of State for Health and
Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use,
vii
distribution, reproduction and adaption in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/.
For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.
ABSTRACT
at 6 months to examine mediation effects); and cost-effectiveness (assessed using the Client Service
Receipt Inventory). Every effort was made to ensure that outcome assessors were blind to allocation.
Results: A total of 138 participants were randomised (n = 69 per group). Usual care was significantly
different from the intervention, which was delivered with good fidelity and adherence and minimal
contamination, and was associated with no adverse effects. Trial procedures and outcome measures
were acceptable. Carers and therapists reported improvement in daily functioning. The primary analysis
included 106 participants. There were no significant main effects of the intervention at 6 or 12 months.
The adjusted mean difference between groups on the Aberrant Behavior Checklist – irritability at
6 months post randomisation was 0.40 (95% confidence interval –2.33 to 3.14; p = 0.77). Subgroup
differences in irritability/agitation at 6 months were observed for sex of child (intervention × female =
6.42, 95% confidence interval 0.00 to 12.85; p = 0.050) and attention deficit hyperactivity disorder
(intervention × attention deficit hyperactivity disorder = –6.77, 95% confidence interval –13.55 to
–0.01; p = 0.050). There was an effect on carer stress at 6 months by region (intervention × South
England = 7.01, 95% confidence interval 0.45 to 13.56; p = 0.04) and other neurodevelopmental/
genetic conditions (intervention × neurodevelopmental/genetic condition = –9.53, 95% confidence
interval –18.08 to –0.98; p = 0.030). Carer-rated goal performance and satisfaction increased
across sessions (p < 0.001), with a mean change of 2.75 (95% confidence interval 2.14 to 3.37) for
performance and a mean change of 3.34 (95% confidence interval 2.63 to 4.40) for satisfaction.
Health economic evaluation suggests that sensory integration therapy is not cost-effective compared
with usual care alone.
Limitations: Limitations included variability of the intervention setting (i.e. NHS vs. private), delay for
some receiving therapy, an error in administration of Vineland Adaptive Behavior Scales and no
measurement of comparator arm goal performance.
Conclusions: The intervention did not demonstrate clinical benefit above standard care. Subgroup
effects are hypothesis-generating only. The intervention is likely to be effective for individualised
performance goals, although it is unclear whether effects were in addition to standard care or
were maintained.
Future work: Further investigation of subgroup effects is needed.
Trial registration: This trial is registered as ISRCTN14716440.
Funding: This project was funded by the National Institute for Health and Care Research (NIHR)
Health Technology Assessment programme and will be published in full in Health Technology
Assessment; Vol. 26, No. 29. See the NIHR Journals Library website for further project information.
viii

Contents
List of tables xv
List of figures xvii
List of abbreviations xix
Plain English summary xxi
Scientific summary xxiii
Chapter 1 Introduction 1
Prevalence and impact of autism 1
Prevalence and impact of sensory processing difficulties in autism 1
Therapeutic approaches to treating sensory difficulties 1
Sensory-based interventions 2
Sensory integration therapy 3
Current evidence gaps and research priorities 3
The SenITA trial 4
Chapter 2 Usual care for children with autism and sensory processing difficulties 5
Aim 5
Methods 5
Recruitment and sampling 5
Carer participants 5
Occupational therapist participants 5
Data collection 6
Ethics approval and data management 7
Analyses 7
Online questionnaires 7
Focus groups and interviews 7
Results 7
Carers’ views of usual occupational therapy for children with autism and sensory
processing difficulties 7
Nature of reported difficulties 8
Carers’ views on contact with services 9
Carers’ views on occupational therapy assessments and treatment 10
Occupational therapist views of usual care 13
Questionnaire responses by occupational therapists 13
Focus groups and interviews with occupational therapists 13
Discussion 18
Representativeness of views 18
Theoretical approaches to intervention 18
Accessing services and the referral process 18
Assessment process 19
Intervention 19
Summary 20
ix
CONTENTS
Chapter 3 Methods 21
Design 21
Objectives 21
Primary objective 21
Secondary objectives 21
Site selection 22
Participants 23
Inclusion criteria 23
Exclusion criteria 23
Recruitment process 23
Informed consent 23
Risk assessment 24
Intervention 24
Sensory integration therapy 24
Comparator 24
Outcomes 24
Screening and baseline measures 24
Primary outcome measure 25
Secondary outcome measures 25
Randomisation 26
Sample size 26
Procedures 27
Trial oversight and patient and public involvement 27
Staff training 27
Sensory integration therapy sessions 27
Assessment time points 27
Data collection 28
Screening and baseline visit 28
Follow-up data collection 29
Intervention data collection 31
Qualitative data collection 33
Data management 33
Safety reporting 33
Analyses 33
Analysis population 33
Main analysis 34
Subgroup analysis 34
Sensitivity and exploratory analysis 34
Health economic analysis 35
Qualitative analysis 35
Process evaluation 35
Chapter 4 Internal pilot evaluation 37

Aims and objectives 37
Usual care 37
Recruitment of participants 37
Retention of participants at 6 months post randomisation 37
Contamination (i.e. the extent to which participants allocated to the control arm
received treatment/therapy similar to that in the intervention arm) 37
Adherence (i.e. receipt of intervention by participants allocated to the intervention arm) 37
Fidelity of intervention delivery 37
Sample size assumptions 37
Adverse effects 38

Outcomes 38
Primary outcome 38
Secondary outcomes 38
Progression criteria 39
Methods 39
Results: primary outcomes 39
Usual care 40
Recruitment 41
Retention 41
Results: secondary outcomes 42
Contamination 42
Adherence/acceptability 42
Fidelity 42
Other sample size assumptions 42
Adverse effects 42
Summary of progress against progression criteria 42
Proposed modifications to design 43
Sample size implications 43
Discussion 43
Chapter 5 Intervention 45
Overview: sensory integration therapy 45
Therapists 45
Fidelity assessment tool 46
Fidelity principles 46
Initial assessment 47
Initial greeting and scene-setting 47
Clinical observations 47
The Sensory Integration and Praxis Tests 47
Occupational profile 48
Sensory Processing Measure 48
Canadian Occupational Performance Measure 48
Interpretation of assessment 48
Hypothesis development 49
Goal development 49
Summary of strengths, participation challenges and goals 49
Mentoring 49
Intervention session content 50
Session 1 50
Intervention sessions 2–20 51
Intervention sessions 21–23 52
Intervention session 24 52
Chapter 6 Quantitative results 53

Recruitment and participant flow 53
Baseline characteristics 54
Intervention receipt and fidelity 57
Initiation of sensory integration therapy 57
Implementation of sensory integration therapy 57
Secondary analysis of primary outcome 60
xi
CONTENTS
Secondary outcomes 64
Behavioural measures 64
Adaptive behaviour measures 65
Parenting stress 66
Health utility and quality of life 66
Teacher-assessed Aberrant Behavior Checklist – irritability 66
Canadian Occupational Performance Measure 67
Subgroup analysis 67
Subgroup effects for the Aberrant Behavior Checklist – irritability 67
Subgroup effects for the Autism Parenting Stress Index 68
Additional sensitivity analyses 70
Accounting for intervention receipt 70
Impact of the COVID-19 pandemic 70
Adverse events 72
Chapter 7 Health economics 73

Introduction and methods 73
Identification of resources 73
Measure of resources 74
Intervention delivery 74
Usual care 74
NHS/Personal Social Services 74
Productivity losses 74
Valuation of resources 74
Sensory integration therapy sessions 74
NHS/Personal Social Services 74
Productivity costs 75
Data analysis 77
Service and support use 77
Analysis of costs 77
Cost-effectiveness analysis 77
Sensitivity analyses 78
Results 78
Data completeness 78
Resource use 78
Total costs 78
NHS/Personal Social Services perspective 78
Societal perspective 82
Outcomes 84
Cost-effectiveness: 6-month follow-up 84
Cost-effectiveness: 12-month follow-up 87
Impact of COVID-19 88
Summary 90
Chapter 8 Process evaluation: recruitment, retention, fidelity and safety 93

Methods and materials 93
Research design 93
Quantitative data collection 93
Recruitment of participants and therapists 93
Retention 93
Fidelity of intervention delivery 95
xii

Adherence 95
Adverse effects 95
Contamination 96
Qualitative data collection 96
Data analysis 96
Quantitative analysis 96
Qualitative analysis 96
Results 97
Recruitment of participants and therapists 97
Retention 99
Fidelity of the intervention 99
Acceptability 101
Adherence 108
Adverse events 108
Contamination 108
Contextual factors 108
Conclusions 110
Chapter 9 Carer experiences of usual care, and carer and therapist experiences of
the intervention 111
Methods 111
Overview 111
Participants 111
Sampling and recruitment 112
Study materials 112
Data collection 112
Analysis 112
Results: part 1 – support experiences of families 113
Support provision 114
Usefulness of support 115
Unmet support needs 116
Results: part 2 – perceived impact of sensory integration therapy 118
Effect on the child 118
Effect on family and school life 120
Limitations 121
Summary 123
Chapter 10 Discussion 125

Overview 125
Summary and interpretation of findings 125
Recruitment and retention 125
Baseline characteristics and reach 125
Usual care and contamination 125
Fidelity and intervention receipt 126
Acceptability 126
Behavioural outcomes 126
Parenting stress, quality of life and health utility 127
Functional outcomes: occupational performance 127
Health economic analysis 127
Summary 127
xiii
CONTENTS
Strengths and limitations 128

Strengths 128
Limitations 128
Conclusions and implications 129
Acknowledgements 131
References 133
xiv

List of tables
TABLE 1 Respondents by geographic region/university health board 9
TABLE 2 Contact with services (n = 159) 9
TABLE 3 Interventions received by families (n = 159) 11
TABLE 4 Therapist advice given to carers 16
TABLE 5 Interventions for children/families 16
TABLE 6 Schedule of enrolment, interventions and assessments 28
TABLE 7 Contents of the research assistant data collection manual 29
TABLE 8 Contents of the SenITA intervention therapist data collection manual 31
TABLE 9 Criteria for progression from internal pilot to full trial 39
TABLE 10 Respondents by geographical region (pilot evaluation phase) 40
TABLE 11 Recruitment figures against progression criteria 41
TABLE 12 Retention figures against progression criteria 42
TABLE 13 Summary of internal pilot findings 43
TABLE 14 Required sample size accounting for correlation between baseline and
6-month ABC-I scores 44
TABLE 15 Levels of adaptive responses 51
TABLE 16 Baseline characteristics 54
TABLE 17 Summary of baseline ADOS scores by trial arm 56
TABLE 18 Descriptive statistics of SIT implementation for six participants 59
TABLE 19 Baseline scores by arm 60
TABLE 20 Outcome scores at 6 and 12 months 61
TABLE 21 Regression analysis comparing the intervention arm with the control arm,
adjusting for baseline score, sex of child, SPM category and region: 6 months 65
TABLE 22 Regression analysis comparing the intervention group with the control
group, adjusting for baseline score, sex of child, SPM category and region: 12 months 66
TABLE 23 Comparison of COPM scores between session 1 and session 24 67
xv
LIST OF TABLES
TABLE 24 Subgroup analyses for ABC-I at 6 months 68
TABLE 25 Subgroup analyses for Carer Stress at 6-months 69
TABLE 26 Sensitivity analysis of the primary outcome accounting for intervention receipt 71
TABLE 27 Comparison of primary analysis and primary analysis in those with primary
outcome data available prior to the COVID-19 pandemic (pre 23 March 2020) 71
TABLE 28 Primary outcome analysis under different scenarios 72
TABLE 29 Unit cost (2020/21) of SIT sessions 75
TABLE 30 Unit costs 75
TABLE 31 Service use (unit) at baseline (for previous 6 months) 79
TABLE 32 Service use (unit) at 6-month follow-up (for previous 6 months) 80
TABLE 33 Service use (unit) at 12-month follow-up (for previous 6 months) 81
TABLE 34 Total costs (£) at baseline by arm (for previous 6 months) 82
TABLE 35 Total costs (£) at 6-month follow-up by arm (for previous 6 months) 83
TABLE 36 Total costs (£) at 12-month follow-up by arm (for previous 6 months) 84
TABLE 37 Differences in incremental costs, effect and cost-effectiveness at

6 and 12 months 85
TABLE 38 Total costs (£) at 6- and 12-month follow-up by arm 89
TABLE 39 Differences in incremental costs, effect and cost-effectiveness at

6 and 12 months 90
TABLE 40 Summary of process evaluation data sources and objectives 94
TABLE 41 Calculated process fidelity scoring 97
TABLE 42 Number of ratings per session 100
TABLE 43 Breakdown of scores for therapist 7 100
TABLE 44 Breakdown of scores for therapist 8 101
TABLE 45 Carer interviews: participant characteristics 111
TABLE 46 Themes and subthemes: support experiences of families 113
TABLE 47 Themes and subthemes: perceived impact of SIT 118
xvi

List of figures
FIGURE 1 Routes of support described by occupational therapists 8
FIGURE 2 The SenITA trial participant flow diagram 22
FIGURE 3 Flow diagram of data collection procedures 30
FIGURE 4 Flow diagram for therapist data collection 32
FIGURE 5 A CONSORT (Consolidated Standards of Reporting Trials) flow diagram 53
FIGURE 6 Time from randomisation to initiation of SIT in days (for the

61 participants allocated to and initiating SIT) 57
FIGURE 7 Panel plot of session attendance for six different participants 58
FIGURE 8 ABC-I scores at baseline and 6 months, by site 63
FIGURE 9 Carer- and teacher-assessed ABC-I 67
FIGURE 10 Distribution of ABC-I scores at 6 months in those who did and did not
initiate SIT 70
FIGURE 11 Distribution of ABC-I scores at 6 months in those who did and did not
receive at least 13 SIT sessions during the intensive phase 70
FIGURE 12 Box plot of ABC-I scores at 6 months for those who received differing
levels of SIT 71
FIGURE 13 Box plots of ABC-I scores at 6 months by arm and by time period 72
FIGURE 14 Bootstrapped mean differences in health and social care costs and
effects (6-month ABC-I total score): cost-effectiveness plane – SIT vs. usual care
(NHS/PSS perspective) 85
FIGURE 15 Bootstrapped mean differences in societal costs and effects (6-month

ABC-I total score): cost-effectiveness plane – SIT vs. usual care (societal perspective) 86
FIGURE 16 Health-care and social care costs and effects (6-month ABC-I scores): CEAC 86
FIGURE 17 Societal costs and effects (6-month ABC-I scores): CEAC 87
FIGURE 18 Bootstrapped mean differences in health-care and social care costs and
effects (12-month ABC-I total score): cost-effectiveness plane – SIT vs. usual care
FIGURE 19 Bootstrapped mean differences in societal costs and effects (ABC-I total
score: 12-month complete-case analysis): cost-effectiveness plane – SIT vs. usual care
xvii
LIST OF FIGURES
FIGURE 20 NHS/PSS perspective (12-month ABC-I scores): CEAC 88
FIGURE 21 Societal perspective (12-month ABC-I scores): CEAC 89
FIGURE 22 Imputed data set: NHS/PSS perspective (6-month ABC-I scores) – CEAC 90
FIGURE 23 Imputed data set: societal perspective (6-month ABC-I scores) – CEAC 91
FIGURE 24 Imputed data set: NHS/PSS perspective (12-month ABC-I scores) – CEAC 91
FIGURE 25 Imputed data set: societal perspective (12-month ABC-I scores) – CEAC 91
FIGURE 26 How parents heard about the trial 98
xviii

List of abbreviations
ABC Aberrant Behavior Checklist ICC intracluster correlation
coefficient
ABC-I Aberrant Behavior Checklist –
irritability ICER incremental cost-effectiveness
ratio
ADHD attention deficit hyperactivity
disorder ID intellectual disability
ADOS Autism Diagnostic Observation IQR interquartile range
Schedule
IT information technology
AE adverse event
NAS National Autistic Society
APSI Autism Parenting Stress Index
NICE National Institute for Health
ASD autism spectrum disorder and Care Excellence
ASI Ayres Sensory Integration OT occupational therapy
CAMHS Child and Adolescent Mental PI principal investigator
Health Services
PIS participant information sheet
CarerQol Carer Quality of Life
PSS Personal Social Services
CarerQol-7D Carer Quality of Life –
RCT randomised controlled trial
7 Dimensions
SAE serious adverse event
CarerQol-VAS Carer Quality of Life – visual
analogue scale SD standard deviation
CEAC cost-effectiveness acceptability SenITA SENsory Integration Therapy

curve for sensory processing
difficulties in children with
CI confidence interval
Autism spectrum disorder
COPM Canadian Occupational
SIPT Sensory Integration and
Performance Measure
Praxis Test
CSRI Client Service Receipt
SIT sensory integration therapy
Inventory
SLT speech and language therapy
EQ-5D EuroQol-5 Dimensions
SPD sensory processing difficulty
EQ-5D-5L EuroQol-5 Dimensions,
five-level version SPM Sensory Processing Measure
EQ-VAS EuroQol visual analogue scale SQL Structured Query Language
GAS Goal Attainment Scale VABS Vineland Adaptive Behavior

Scales
GCP good clinical practice
VABS II Vineland Adaptive Behavior
GP general practitioner
Scales, second edition
xix
Plain English summary

C hildren with autism often experience problems with processing sensory information (e.g. noise,
touch, movement, taste and sight), and this can lead to problems in daily life. This study was
designed to see if sensory integration therapy can help children with these difficulties. Sensory
integration therapy is a type of face-to-face play-based treatment that is delivered by occupational
therapists. We compared sensory integration therapy with the type of treatment normally offered to
children with autism (i.e. ‘usual care’). We recruited children and their carers from Wales and England.
Children could take part in the study if they had an autism diagnosis, had sensory processing difficulties
and were in mainstream primary education. The children taking part in the study were randomly split
into two groups. Sixty-nine children were given sensory integration therapy and 69 children carried
on with their usual care. The sensory integration therapy involved 24 face-to-face sessions in an
occupational therapy clinic, followed by two telephone calls with the carer. The sensory integration
therapy lasted for 26 weeks. We collected information on the type of care being given to children in
the usual-care group. Carers of each child were asked questions about their child’s behaviour 6 and
12 months after starting the study. Some carers also completed an interview to talk about what it was
like taking part in the study.
Therapists delivered the sensory integration therapy well. Carers and therapists said that they saw
some improvements. However, sensory integration therapy was not significantly better than the usual
care and is a more expensive option. We cannot say that sensory integration therapy is helpful for all
children with autism and different sensory processing difficulties; however, it might be helpful for some
children to focus on specific problems. Future work could focus on which children and problems it
would help the most.
xxi
Scientific summary
Background
Approximately 1–2% of children have a diagnosis of autism in the UK, of whom ≥ 90% also experience
at least moderate sensory processing difficulty (SPD), which can have an impact on their daily life and
well-being. Addressing SPDs using specific interventions, which are typically delivered by occupational
therapists, could lead to improvements across behavioural, social and educational domains. The National
Institute for Health and Care Excellence (NICE) guidelines on the management of and support for
children and young people with autism highlight parental perceptions of unmet need for occupational
therapy (OT) input to address sensory and functional difficulties. However, despite unmet need, there
is insufficient evidence to recommend any one therapeutic approach. NICE has recommended further
research to establish whether or not sensory integration therapy (SIT) improves SPDs in children with
autism across a range of contexts. Several systematic reviews have identified only two randomised
studies of SIT. Both reported good fidelity of delivery; however, the intervention protocols were variable
in terms of dose and delivery period, and both studies are limited by small convenience samples, poorly
described comparators and only short-term follow-up. The SenITA (SENsory Integration Therapy for
sensory processing difficulties in children with Autism spectrum disorder) randomised controlled trial
(RCT) tested the clinical effectiveness and cost-effectiveness of SIT, which is a manualised play-based
intervention delivered by occupational therapists to address specific sensory difficulties. SIT was
compared with usual care for children aged 4–11 years with autism and SPDs. Outcomes, which were
assessed at 6 and 12 months, included behavioural, functional and socialisation outcomes, quality of life,
well-being and cost-effectiveness.
Objectives
l To describe current usual care in trial regions and clearly differentiate this from the
trial intervention.
l To evaluate the clinical effectiveness of manualised SIT for SPDs in young children with autism in
terms of impact on behavioural problems and adaptive skills, socialisation, carer stress, quality of life
and cost-effectiveness.
l To explore recruitment, retention, fidelity of delivery, adherence, acceptability, adverse effects and
contamination in a process evaluation conducted alongside the main trial.
Methods
Design
The SenITA trial was a two-arm individual RCT of SIT for children with autism and SPDs.
Setting and population

Children with autism and SPDs were recruited from child and adolescent mental health and paediatric
services, schools and social services and via self-referral. Therapy was delivered in clinics meeting
manualised fidelity criteria. Inclusion criteria were as follows: diagnosis of autism spectrum disorder or
a related condition (e.g. social communication disorder), in and likely to remain in mainstream primary
education for the duration of the trial (and aged 4–11 years), definite/probable SPDs and carer consent/
child assent. Exclusion criteria were as follows: receipt of current/previous SIT and receipt of current
applied behaviour analysis therapy.
xxiii
SCIENTIFIC SUMMARY
Intervention and comparator

The intervention comprised Ayres Sensory Integration® therapy delivered in 26 1-hour sessions over
26 weeks [i.e. two sessions per week for 10 weeks (intensive phase), followed by two sessions per
month for 2 months and then one telephone session per month for 2 months (tailoring phase)].
The comparator was usual care, which was defined as awaiting services or receiving sensory-based
intervention not meeting fidelity criteria for sensory integration. Pre-trial focus groups and interviews
carried out with parents/carers and therapists allowed us to define usual care in trial regions and,
to some extent, across the UK more broadly.
Sample size and randomisation

A total of 138 participants were randomised in a 1 : 1 ratio based on 90% power, a 5% significance
level and a moderate standardised effect size of 0.5 (inflated by 20% for dropout). Online
randomisation utilised random permuted blocks stratified by region and severity of SPD.
Costs and outcomes

Sensory processing difficulties were assessed at screening and at 6 months. An Autism Diagnostic
Observation Schedule was carried out at baseline to characterise the sample in terms of autism
symptoms only and not for diagnostic purposes. Outcomes were measured at 6 and 12 months post
randomisation. The primary outcome was irritability/agitation (as measured by the corresponding
Aberrant Behavior Checklist subscale), indicative of challenging behaviour, at 6 months. Secondary
outcomes included other problem behaviours, adaptive behaviours and functioning, socialisation,
carer stress and quality of life.
Statistical analyses
The main analyses were modified intention to treat, with those participants providing outcome data
included. A full intention-to-treat analysis comprised all participants in the group to which they were
randomised, with missing outcome data imputed using multiple imputation. This analysis set served
as a sensitivity analysis to the primary outcome. Finally, a complier-average causal effect population
comprised participants with outcome data in the group to which they were randomised, accounting
for those participants who received the intervention as intended. This analysis set also served as a
sensitivity analysis to the primary outcome. Primary outcome analysis compared trial arms by fitting
linear regression to irritability/agitation scores 6 months post randomisation, adjusting for baseline
scores, recruitment region, severity of sensory difficulty and sex of the child. Findings are reported as
adjusted mean differences with associated 95% confidence intervals (CIs) and p-values. Most secondary
outcomes were analysed similarly.
We explored differential intervention effects on the primary outcome by age, severity of SPD and
comorbid conditions [i.e. attention deficit hyperactivity disorder (ADHD), intellectual disability (ID)
and other neurodevelopmental/genetic condition], site, region and sex of the child. Our primary model
was extended by including subgroup × trial arm interaction terms. Subgroup effects were also explored
for carer stress scores 6 months post randomisation. We used multiple imputation to investigate
the potential influence of missing data on the primary outcome. Sensitivity analyses adjusted for
intervention receipt, impact of the COVID-19 pandemic and the correlated nature of repeated
observations within individuals. Models adjusted for baseline measures and variables balanced
at randomisation. We planned to conduct mediation analyses to explore whether or not any
intervention effects at 12 months were mediated through an effect on sensory sensitivities post
intervention. Agreement between parent- and teacher-reported Aberrant Behavior Checklist –
irritability (ABC-I) scores was assessed using a Bland–Altman plot. Performance on carer-reported
goals was compared between sessions 1 and 24 using paired t-tests for participants allocated to the
intervention only.
xxiv

Cost-effectiveness
A cost-effectiveness evaluation assessed intervention, NHS, social and education service costs, as well
as carer costs. The main cost-effectiveness measure was the incremental cost per point improvement in
irritability/agitation at the primary outcome time point.
Internal pilot and process evaluation

An internal pilot with progression criteria assessed recruitment, retention and whether or not usual care
differed from expected provision. A process evaluation examined recruitment, retention, fidelity of delivery,
adherence, acceptability, adverse effects and contamination. Therapist and carer interviews conducted as
part of the process evaluation explored barriers to and facilitators of participation, adherence, therapeutic
relationship, mechanisms of change, sensory processing deficit, engagement in activities and contamination.
Interview and focus group data were double coded and analysed thematically.
Results
Internal pilot and process evaluation

Targets for recruitment, retention and other key parameters used to estimate sample size were met,
maintaining 90% power at the primary analysis time point. Usual care was significantly different from
the intervention offered as part of the trial, was delivered with good fidelity and adherence, and there
was no evidence of significant contamination in the comparator arm or that participants allocated to
SIT received meaningful intervention via other routes. No adverse effects were reported.
Trial procedures and outcome measures were acceptable to carers, and therapists generally found
involvement in the trial to be a positive experience. Carers in the intervention arm reported high
levels of satisfaction and benefit of SIT, although no statistically significant change in carer stress was
observed. Both carers and therapists tended to report improvements in well-being and daily functioning,
although there is no evidence to suggest that these effects were maintained following completion of
therapy. Therapists’ experience of delivering sensory integration was generally positive, and most felt
that it could offer benefit to some children, depending on their need.
Clinical effectiveness
There were, however, no statistically significant effects of the intervention on the primary outcome
of irritability/agitation at 6 months {mean score: usual care 18.8 [standard deviation (SD) 10.48];
intervention 18.5 (SD 9.33)}. Adjusted mean difference between groups on the ABC-I at 6 months
post randomisation was 0.40 (95% CI –2.33 to 3.14; p = 0.77). The correlation between baseline
and 6-month scores was 0.698 (95% CI 0.585 to 0.784). Teacher-rated irritability/agitation scores at
6 months, where available, were typically lower than carer ratings [i.e. the mean difference between
carer-rated and teacher-rated scores at 6 months was 10.28 (SD 14.48), with a 95% limit of agreement
of –18.12 to 38.68]. There was strong evidence of a difference between the two measures (p < 0.001),
indicating that, on average, carer ratings were higher. Conclusions drawn from primary analyses were
unaffected by sensitivity analyses accounting for missing data, intervention receipt (i.e. dose) or the
COVID-19 pandemic. No evidence of meaningful intervention effects was found at 6 or 12 months
across behavioural, adaptive functioning, socialisation, carer stress, health utility or quality-of-life
measures. Carer-rated goal performance and satisfaction data were available for a subset of participants
allocated to receive the intervention. There was strong evidence of an increase in scores on both
measures between session 1 and session 24 [i.e. a mean change in score of 2.75 (95% CI 2.14 to 3.37)
for carer-rated performance and of 3.34 (95% CI 2.63 to 4.40) for satisfaction; p < 0.001].
There was a differential effect of the intervention on irritability/agitation at 6 months by region (intervention
arm × South England = 9.77, 95% CI 4.04 to 15.49; p = 0.001). The results also indicate a differential
effect of the intervention on the primary outcome at 6 months by sex of child (intervention × female = 6.42,
xxv
SCIENTIFIC SUMMARY
95% CI 0.00 to 12.85; p = 0.050) and those with ADHD (intervention × ADHD = –6.77, 95% CI –13.55
to –0.01; p = 0.050). Similarly, there was a differential effect of the intervention on carer stress at
6 months by region (intervention arm × South England = 7.01, 95% CI 0.45 to 13.56; p = 0.04) and presence
of other neurodevelopmental or genetic conditions (intervention × neurodevelopmental/genetic condition
present = –9.53, 95% CI –18.08 to –0.98; p = 0.030). No differential effects were observed at 6 months
for severity of SPD, general comorbidity, ID or other specific neurodevelopmental or genetic condition.
Cost-effectiveness
The delivery of SIT incurred significant additional costs. When intervention costs were not included in
total NHS/Personal Social Services (PSS) costs, NHS/PSS costs of care for usual care-only participants
were significantly higher than NHS/PSS costs for SIT participants. Economic evidence suggests, however,
that SIT has a low probability of being a cost-effective option compared with usual care.
Conclusions
The SenITA trial was a robust evaluation of the clinical effectiveness and cost-effectiveness of sensory
integration for behavioural, functional and quality-of-life outcomes. Targets for recruitment, retention
and other key parameters used to estimate sample size were met, and usual care for the trial
population was described in detail and found to be significantly different from the sensory integration
intervention offered as part of the trial. SIT was delivered with fidelity and adherence was generally
high, with no evidence of significant contamination. No adverse effects were reported. The population
recruited were probably representative of children within autism services, although girls and minority
ethnic boys are likely to be under-represented in both the current study and the wider population of
children diagnosed with autism. Acceptability was high among carers and therapists, in terms of both
study participation and intervention receipt and delivery, and therapists generally felt that SIT could
offer benefit to some children, depending on their needs.
No main intervention effects were observed, and sensitivity analyses did not alter the interpretation
of results. Subgroup analyses suggest that SIT may work better for boys and those with a comorbid
diagnosis of ADHD. However, these subgroup analyses were exploratory analyses and, although the
results were statistically significant and indicative of clinical importance, were not powered to detect
effects. Therefore, the results may be reflective of multiple testing and need to be confirmed in a
subsequent study. Carer-rated goal performance and satisfaction did increase significantly with exposure
to the intervention, and carers and therapists generally reported improvements in well-being and
functioning following intervention receipt. However, there is no evidence to suggest any improvements
were maintained in the longer term, that is, following completion of therapy. Economic evaluation also
suggests that SIT is not cost-effective compared with usual care.
Strengths and limitations

A key strength was that the trial was powered to determine the clinical effectiveness and cost-
effectiveness of SIT for children with autism and SPDs. The intervention was delivered with good
fidelity and adherence and was acceptable to families and therapists, and no adverse effects were
reported. The inclusion of longer-term outcome assessment is also a strength, as previous studies have
assessed outcomes post intervention only. The SenITA trial has also provided a detailed description
of usual care for children with autism and SPDs and has highlighted the gap between available services
and the types of intervention and support that are most valued by carers.
There are a number of limitations of the current trial, however, including variability of intervention
provision across regions (i.e. NHS delivery in Wales and delivery by private practitioners in England),
underestimation of intervention delivery costs (i.e. time allowed for initial assessment and clinical
reasoning) and delay for some participants allocated to intervention in receiving therapy (although
sensitivity analyses do not suggest any differential effect). In addition, there was an error in
xxvi

administration of the Vineland Adaptive Behavior Scales, creating a ceiling effect, although, similarly,
given the pattern of results across other outcomes, it is not likely that this would have altered the
interpretation of the results. Interpretation of the positive effect of therapy on carer-reported goal
performance is also limited in that it was not possible to measure this outcome in the control arm,
as families were not generally under the care of OT services.
Taken together, the results suggest that SIT did not demonstrate clinical benefit across a range of
outcomes (i.e. behavioural, functional, social, quality of life and well-being) over and above standard
care for young children with autism and SPDs. Although statistically significant intervention effects
were observed for some subgroups (i.e. boys and children with comorbid ADHD), these findings should
be considered as hypothesis-generating only and require further confirmation. It is also likely that
SIT is effective for individualised (carer-reported) performance goals, although it was not possible to
compare goals set in the intervention arm with standard care in the current trial, and it is not clear
whether or not perceived improvements are maintained in the longer term.
Trial registration
This trial is registered as ISRCTN14716440.
Funding
This project was funded by the National Institute for Health and Care Research (NIHR) Health
Technology Assessment programme and will be published in full in Health Technology Assessment;
Vol. 26, No. 29. See the NIHR Journals Library website for further project information.
xxvii
Chapter 1 Introduction
Prevalence and impact of autism
The prevalence of autism in UK primary school-aged children is approximately 1–2%1 and the effects of
autism are well documented, including increased incidence of mental health disorders, most commonly
anxiety. Approximately 40–90% of children with a diagnosis of autism spectrum disorder (ASD) also
meet the criteria for at least one anxiety disorder.2,3 The impacts on family life are significant. Parents
report higher levels of stress4 and loss of earnings,5 and the lifetime cost to the UK economy of supporting
an autistic individual is estimated at £0.92–1.5M.5 Relationship difficulties, particularly at school, are
also commonly reported. Children with autism are significantly more likely than neurotypical peers to
experience bullying6 and tend to have fewer friendships.7
Prevalence and impact of sensory processing difficulties in autism
Difficulty in processing sensory information and, in particular, extreme sensitivity or insensitivity to

sensory input from the environment is common in autism,8 with prevalence estimates of 90–95%.9–11
Such difficulties may exacerbate social communication deficits and increase the frequency of restrictive
and repetitive behaviour, and may occur because of impaired regulation of central nervous system
arousal.12 Hyper-reactivity, reflecting the autonomic nervous system ‘fight or flight’ response, may
result in behaviours such as aggression, hypervigilance or withdrawal (owing to poor tolerance of noise,
touch, smell or movement), or additional ‘safe space’ needs. Hyporeactivity, in contrast, is characterised
by reduced awareness of sensory stimuli within the environment.13 Impaired sensory processing may
also result in poor motor control, affecting participation in daily life.
Sensory modulation difficulties (i.e. difficulty recognising and/or integrating sensory information) in
children with autism probably pose substantial burden to children and families, limiting participation in
leisure activities,14,15 and are linked to problems with activities of daily living, such as eating, sleeping,
dressing, toileting and personal hygiene.16 Such difficulties represent a long-term challenge for health
services in terms of treating potential consequences, such as behaviours that challenge and mental
health disorders. Awareness and management of sensory difficulties in mainstream educational settings
is also likely to affect peer relationships and educational outcomes. The potential pathway of effect is
unconfirmed [i.e. the mechanism(s) by which sensory difficulties affect key outcomes], but it is plausible
that reducing sensory processing difficulties (SPDs) could lead to improvements across behavioural,
social and educational domains.
Therapeutic approaches to treating sensory difficulties
The National Institute for Health and Care Excellence (NICE) guidelines on the management and
support of children and young people with autism17 highlight parental perceptions of unmet need for
occupational therapy (OT) input to address sensory and functional difficulties as part of the wider
supportive network spanning education, health and social care. However, despite this clear unmet
need, there is insufficient evidence to recommend any single therapeutic approach for SPDs. The
NICE Guideline Development Group recommended further research to establish whether or not
sensory integration therapy (SIT) improves SPDs in children and young people with autism across a
range of contexts.
1
INTRODUCTION
The primary goal of OT intervention is to enable participation in activities of everyday life18 by

supporting people to engage in the occupations they need, want or are expected to do,19 considering
their engagement and performance within relevant environments.20 OT intervention for children with
autism and SPDs is set within this context. There is a range of approaches used to achieve occupational
goals, some of which focus on addressing underlying impairment (i.e. a ‘bottom-up’ approach21) and
others on adapting the activity or environment for the individual to achieve these goals (i.e. a ‘top-down’
approach22). Both approaches aim to improve occupational engagement, participation and performance,
with the distinction that ‘bottom-up’ approaches address underlying SPDs to improve activities of
daily living, whereas ‘top-down’ approaches focus on environmental support to accommodate sensory
difficulties. These ‘top-down’ approaches include the use of sensory strategies that are not intended
to address underlying neurological factors but focus, instead, on adapting the task or environment to
accommodate the individual’s sensory needs, or on more targeted support (e.g. helping the child to use
self-regulation to manage their sensory needs). ‘Bottom-up’ treatment approaches include Ayres Sensory
Integration® (ASI) therapy, which is a play-based intervention providing sensory–motor engagement in
meaningful activities while adhering to fidelity principles,23 and sensory-based interventions, which are
adult-directed application of sensory input to effect change in behaviour linked to sensory modulation
difficulties. These interventions are intended to influence how the child integrates sensory information
to facilitate the development of adaptive responses in everyday life.
Sensory-based interventions are usually adult-directed sensory stimulation strategies applied to

the child (i.e. without their active engagement) or made available to the child for regulation of their
reactivity within the home or school environment. Sensory-based interventions typically focus on a
single or narrow range of sensory modalities or techniques (e.g. use of weighted blankets, pressure
vests, brushing and sitting on a ball). Adaptations to family routines and the environment may be
suggested. Although some studies report positive effects of this approach, for example by coaching
children and families to adapt routines and activities,24 effectiveness evidence for functional performance
is limited, particularly if strategies are not individualised to the child.13 However, sensory-based
interventions, as well as sensory strategies and environmental adaptations, are currently reported by
many professionals and carers as the most common form of ‘usual care’ in a UK setting. Treatment that
meets the fidelity requirements for SIT (in terms of content and dose) is not often reported within the
UK context, although evidence suggests that parents’/carers’ preference is for this more intensive type
of intervention (see Chapter 2).
Sensory-based interventions
Case-Smith et al.13 systematically reviewed evidence (from 2000 to 2012) of sensory-based interventions
and SIT for children with autism and SPDs. Nineteen studies were included in the review, including
14 studies of sensory-based interventions. Sensory-based interventions were defined as those that were
based on individual assessment of the child’s sensory needs and functional performance, included explicit
self-regulation goals and associated behavioural outcomes, and required the child to actively participate.
Few positive effects were reported for studies evaluating sensory-based interventions.13 Thirteen of
14 studies eligible for review were multiple baseline single-case evaluations of weighted vests, therapy
balls and different types of vestibular stimulation (e.g. swinging and bouncing). One study25 found a
positive effect for weighted vests on attention. There was limited evidence to support the use of therapy
balls to increase sitting behaviours.26,27 A further study28 demonstrated a positive effect of a sensory diet
(e.g. brushing, swinging and jumping) on self-regulation behaviours. Only one study29 was a randomised
controlled trial (RCT) (n = 30) of a ‘sensory diet’ protocol (i.e. exposure to a variety of different sensory
experiences and practice of specific activities), which found positive effects in terms of a reduction in
sensory difficulties overall, but did not assess fidelity or blind outcome assessors. The intervention also
included several behavioural techniques (e.g. modelling, prompting and cueing) and, therefore, it is not
possible to isolate the effects of sensory-based approaches.13 In summary, evidence to support the use of
sensory-based interventions is limited in scope, methodology and generalisability.

Sensory integration therapy
Sensory integration therapy is a clinic-based approach that focuses on the therapist–child relationship
and uses play-based sensory motor activities to address sensory–motor factors specific to the child to
improve their ability to process and integrate sensation.30 To distinguish SIT from other sensory-based
interventions, a set of fidelity principles to guide delivery was developed and registered as ASI.31,32
A fidelity measure has also been developed for use in research.23 These principles ensure that underlying
sensory–motor difficulties affecting activities of daily living are addressed through presenting a range of
sensory opportunities and active engagement of the child in sensory–motor play at the ‘just-right’ level
of challenge, within the context of a collaborative therapist–child relationship. Studies meeting ASI
fidelity principles have been shown to lead to improvement in client-oriented goals,33,34 but research
is limited and, in some cases, interventions are poorly defined.13 Case-Smith et al.13 identified five
studies specifically examining SIT, of which only two33,34 were RCTs. SIT was described in these studies
as ‘ . . . clinic-based interventions that use sensory-rich, child-directed activities to improve a child’s
adaptive responses to sensory experiences’.13
Both RCTs33,34 included in the review13 demonstrated positive effects of SIT on the Goal Attainment
Scale (GAS). There were, however, methodological issues with both trials, including small sample sizes
[i.e. no formal sample size calculation and use of convenience samples (n = 3733 and n = 3234)], lack
of long-term follow-up33,34 and limited description of usual care.34 There are also well-documented
methodological problems (with validity and reliability) related to the use of GAS as an outcome measure
in clinical trials,35,36 particularly in paediatric contexts.37 However, more recent research indicates that
GAS may be a promising approach to measuring effectiveness of psychosocial interventions in autism
and some recommendations for optimising reliability, including the use of a standardised approach to
writing GAS goals, have been made.38 Nonetheless, uncertainty remains about the use of GAS as an
objective outcome measure in the context of a clinical trial, despite the appeal of an individualised
approach to measurement of what could be considered an individualised form of therapy.
The three remaining studies assessing the efficacy of SIT reported positive effects on behavioural
outcomes linked to sensory difficulties, although it is difficult to draw meaningful conclusions given
the use of non-randomised designs, very small sample sizes and insufficient descriptions of outcome
measures.13 More recent systematic reviews39,40 did not identify any additional RCTs, but reported
positive effects on several functional, developmental40,41 and play outcomes39,42 in two small non-
randomised pilot studies (n = 842 and n = 2041) in which SIT was delivered with adequate fidelity.
Current evidence gaps and research priorities
The current evidence base to support use of SIT for children with autism is of low quality and
insufficient to recommend treatment.17 Significant methodological issues are evident from studies
conducted to date, including poorly described interventions that are unlikely to meet fidelity standards.
Even in randomised studies with good fidelity of intervention delivery, of which several systematic
reviews13,39,40 have identified only two (i.e. Pfeiffer et al.33 and Schaaf et al.34), intervention protocols
were variable in terms of dose and delivery period (e.g. 18 45-minute sessions delivered over 6 weeks
in the Pfeiffer et al.33 RCT and 30 sessions delivered three times per week for 10 weeks in the Schaaf
et al.34 RCT). Conclusions from all studies to date are limited by small convenience samples, poorly
described comparators or definitions of what constitutes ‘usual care’ and a lack of long-term follow-up.
The latter may be particularly important, given the focus of SIT on attention and learning rather than
repetition of specific behaviours. Post-intervention treatment effects may be less specific, and we do
not yet know whether or not SIT demonstrates sustained effects.13
There is also uncertainty around appropriate intervention targets and associated outcome measurement,
given the focus of previous trials on goal attainment as the primary outcome of interest and associated
3
INTRODUCTION
psychometric challenges. Furthermore, aside from considerable variation in the intervention protocols,
SIT is resource intensive and would require significant investment to be rolled out as a potential
treatment option within the NHS. It is critical, therefore, to evaluate both the clinical effectiveness and
the cost-effectiveness of SIT for children with autism and SPDs across a range of key outcomes, and to
determine whether or not any effects are sustained in the longer term.
The SenITA trial
The main aims of the SenITA (SENsory Integration Therapy for sensory processing difficulties in
children with Autism spectrum disorder) trial (see Chapter 3 for methods) were to (1) describe usual
care in trial regions and clearly differentiate this from the proposed intervention (see Chapter 2);
and (2) evaluate the clinical effectiveness of manualised ASI therapy (see Chapter 5) in a two-arm RCT
for SPDs in young children with autism. The intervention was evaluated in terms of the impact on
behavioural problems and adaptive skills, socialisation, carer stress and quality of life (see Chapter 6),
and in terms of cost-effectiveness (see Chapter 7).
Participants with a range of autism and sensory symptom severity, as well as functional and cognitive
ability, were recruited from NHS, educational and third-sector settings. The primary outcome time
point was 6 months post randomisation, and was reassessed at 12 months to determine whether
or not any observed effects were maintained in the longer term. An internal pilot (see Chapter 4)
examined whether or not the intervention differed significantly in content or intensity from usual care
and assessed recruitment and retention. Contamination, adherence and fidelity of intervention delivery
were measured as part of the process evaluation (see Chapter 8). Experiences of the intervention and
usual care were also explored via semistructured interviews with carers and therapists (see Chapter 9).

Chapter 2 Usual care for children with

autism and sensory processing difficulties
Aim
Prior to delivering SIT to trial participants, it was important to describe the scope of usual care for
children with autism and SPDs (as per the commissioning brief). This would ensure that the therapy
offered to the intervention group was clearly different from any treatment offered to the usual-care
group. We aimed to explore the role of OT in the management and support of primary school-aged
children (i.e. children aged 4–11 years) with autism and associated SPDs living in the UK. We wanted
to know how carers and children with autism and SPDs accessed OT services, the nature of any
assessments and whether or not specific interventions and/or support were received along the clinical
pathway. In addition, we wanted to establish the most common behaviour or occupational performance
issues and the profile of associated interventions used for children with autism and SPDs.
Methods
Recruitment and sampling

We were interested in the views of carers and the approaches used by occupational therapists.
We chose a mixed-methods approach. Both carers and occupational therapists completed online
questionnaires and, to build a more detailed picture of OT support provided, we also carried out
qualitative focus groups and subsequent telephone interviews with occupational therapists.
Carer participants
An online questionnaire was distributed to carers of children with autism and SPDs aged 4–11 years
and in mainstream education. The questionnaire was made available via the National Autistic Society
(NAS) website, local NAS groups, social media [Facebook (Meta Platforms, Inc., Menlo Park, CA, USA;
www.facebook.com) and Twitter (Twitter, Inc., San Francisco, CA, USA; www.twitter.com)], flyers at
public events and through the Royal College of Occupational Therapists specialist section on children,
young people and their families.
Occupational therapist participants
Online questionnaires
An online questionnaire was distributed to occupational therapists working with, or who had previously
worked with, children with autism and SPDs aged 4–11 years and in mainstream education. The
questionnaire was first distributed via the Welsh children’s OT network, the occupational advisory
forum in Wales and the head of the children’s OT service in Cornwall. Occupational therapists
from only the original trial recruitment areas (i.e. Wales and Cornwall) were asked to complete the
questionnaire in this first phase and information was also collected on willingness to participate in
focus groups/interviews. The questionnaire was then more widely distributed across the UK through
the Royal College of Occupational Therapists.
Qualitative data collection

Occupational therapists were sampled from those who had participated in the first phase of the online
survey from South Wales and Cornwall, working in the NHS and local authorities. Two focus groups
and six telephone interviews were conducted with occupational therapists currently working, or having
5
USUAL CARE FOR CHILDREN WITH AUTISM AND SENSORY PROCESSING DIFFICULTIES
previously worked, with children with autism and SPDs aged 4–11 years and in mainstream education.
Focus groups were conducted in Wales (group 1 had two participants and group 2 had three participants).
Six occupational therapists in Wales and Cornwall were unable to take part in the focus groups and,
therefore, were interviewed via telephone. Recruitment took place in February 2017, with the aim of
carrying out focus groups before trial recruitment began.
Data collection
Online questionnaire to carers and occupational therapists

Online questionnaire data were collected using the Bristol Online Survey. Participants were presented
with the purpose of the questionnaire and a data protection statement. Participants who agreed
with the statements continued with the remainder of the questionnaire and participants who did
not consent were automatically routed to a thank you screen. Both questionnaires consisted of
a mixture of multiple choice and free-text questions. It was optional for participants to provide
personal information to enable the research team to contact them directly. Respondents were
asked about the nature and severity of common difficulties for children with autism. The carer
questionnaire was separated into six different sections of (1) location (i.e. where the carer lived
and where their child receive care), (2) child behaviours (carers were asked about 12 aspects of
their child’s behaviour and how problematic each of these was for their child), (3) therapy (carers
were asked whether or not their child had received therapy in the last 6 months that addressed
any behaviours listed in the previous questions), (4) information received (carers were asked whether
or not any teams/organisations identified in the previous section provided advice or materials),
(5) intervention received (carers were asked whether their child had ever received or was currently
receiving support from an occupational therapist and the extent of this) and (6) further information
(carers were asked whether or not they would be interested in being contacted to take part in an
interview or a focus group).
Data were merged following completion of all questionnaire phases. Questions to occupational
therapists were split into two broad sections: (1) their role in the work setting and (2) their specific
experience with this population. Occupational therapists were asked about their qualifications and
years of experience; how many children with autism they saw; the type of assessments they completed
and the type and extent of therapy delivered, including theoretical underpinnings for therapy to
address SPDs; the type of occupational performance issues they associated with SPDs; the type of
support and advice they offered children with autism and their families; and whether or not they
would be interested in being contacted to take part in an interview or a focus group.
Focus groups, interview procedure and topic guide

Focus groups and interviews were carried out in English and audio-recorded. Verbal informed consent
was obtained. Interviews were semistructured and consisted of five broad topic sections, beginning
with an ‘ice breaker’ that allowed participants to introduce themselves, describe where they worked
and describe the type of service provided. This ‘ice breaker’ was then followed by questions on usual
practice regarding assessment of SPDs in a child with autism; advice and support given to children
and carers of children with autism; background training in SPDs; and opinion of SIT. The interview
topic guide was initially based on the questionnaire topics, but with further prompts and allowing for
flexibility guided by participant responses. The guide was further adapted after the first focus group
to shape ongoing data collection. The same topic guide was adapted for telephone interviews. Focus
groups were conducted face to face, facilitated by an independent qualitative researcher with an
additional note-taker/co-facilitator present. All telephone interviews were carried out following the
focus groups by a second qualitative researcher, after having listened to audio-recordings of focus
groups for familiarisation of the topic. All focus groups and interviews were transcribed verbatim for
analysis and anonymised.

Ethics approval and data management

All activities adhered to the Research Governance Framework for Health and Social Care. Ethics
approval was granted by a Health Research Authority Research Ethics Committee. All respondents
consented to participate in questionnaires, interviews or focus groups.
Analyses
Online questionnaires
Descriptive analyses were used in the form of frequency tables for the quantitative data, and included
summaries of the geographical area of respondents, nature of reported difficulties and contact with
services, and information on OT assessment and treatment received. Free-text comments within
questionnaires provided context and additional explanation for some responses. Examples have been
included to give meaning and carers’ lived experience of services received. Free-text comments within
questionnaires completed by occupational therapists were incorporated into the thematic analysis of
focus group and interview data.
Focus groups and interviews

Transcripts were analysed using thematic analysis. This involved data familiarisation, generating
initial themes, and searching, reviewing and defining themes.43 The first two steps were carried
out as a team by two experienced qualitative researchers and two members of the research team
who were experienced occupational therapists. The final analyses were undertaken by the lead
qualitative researcher.
We carried out a thematic analysis using deductive methods to identify themes reflecting reality
as reported across the whole data set. We initially coded data within six overarching themes (i.e.
referral, initial assessment, initial management, further assessment, treatment plan/intervention,
feedback and future plans) relating to the different phases of OT support for children with autism
and SPDs. In addition, we used an inductive thematic approach to identify occupational therapists’
views, experiences and challenges relating to these processes, moving towards a more contextualist
approach and ensuring that subthemes, which had not been pre-empted and initiated from occupational
therapists themselves, were identified. These subthemes were factors influencing decisions around
which assessment occupational therapists used (at child, OT and system level), factors influencing
the location of assessment, the multifaceted nature of interventions, empowering others, and making
interventions achievable for parents and schools. This analysis was then integrated with the results of
the questionnaires. While interpreting the qualitative data we produced a visual map of the different
phases of management of children with autism and SPDs (Figure 1). We developed this map this in a
phased way, starting with one account in an interview and building on this with each new transcript,
revising and incorporating as we progressed. In this way, data were constantly compared and contrasted.
Developments in the analytic process were recorded through researcher memos and version control
of the visual maps. The first transcript was discussed in detail and themes developed by a group of
qualitative researchers and occupational therapists. Themes were then applied to the next transcript
and discussed again. The research team were encouraged to reflect on their own professional role in
asking and interpreting interview questions.
Results
Carers’ views of usual occupational therapy for children with autism and sensory
processing difficulties
A total of 159 carers responded to the questionnaire. Most (n = 149, 93.7%) carers were mothers.
We received six (3.8%) responses from fathers, two from grandmothers (1.3%), one from a kinship
7
Factors influencing which

Assessment with occupational therapist assessment used:
1. Child – age, reason for referral and
• Conversation with carers (history, current presentation, gain consent for future
stage of development
intervention) and child (age dependent)
2. Occupational therapist – experience
• Informal/play-based observation, usually in school/nursery or home
of different assessment tools,
• Formal measures
training/qualifications in
assessment tools, competence
in interpreting measures and
confidence
3. System – location of assessment,
Presentation is minor More than one area of difficulty/cluster of sensory problems time, availability of measures
• Advice and information

(to carers and/or school) Sensory workshop/ More detailed assessment with
• No further occupational training course occupational therapist Advice/information
therapist input • Observation (school/nursery) shared with carers/
• Open access so can and/or home school/referrer and
self-refer Carers apply strategies • Discussion with carers and teacher(s) may be used for
at home • Sensory assessment (SPM or SP) educational health-care
• Measures taken plan
• Goals set
No further follow-up
needed
Occupational therapist develops individualised therapy
programme/treatment plan, including
• Sensory movement-based strategies
• Sensory diet
• Rebound therapy
• SIT principles
• Multifaceted interventions
• Empowering parents and achievable interventions
Ring if questions Write open

Try out at home: then ITP Open access access
Working (around (discharge)
reviewed by occupational
well 24 months) report
therapist
• GAS
• Informal evaluation from Still
challenges Amend/
carers/school update ITP Follow-up
FIGURE 1 Routes of support described by occupational therapists. ITP, individualised therapy programme/treatment
plan; SP, sensory processing; SPM, Sensory Processing Measure.
carer (0.6%) and one from an educational visitor (0.6%). The spread of respondents across geographical
regions is shown in Table 1. Thirty-two (20.1%) respondents were from Wales, 115 (72.3%) were from
England, 11 (6.9%) were from Scotland and one (0.6%) was listed as ‘other’ (location not specified).
Nature of reported difficulties

The most frequently reported difficulties were difficulties with relationships and communication
(84.3%) and difficulty making friends/joining in/playing with others (83.6%), followed by refusal to carry
out daily activities (73.6%) and outbursts without any obvious reason (73.6%). A total of 77.3% carers
reported at least moderate difficulty with sensory hyper-reactivity and 49.6% of participants reported
at least moderate hyporeactivity. Being overactive and having repetitive behaviour that interrupts
activity were reported by 64.8% of carers. Other difficulties encountered included sleeping difficulties
(59%), poor co-ordination (56%), poor performance in school (54.1%) and feeding difficulties (39.6%).
Less common difficulties included anxiety (n = 8, 5%), hyperacusis (n = 2, 1%), hypermobility (n = 2, 1%),
poor concentration (n = 2, 1) and violent behaviour (n = 2, 1%).

TABLE 1 Respondents by geographic region/university health board
Geographic area by country n (%) University health board/region n (%)
Wales 32 (20.1) Aneurin Bevan University Health Board 7 (4.4)
Cardiff and Vale University Health Board 15 (9.4)
Cwm Taf University Health Board 4 (2.5)
Hywel Dda 4 (2.5)
Swansea Bay University Health Board 1 (0.6)
Wales other 1 (0.6)

England 115 (72.3) Buckinghamshire 1 (0.6)
Cornwall 11 (26.4)
Dorset 2 (1.3)
England other 101 (63.5)
Scotland 11 (6.9) Scotland 11 (6.9)
Other 1 (0.6) Other 1 (0.6)
Carers’ views on contact with services

A total of 119 (74.8%) carers reported some contact with services [e.g. children’s centres (health service)
and local authorities (social care services)] in relation to difficulties in the last 6 months. Professionals
seen within these organisations included occupational therapists (NHS and private), speech and language
therapists, paediatricians, psychologists (clinical and educational), dieticians and specialist teachers.
However, 40 (25.2%) carers reported that they had received no therapy/support in relation to their
child’s difficulties in the same period. Further detail regarding contact with services is given in Table 2.
TABLE 2 Contact with services (n = 159)
Service Contact, n (%)
Children’s centre (health service provision) l Yes: 26 (16.4)

l No: 133 (83,6)
l If yes, monthly or more often: 8 (5.0)
Special school l Yes: 4 (2.5)

l No: 155 (97.5)
l If yes, daily: 2 (1.3)
Local authority (social care provision) l Yes: 50 (31.4)
l No: 109 (68.6)
CAMHS l Yes: 43 (27.0)

l No: 116 (73.0)
Specialist autism team l Yes: 46 (28.9)

l No: 113 (71.1)
CAMHS, Child and Adolescent Mental Health Services.
9
Ninety (56.5%) carers received information and advice on how to manage their child’s difficulties, such
as anxiety, behavioural and sensory difficulties. Although 68 (42.8%) carers received specific advice on
sensory information from services, a further 46 (28.9%) carers would have liked more information on
these aspects of their child’s difficulties. Where advice and information on sensory issues had been
given, this was most commonly by OT services. However, sometimes other NHS and third-sector
organisations provided similar information. Information was typically in leaflet form and included
information on sensory processing, exercises/programmes to do at home, social stories and contact
information/websites for parent courses.
Carers’ views on occupational therapy assessments and treatment

Seventy (44.0%) carers had not received any input from OT services. Those who had received input
(n = 89, 56.0%) generally received input in the form of assessment and observation plus advice.
Assessment was most frequently through a carer questionnaire and observation of play. A few carers
reported more formal testing of co-ordination skills. If direct intervention was offered, then this was
typically for a limited block of therapy (e.g. four to eight sessions). Of the carers (89/159) who had
received input from OT services, 64 (40.3%) were not currently in contact with an occupational therapist.
Of the 44 carers who had seen an occupational therapist in the last 6 months, 10 had received more than
five sessions in that period. In terms of length of overall contact with OT services, the majority of carers
were discharged within a 6-month period (n = 76, 85%).
Of those carers who had ever received OT input, 15 (16.8%) reported that they had received weekly
input and most visits were clinic based (n = 57, 35.8%), with intervention varying from sensory based
(not SIT), parent-directed programmes, functional skills training, sensory diets and behavioural
programmes. Most carers (n = 58, 36.5%) stated that the intervention that they received focused on
sensory modulation. Fewer carers (n = 22, 13.8%) received intervention for both sensory modulation
and dyspraxia, and an even smaller number of carers (n = 9, 5.7%) received intervention for dyspraxia
alone. Forty-three (27.0%) carers reported that the intervention focused on other aspects, such as
anger management, behavioural difficulties, speech and sleep. Carers were asked further details about
specific interventions that their child received in terms of whether or not they felt that the therapy
helped their child, how satisfied they were with the intervention received and whether or not they
would recommend any changes to intervention delivery.

Five (3.1%) carers had accessed OT privately and had received, or were in receipt of, SIT at least once
per week. All five carers felt that SIT had helped their child and reported high satisfaction with the
intervention. However, all five carers also felt that longer-term therapy (i.e. more than six sessions)
would be beneficial and/or that it should be available on the NHS.
Other interventions received

The intervention most often received by carers was adaptation to the home or school environment
(n = 115, 72.3%), and 88 (76.5%) carers thought that adaptations helped their child and 83 (77%)
carers were satisfied with the adaptations. Other interventions included sensory diets (n = 54, 34%),
behavioural interventions (n = 42, 26.4%), parent-directed programmes (n = 45, 28.3%), functional skills
training (n = 25, 15.7%) and sensory-based interventions (n = 24, 15.1%). Fewer carers (n = 16, 10.1%)
received advice on desensitisation strategies. Generally, more respondents were satisfied with sensory
diets (n = 40, 77%), desensitisation strategies (n = 12, 75%) and parent-directed programmes (n = 28, 65%)
than behavioural interventions (n = 19, 51%). When asked whether or not interventions helped their child,
carers felt that desensitisation strategies (n = 12, 75%), sensory-based intervention (n = 16, 66.7%)
and functional skills training (n = 16, 64%) definitely helped their child. Carers were less certain about
sensory diets (n = 28, 51.9%), parent-directed programmes (n = 20, 44.4%) and behavioural intervention
(n = 15, 35.7%). When asked whether or not there was any aspect of the interventions/advice received
that they would wish to change, carers commonly said that they would have liked additional input and
direct support for their child, rather than just advice. Some carers noted that they would have liked
10

more access to OT and speech and language therapy (SLT) support through the NHS. Several carers
specifically requested training and support into schools to manage sensory difficulties (n = 11), as they
felt that the school was not able to carry out the sensory support required. Some carers would have
liked more specific advice for their child, including follow-up and monitoring visits, rather than generic
information that was not personalised:
I would love for this intervention to be available as more than a one-off appointment with me as a
parent. I would love to be able to access sensory support/therapy for my children on a regular basis.
Carer 66
Specific advice from a qualified OT [occupational therapist] specialising in sensory difficulties not just a
parent googling what to try – trial and error as totally without support from NHS.
Carer 9
Make it available to everyone via the NHS. NHS input was limited and generalised, we had excellent input
from a private OT [occupational therapist].
Carer 155
NAS website and research online; family and friends particularly those with children who have autism;
colleagues at work.
Carer 145
Detailed responses of the interventions received by families are provided in Table 3.
TABLE 3 Interventions received by families (n = 159)
Strategy/intervention Intervention received, n (%)
SIT at least once per week l Yes: 5 (3.1)

l No: 150 (94.3)
l N/A: 1 (0.6)
l Do not know: 3 (1.9)
l If yes, did SIT help your child?
¢ Yes, definitely: 5 (100)
Sensory-based interventions l Yes: 24 (15.1)

l No: 120 (75.5)
l N/A: 2 (1.3)
l If, yes, did sensory-based interventions help your child?
¢ Definitely yes: 16 (66.7)
¢ Maybe: 8 (33.3)
Desensitisation strategies l Yes: 16 (10.1)

l No: 135 (84.9)
l N/A: 4 (2.5)
l Missing: 4 (2.5)
l If yes, did desensitisation help your child?
¢ Yes: 12 (75.0)
¢ Maybe: 3 (18.8)
¢ No: 1 (6.2)
Parent-directed programmes l Yes: 45 (28.3)

l No: 108 (67.9)
l N/A: 1 (0.6)
l If yes, did parent-directed programmes help?
¢ Maybe: 22 (28.9)
¢ Definitely no: 3 (6.7)
continued
11
TABLE 3 Interventions received by families (n = 159) (continued )
Strategy/intervention Intervention received, n (%)

Sensory diets l Yes: 54 (34.0)
l No: 100 (62.9)
l N/A: 4 (2.5)
l If yes, did the sensory diets help?
¢ Maybe: 23 (42.6)
¢ Definitely not: 3 (5.6)
Behavioural intervention l Yes: 42 (26.4)

l No: 111 (69.8)
l N/A: 2 (1.3)
l If yes, does behavioural intervention help?
¢ Maybe: 14 (33.3)
Environmental adaptation l Yes: 115 (72.3)

l No: 39 (24.5)
l N/A: 1 (0.6)
l If yes, did environmental adaption help?
¢ Maybe: 24 (20.9)
Functional skills training l Yes: 25 (15.7)

l No: 123 (77.4)
l N/A: 9 (5.7)
l Missing: 2 (1.3)
l If yes, did functional skills training help?
¢ Maybe: 7 (28.0)
N/A, not applicable.
Finally, when asked what types of intervention would be the most useful, the most common carer
responses were additional support for social communication (n = 16), desensitisation and other sensory
issues (n = 15), support for managing behaviour, including aggression, anger and anxiety (n = 14), and
specific SIT (n = 12). A significant number of carers reported having to source support via independently
accessed behaviour training (n = 81, 50.9%) and regular contact with support groups (n = 87, 54.7%),
and 81 respondents (50.9%) received informal support from family and friends:
Sensory integration therapy for social and behaviour skills.

Carer 5
More help with socialising with his peers so that he does not become socially isolated.
Carer 25
Help with controlling/managing violent outbursts.

Carer 47
12

Intervention specifically aimed at sensory issues in school.

Carer 68
Someone to work with my child teaching them about their sensory differences and how to manage them
whilst exploring what works/doesn’t and teaching them coping techniques at their own pace.
Carer 77
Occupational therapist views of usual care
Questionnaire responses by occupational therapists

The questionnaire was completed by 79 occupational therapists. In phase 1, 38 questionnaires were
completed by occupational therapists working in trial recruitment areas (i.e. Wales and Cornwall).
In phase 2, 41 questionnaires were completed, including by occupational therapists in England
and Scotland. Occupational therapists were generally very experienced: 53 (67.1%) occupational
therapists reported having at least 10 years’ post-qualification experience and only 10 (12.7%)
reported having < 5 years’ post-qualification experience. Eighteen (22.8%) occupational therapists
reported postgraduate qualifications, with 11 (13.9%) specifically in sensory integration. Almost all
(n = 77, 97.5%) occupational therapists reported seeing one or more children with autism and SPDs
in the last 6 months, with 15 occupational therapists (15.2%) seeing more than 10 children each.
However, only 11 (13.9%) occupational therapists were based within a specialist autism service.
The settings in which children were seen included children’s centres, special and mainstream schools,
local authority settings, Child and Adolescent Mental Health Services (CAMHS) and the child’s home.
Most occupational therapists saw children referred for one to five contacts/sessions (n = 39, 49.4%),
with only three (3.8%) occupational therapists seeing children for between 10 and 20 contacts/sessions.
The frequency of contact was very varied, with the most common frequencies being weekly (27.8%),
monthly (19%) or twice per month (17.7%). Most occupational therapists maintained contact with
families for 3 months (n = 26, 32.9%) or 6 months (n = 20, 25.3%) prior to discharge.
Focus groups and interviews with occupational therapists

Two focus groups and six semistructured telephone interviews were conducted following the online
survey, representing the views of 11 occupational therapists working in South Wales, Mid-Wales
and Cornwall. Respondents described themselves as occupational therapists, paediatric occupational
therapists and occupational therapist senior practitioners, and had experience of working in autism
assessment units, core services, in the community, within the NHS, in social services and in the local
authority. This section integrates occupational therapists’ views on usual care gathered from
questionnaires, focus groups and interviews. Illustrative quotes are provided.
Nature of reported difficulties and referral

Survey responses indicated that the most common problems seen by occupational therapists included
poor performance in school (n = 61, 77.2%), poor co-ordination and motor planning (n = 57, 72.2%),
and refusal to carry out typical daily activities, sleep and outbursts without understandable reason
(n = 56, 70.9%). Sixty-seven (84.8%) respondents felt that sensory hyper-reactivity hindered children’s
engagement in activities, with 50 (63.3%) respondents reporting that hyporeactivity could be a factor
hindering engagement. In focus groups/interviews, occupational therapists reported that referral may
be via health professionals [e.g. general practitioners (GPs), paediatricians and professionals in SLT
and mental health services], other services (e.g. integrated services for children with additional needs,
education services and social services) or via carer self-referral. Referral criteria varied slightly,
but required a child to demonstrate functional difficulties and SPDs, rather than behavioural and
emotional problems alone, and did not necessarily require a diagnosis. One occupational therapist
stated that they did not have clear written criteria setting out what they would and would not accept.
13
Occupational therapists described that a triage meeting would take place at which occupational
therapists and colleagues determined the appropriateness of a referral. Occupational therapists
describe using clinical reasoning and professional experience to consider the information:
So it’s difficult to say whether people meet criteria because our criteria is still, it’s not always clear;
it’s a little bit woolly but I think that’s quite historically common for OT that the criteria for a service
for OT is generally quite woolly because we do cover such a wide remit.
Interviewee 4
Yes, there are a few of us here that are trained in using SIPT [Sensory Integration and Praxis Test],
so sometimes we will do that for the children that are more highly functioning ASD, and that’s quite
good because it gives us a really good profile on what their skills are, and their things to work on.
Interviewee 5
Theoretical framework underpinning decision-making

Most OT survey respondents reported that clinical reasoning within the referral, assessment and
intervention process involved using OT theory as a guide (n = 76, 96.2%), with 55 (69.6%) respondents
supporting this with sensory integration theory (27 respondents specifically referred to ASI). Other
approaches included neurodevelopmental (n = 47, 59.5%), applied behavioural analysis (n = 29, 36.7%)
and social approach (n = 8, 10.1%).
Assessment process
Most OT survey respondents reported using informal or structured clinical observations within the
home, school or clinic setting (n = 68, 86%). In the focus groups/interviews, occupational therapists also
talked about the value of observing informal activity. One occupational therapist compared informal
and formal clinical observations and the different ways of thinking required for occupational therapists
to process information. Occupational therapists also talked about sensory play as a way to practically
demonstrate the challenges that the child and carer(s) face.
Occupational therapists reported that this observation was carried out alongside interviews/questionnaires
and a developmental history with carers (n = 45, 57%), teachers (n = 22, 27.9%) and the child (n = 12,
15.1%). In addition, 33 (41%) survey respondents reported using a specific OT assessment of functional
daily life skills. Forty-five (57%) respondents reported using a specific measure to assess SPDs [e.g. Sensory
Profile 224 and the Sensory Processing Measure™ (SPM)44]. Fewer (n = 15, 19%) survey respondents
reported using measures to assess motor difficulties (e.g. Movement Assessment Battery for Children-2
and Bruininks–Oseretsky Test of Motor Proficiency-245).
Occupational therapists also mentioned other measures [e.g. the Peabody Developmental Motor
Scales,46 clinical observations assessment,47 the Canadian Occupational Performance Measure48
(COPM), Movement Assessment Battery for Children,49 The Roll Evaluation of Activities of Life
Occupational Therapy assessment,50 Beery Visual Motor Integration51 and Kate Malcomess’ Care
Aims Framework52]. Occupational therapists in the diagnostic assessment team and one other core
service reported that they might use the Autism Diagnostic Observation Schedule (ADOS)53 or specific
SLT assessments. Some occupational therapists used the Sensory Integration and Praxis Test54 (SIPT)
in case studies if they had undertaken training in sensory integration (but did not then use this
therapy in usual care), whereas others said that they did not have access to SIPT equipment.
Only one occupational therapist said that they used the SIPT routinely.
In focus groups/interviews, occupational therapists reported that they talk with carers and schools/
nurseries to set goals. Older children will discuss goals too. Occupational therapists described
instruments used to support goal-setting [e.g. the Perceived Efficacy in Goal Setting Approach,55,56
14

Child Occupation Self-Assessment,57 SMART (Specific, Measurable, Achievable, Relevant, Time bound)
goals58 and Kate Malcomess’ Care Aims Framework52]. However, one occupational therapist explained
that they do not always have to use formal assessment/goals if sufficient information is gained through
observation or is offered by the carer or child.
In focus groups/interviews, occupational therapists talked of assessment as an ongoing process.

In deciding which assessment to use, occupational therapists considered different factors relating to
three areas, that is, the (1) child, (2) occupational therapist and (3) wider system. At the level of
the child, assessment choice depended on their age, stage of development, concentration level and
reason for referral. At the occupational therapist level, assessment depended on their experience,
training/qualifications in different tools, competence in interpreting measures, and personal confidence
and preference. Finally, at the system level, assessment depended on location, time available, waiting
list pressures, availability of measures and the focus for that service. The location of assessment also
depended on several factors. Occupational therapists reported that location of observation was
selected to limit distress to the child while determining the problem with greatest impact. The age of
the child may also influence the setting for observation.
Again, reason for referral was also considered. Some occupational therapists said that they would see
the child in their usual environment where difficulties presented and/or in another environment with
carers (e.g. school/nursery). One occupational therapist also explained that the child would usually
come to the children’s centre, as there was equipment there that could be tried out. If the child was
to receive the intervention, then they would often be seen on several occasions in different locations.
The location of assessment was also influenced by the ability of the carer to visit the clinic owing to,
for example, socioeconomic status or learning difficulties:
Well I think in the battery of assessments that you have, and the observations that you can do it very
much depends on the child because a lot of the children with autism they would get freaked out with
maybe doing standardised assessments and you can’t, you have to do it by observation and play then.
You’re very much guided when you meet the child on the day really . . .
Participant 1, focus group 1
. . . so we use a sensory profile, but it’s again down to the individual therapist, it’s not something that we
necessarily do for everyone every time. We use just clinical observations and observing them in their home
environment and their school environment, so that’s our main, I would say that’s our main first contact is
just clinical obs [observations] and chatting to the parents and seeing how they are and then we may
decide to use a sensory profile if we need to get a clearer picture.
Interviewee 4
If the child is going to be put in distress through coming to a new environment and a strange environment,
and would be distressed in that setting, then you’re not going to get the best thing from that child, so that
would influence my clinical decision of where I carried that out.
Interviewee 3
Advice and interventions

Frequency strategies described by OT survey respondents are detailed in Tables 4 and 5.
We then used interview and focus group data to understand the different phases of OT support and
interventions for children (see Figure 1).
Presentation assessed as minor after initial assessment with occupational therapist

In focus groups/interviews, occupational therapists reported that if presentation was ‘minor’ then the
carer/child would receive advice and information, but no further input. The carer/child may be provided
with website addresses, handouts and signposting to other services. In addition, the carer/child would
usually have the option to self-refer later if needed.
15
TABLE 4 Therapist advice given to carers
Therapist advice to carers n (%)
Information on the senses 66 (83.5)
Introducing new/adapted sensations 32 (40.5)
Sensory diet 48 (60.8)
Advice to improve response 41 (51.9)
Physical environment 69 (87.3)
Social environment 51 (64.6)

Other 16 (20.3)
TABLE 5 Interventions for children/families
Intervention for children/families n (%)
Sensory based 42 (53.2)
Desensitisation 32 (40.5)
Parent directed 38 (48.1)
Education 56 (70.9)
Sensory diets 58 (73.4)

Behavioural 29 (36.7)
Adaptations (physical and social) 62 (78.5)
SIT 5 (6.3)
Sensory carer groups

Occupational therapists reported (in focus groups/interviews) that for more than one area of difficulty
and/or a cluster of sensory problems, carers may be invited to attend a parent group (e.g. a one-off
workshop or course of around three sessions). These sessions often consisted of an interactive element
involving peer support (e.g. where carers shared difficulties and solutions) and professional support
(e.g. providing theory and professional advice). A group with multiple sessions allows carers time to
identify triggers/concerns, discuss and try out strategies, and then return to evaluate effectiveness
of these strategies. Occupational therapists suggested that these groups give carers a foundation
knowledge about sensory processing and help them to understand their child’s individual needs.
Sensory movement-based strategies, sensory diet and rebound therapy

Survey respondents reported that the most common intervention offered was advice on adaptation
to the environment to accommodate sensory needs (n = 62, 78.5%) and activities for a sensory diet
(n = 58, 73.4%).
Occupational therapists reported (in focus groups/interviews) that, based on observation, assessment
and goal-setting, they would develop an individualised therapy programme/treatment plan with
carers and the school/nursery. This would often involve multiple sessions (around four to six). A wide
range of strategies might be drawn on and a plan provided for an individual child to try at home or at
school/nursery. These strategies might include sensory movement-based strategies (e.g. vestibular and
proprioceptive activities, such as heavy muscle work, yoga-type movement, peanut roll, scooter board,
lycra blanket, soft play and sensory-weighted equipment) and may also include deep touch pressure,
16

massage and brushing for alerting and desensitising, calming strategies and mindfulness, and swimming.
Some equipment might be used for assessment/observations and treatment, for example therapy
rooms with a smartboard, Wii Fit (Nintendo Co., Ltd, Kyoto, Japan), weighted blankets, supportive
chairs or trampolines (interview 1). Another occupational therapist (interviewee 3) mentioned that
they had a loan system for sensory items (e.g. weighted products, dance mats, vibrating items, seating
and lap pad). Carers might have delivered strategies themselves or a technician/occupational therapist
would offer a demonstration. One occupational therapist reported that they also offered groups that
families can link into, such as bike skills groups, gymnastics and social skills groups.
Occupational therapists might also advise group interventions (e.g. The Alert Programme and Sequential
Oral Sensory approach) or multidisciplinary team working/referral to other services [e.g. a portage
worker, a specialist health visitor, a neurodevelopmental team, NAS, Barnardos (London, UK), primary
mental health, a specialist autism service in the school, Autism Puzzles (Cardiff, UK) and a disability
sports officer]. Occupational therapists also spoke of linking and contributing to transdisciplinary groups,
including Next Steps, Early Bird, Early Bird Plus and Cygnets.

Five (6.3%) survey respondents reported delivering SIT. However, most (n = 55, 69.6%) respondents
reported using sensory integration theory to inform practice and 19 (24.1%) respondents had
undertaken postgraduate sensory integration training equivalent to ≥ 50 hours (i.e. the minimum
requirement for trial therapists). Most interventions used were targeted at sensory modulation and/or
dyspraxia (n = 44, 55.7%). Similarly, most occupational therapists reported that they either were not
able to use ASI therapy in its pure form because of time or space, or did not use it at all. Occupational
therapists who had received training in SIT said that they try to consider its principles, but expressed
frustration that they could not carry it out. Only one occupational therapist reported using SIT ‘as
much as possible’ for specific children, including using swings and climbing frames, wobble cushions,
scooter boards and scooter board ramps, weighted balls and a range of wet and dry tactile exploration
items (e.g. texture mats, textured balls, textured quoits, vibration balls, vibrating snakes and cushions),
as well as trampettes that could be used at home:
We have a very positive response to it. And the number of parents that say oh if only we had known this.
So yeah, it’s a very positive way of meeting a lot of people’s needs. And it also saves the therapist’s time,
because otherwise what we feel is that those parents that then seek further intervention, they have a
baseline of knowledge. And we all know what that level of knowledge is, so that we can start working at
that higher level rather than having to cover the same groundwork individually with each child.
Interviewee 2
We don’t provide it, we don’t have any funding to provide that type of sensory equipment, but we do
have access to them to be able to trial them for a 2-week period. After the trial we then make a decision
whether we suggest that for the parents or the schools, or nursery or wherever that child is, to purchase
that piece of equipment. But we don’t have funding to provide that.
Interviewee 3
In the house, and in the centre, we use a lot of suspended type equipment, so we’ve got things like T-bars,
we have platform swings, and we have bolster swings. We have climbing frames, tyre swings, all that type
of stuff.
Interviewee 5
Multifaceted interventions
Occupational therapists tended to describe the interventions that they offered as varied and
multifaceted. Some occupational therapists highlighted the non-standardised nature of developing
and delivering interventions. However, occupational therapists described using an evidence base,
their clinical experience and the needs of the individual child to guide intervention/strategies.
17
Empowering parents and achievable interventions

Many occupational therapists (in focus groups/interviews) felt that an important part of intervention
delivery was the carer’s motivation to engage with the intervention, as well as their ability and confidence
to deliver the intervention. An important part of the occupational therapist’s role was empowering carers
to continue the intervention. Occupational therapists reported that barriers to carers implementing
strategies included the carer’s understanding of their child, other family commitments and child engagement.
Occupational therapists reported that the effectiveness of interventions was also dependent on teachers’
ability to deliver the intervention. Therefore, occupational therapists stressed the need to make the
intervention achievable and manageable at home and/or school:
In isolation it means nothing. You can carry out 30-odd sessions, but once that intervention finished it’s
finished, unless the parent and the child . . . For me, the powerful bit is carrying that over into the child’s
everyday life so it continues.
So I think for me it feels like it’s empowering others to do this work and then to understand what
it is to provide it every day for the child feels more normal than going to a clinic setting all the time.
Less medical. Nobody wants to be going somewhere . . . Children have got lives to live themselves and
fun to have.
Evaluating the intervention plan, reports and open access

Occupational therapists (in focus groups/interviews) reported that after strategies had been tried
at home and/or at school/nursery for several weeks the plan was reviewed, often using the GAS,35
an evaluation questionnaire and/or informal evaluation from carers or the school.
Discussion
Representativeness of views
The views reflected within our data were collated from survey responses from occupational therapists
and carers in Wales, England and Scotland, and from interviews/focus groups conducted with
occupational therapists in South Wales and Cornwall. The purpose was to determine how carers and
children with autism and SPDs access OT services, the assessment process and what interventions
and/or support are commonly provided. Determining the nature of usual care within trial areas and
the wider UK context would ensure that our comparator was sufficiently different from SIT delivered
in the intervention arm of the trial.
Theoretical approaches to intervention

Survey responses indicated that occupational therapists utilised OT theory to guide assessment and
intervention. This core philosophy values human participation in meaningful occupations59 and this is
reflected in the criteria that occupational therapists use to choose whether or not to accept a referral
for assessment. Within the broader scope of theoretical approaches, sensory integration theory was
reported as the most common approach to help to understand and manage SPDs. This is consistent
with findings from Kadar et al.,60 who found that 72.7% of occupational therapists used a sensory
integration frame of reference. Likewise, Brown et al.61 reported that sensory integration and
client-centred practice models were most commonly used in a survey of Canadian paediatric
occupational therapists.
Accessing services and the referral process

Although services differ, there appeared to be a common trend across the regions surveyed. From both
quantitative and qualitative data, it was clear that most children were seen for initial assessment
only if they met specific referral criteria, particularly with regard to SPDs affecting daily functional
18

activities. Many services would not accept a referral unless there were clear occupational performance
difficulties in self-care, play or school-related activities. It is likely that this more focused approach
has been driven by increasing waiting lists for access to OT,62 ensuring that only the most appropriate
children received therapy. There have also been government drivers to ensure that children are
seen within 14 weeks of referral (e.g. the NHS Wales Delivery Framework and Reporting Guidance
2019–202063). From the carers’ perspective, understanding of what OT services could offer their
child was less clear cut. Carers wanted support for their child’s social interaction, help with dealing
with aggressive outbursts/frustration, help with understanding autism and help with siblings. Fewer
carers listed functional skills, such as toileting, feeding, dressing and sleeping, as behavioural issues
seemed to have a greater impact on quality of life. Respondents were, therefore, frustrated because
they felt that they could not always access the service that they perceived would help them and their
child, and expressed disappointment that services were not always offered by the NHS.
Assessment process
Both occupational therapists and carers reported that initial assessment included observations,
interviewing the caregiver, questionnaires and, sometimes, more formal assessments. Observations of
the child’s behaviour and performance were typically within the clinic setting and, to a lesser extent,
within the school or home environment. Standardised assessments were not used routinely. Although
most therapists reported using a sensory integrative approach, only very few reported using the SIPT
to formally identify the nature of the sensory integration difficulty.
Some settings used structured goal-setting with carers to establish the child’s needs. There has
been a consistent drive in recent years to develop family-centred practice, with services working in
partnership to address concerns and goals.64 From this survey, it appears that some carer concerns
were addressed and that most were satisfied with the advice given, but many would have liked more
input. After initial assessment, most services generated a report with advice on strategies for managing
SPDs in everyday life. For some parents, contact with services ended at this point or they were
referred to a workshop/training group. For others, additional OT support was received with further
discussion and advice, the offer of loan of suitable equipment to support their child’s needs or some
sessions of one-to-one intervention.
Intervention
Therapists appeared to have a two-pronged approach: (1) giving strategies and advice to support
carers to manage their child’s SPDs to improve self-regulation, and (2) attempting to address SPDs
directly with the aim of remediation of the dysfunction and underlying nervous system.65
Strategies and advice to manage sensory processing difficulties

Both occupational therapists and carers concurred that strategies and advice were most commonly
provided. Occupational therapists used a range of strategies, from advice including environmental
adaptations, sensory diets and desensitisation strategies, which may take the form of generic advice,
to more personalised advice following individual sessions. According to carers, the sensory-based
interventions, sensory diets and parent-directed programmes helped in over 65% of the children
receiving them. However, carers still felt that this was not enough and wanted ongoing support.
Carers also wanted better transfer of advice and strategies into the school setting, more personalised
intervention and further follow-up as the child developed. In terms of transfer of knowledge and to
run an efficient service, several therapy services offered parent/carer groups with general information
about sensory processing. Although carers found this useful, they also wanted more specific application
to their own child’s difficulties.
Direct intervention
Carers and some occupational therapists expressed frustration that direct hands-on therapy was not
always possible because of resource constraints. Carers particularly felt that they were missing out on
intervention and that they had to seek support privately. Respondents whose children had received
19
SIT were extremely satisfied and all felt that it had helped their child. Very few therapists in the NHS
reported using SIT meeting fidelity criteria,23 but some were using sensory-based interventions, applying
theory and principles of sensory integration and delivered less intensively for shorter periods. These
interventions included activities applied to the child to improve behaviour associated with modulation
disorders,13 such as massage, brushing, wearing a weighted vest or sitting on a gym ball.
Summary
Sensory-based difficulties are commonly reported in this population, and there is a clearly expressed
demand from carers for additional contact and support from OT services. Current provision of usual
care and most services offered focus on delivering sensory strategies and advice. This may be in the
form of generic written information that is web based or a bespoke leaflet, or through parent groups
or one-to-one consultation with carers. Some direct therapy may be offered using a sensory integration
approach, but this usually comprised fewer than 10 sessions. Intensive treatment offered by a therapist
with SIT training is available within the private sector and so is inaccessible for many carers.
20

Chapter 3 Methods
Design
The SenITA trial was an individually randomised two-arm effectiveness trial that compared manualised
SIT with usual care for children of primary school age with autism and SPDs. Randomisation was in
a 1 : 1 ratio and was minimised by site, severity of SPDs (i.e. probable/definite) and sex of the child
(i.e. male/female). The target was to recruit 138 children aged between 4 and 11 years in primary education.
Children were recruited from a variety of sources, including CAMHS, OT services, paediatric clinics, support
and/or social services and primary schools, and via self-referral. The intervention was delivered in OT
clinics that were rated to ensure that they met full structural fidelity criteria for manualised SIT.
Children allocated to receive the intervention were provided with SIT in 26 1-hour sessions (Figure 2),
that is face-to-face sessions twice per week for 10 weeks, tapering to twice per month for 2 months,
and a telephone call once per month for 2 months. Where consent was provided, sessions were video-
recorded, with a sample of recordings assessed for fidelity of delivery.23 The comparator was usual
care, which was defined as awaiting services or sensory-based intervention not meeting fidelity criteria
for SIT (e.g. at least one face-to-face session per week).
The trial also included an internal pilot (see Chapter 4) with progression criteria to assess recruitment
and retention rates and whether or not usual care differed from expected provision.
Qualitative work included therapist and carer interviews to explore (1) the support experienced by
families (outside the trial, i.e. usual care) and (2) the perceived impact and effectiveness of SIT for
children with autism and SPDs. Interview and focus group data were double coded and analysed using
a framework approach.66 Ethics approval was granted by Wales Research Ethics Committee 3.
Objectives
The overarching objective was to answer the following research question: ‘what is the clinical
effectiveness and cost-effectiveness of SIT for children with autism?’.
Primary objective
The primary objective was to determine the impact of SIT on irritability and agitation, as measured by
the corresponding subscale of the Aberrant Behavior Checklist (ABC).67
Secondary objectives
Secondary objectives were included to examine:
l the effectiveness of SIT for additional behavioural difficulties (e.g. hyperactivity/non-compliance,

lethargy/social withdrawal, stereotypic behaviour and inappropriate speech)
l the impact of SIT on adaptive skills, functioning and socialisation
l sensory processing scores post intervention (i.e. at 6 months) as a potential mediator of any
association observed between SIT and the primary outcome at 12 months
l age, severity of SPDs, adaptive behaviour, socialisation and comorbid conditions as potential moderators
of any association between SIT and irritability/agitation, adaptive functioning (child) and carer stress
l the impact of the intervention on carer stress and quality of life
l cost-effectiveness (including direct intervention costs, costs of health, social care and education
services, carer expenses and lost productivity costs)
l fidelity, recruitment, acceptability, adherence, adverse effects and contamination in a process
evaluation conducted alongside the main trial.
21
METHODS
Identification of potential participants
Informed consent and screening

assessment for eligibility: SPM
Baseline assessment and randomisation: ADOS,

VABS, ABC, APSI, EQ-5D, CarerQol and CSRI
Intervention arm (SIT) 26 weeks

Carer guided on - (1-hour) activities
Initial assessment: SIPT, COPM,

clinical observations and
background history
Control arm (usual care)
Usual care recorded by carers

Intensive phase: 2 × 1-hour
(paper/electronic diary)
sessions per week for 10 weeks
Usual-care contact = one (or no)
session per week
Tailoring phase: 2 × 1-hour with advice to parents
sessions per month for 2 months
Usual care for ASD recorded
Telephone phase: 1 × 1-hour

telephone session per month for
2 months
6-month assessment: SPM, 6-month assessment: SPM,

VABS, ABC, APSI, EQ-5D, VABS, ABC, APSI, EQ-5D,
CarerQol and CSRI CarerQol and CSRI
Qualitative interviews Qualitative interviews

(between 6 and 9 months) (between 6 and 9 months)
12-month assessment: VABS, 12-month assessment: VABS,

ABC, APSI, EQ-5D, CarerQol ABC, APSI, EQ-5D, CarerQol
and CSRI and CSRI
FIGURE 2 The SenITA trial participant flow diagram. APSI, Autism Parenting Stress Index; CarerQol, Carer Quality of
Life; CSRI, Client Service Receipt Inventory; EQ-5D, EuroQol-5 Dimensions.
Site selection
Secondary care NHS and private OT treatment settings (where NHS capacity was insufficient to
support the trial or no appropriate NHS treatment setting was available) across South Wales and
South England were included as research sites. Sites evidenced that they met structural fidelity criteria
for intervention delivery.
22

Participants
Inclusion criteria
Participants were eligible to take part if they:
l had a diagnosis of autism (as documented on medical and/or educational records) or had probable
or likely autism (defined as undergoing assessment within the local autism pathway)
l were aged 4–11 years at the start of the trial
l planned to remain in mainstream primary education until the primary outcome time point
(i.e. 6 months post randomisation)
l had definite or probable SPDs defined as (1) definite dysfunction on at least one sensory dimension
(defined as all domains except social participation) and the total score on the SPM44 or (2) at least a
probable dysfunction on two or more sensory dimensions and the total score
l provided carer consent/child assent.
Exclusion criteria
Participants were excluded if they were:
l currently undergoing or had previously undergone SIT

l currently undergoing applied behaviour analysis therapy.
Recruitment process
Children were recruited from CAMHS, paediatrics, OT, schools and support or social services. Services
sent carers of children referred into their service a letter informing them about the trial, as well as a
participant information sheet (PIS) and details of how to express an interest in taking part. Details of
the study were also posted on relevant websites (e.g. related charities’ websites) and via social media.
A trial-specific website [URL: http://senitastudy.weebly.com (accessed 7 April 2022)] was also created
as a place where individuals could get more information on the trial and could download information
sheets. Carers were also able to self-refer into the study.
Informed consent
It was likely that potentially eligible children could have a range of impairments, including a degree of
intellectual disability (ID). Provided that all inclusion criteria were met and exclusion criteria were not
met, no child was excluded for this reason or for other comorbid conditions. In accordance with good
clinical practice (GCP), written informed consent was taken from each child’s carer (i.e. their parent or
legal guardian) and assent from children before any trial-related activities were undertaken. In signing
the consent form, carers also consented to their participation in the trial (including completion of some
outcome measures) and for the study team to contact the child’s school to ask for feedback on the
child’s behaviour if necessary. Schools were also asked to complete the Aberrant Behavior Checklist –
irritability (ABC-I) at the 6-month time point. Consent could be withdrawn by carers at any time.
To complement the carers information sheet, age-appropriate information was presented to the child
where appropriate and the views of children capable of expressing an opinion considered. Children
deemed to have capacity and who were able to write were asked to sign an age-appropriate assent form.
Consent was sought from carers to video-record intervention sessions to assess fidelity of intervention
delivery and for supervision feedback. Carers could also consent to video-recordings being used in
future research or for training opportunities. In addition to intervention sessions, ADOS53 assessments
were video-recorded to evaluate consistency among ADOS assessors. Refusal of consent to any video-
recording did not affect the participants’ eligibility to otherwise take part in the trial. Carers received a
copy of any consent form that they signed, with the original filed in the site file and a further copy held
with participants’ clinical notes.
23
METHODS
Once recruited to the trial, treating therapists remained free to give participants alternative treatment
to that specified in the protocol if it was in the child’s best interest; however, the child would remain a
participant in the trial for the purpose of follow-up and data analysis according to original treatment
allocation. Further informed consent was taken from a small number of carers for participation in
qualitative interviews. In compliance with Welsh-language requirements, the PIS, consent form and
any other required participant documentation were available in Welsh. However, all outcome measures
were available in English only, as none was validated in Welsh.
Risk assessment
A trial risk assessment was completed to assess:
l known and potential risks and benefits to participants

l the level of intervention risk compared with standard practice
l how risks were to be minimised/managed.
The SenITA trial was categorised as low risk (i.e. no higher risk than standard medical care).
This categorisation was used to inform the level and focus of monitoring activity undertaken
during the trial.
Intervention

The intervention was delivered in regional clinics by OTs trained in SIT (typically NHS band 7)
(see Chapter 5 for a description of the intervention). None of the therapists delivering the intervention
delivered therapy to participants in the control arm. Fidelity of intervention delivery was assessed
using the ASI intervention fidelity measure (see Chapter 8).23
Comparator
To define usual care, scoping work in the form of a short survey, interviews and focus groups with
therapists and carers was completed before the trial opened to recruitment (see Chapter 2). Carers also
recorded usual care using a diary that was specifically designed for the trial. This could be completed
either on paper or electronically. Usual care for autism was also recorded more generally, including
any contact with NHS services (e.g. SLT, paediatrics and CAMHS). Therapists recorded usual care in
accordance with local policy.
Outcomes
Screening and baseline measures
Screening measure
Sensory processing difficulties were assessed at screening using the SPM Home Form.44 This version
of the SPM provides eight standard scores: (1) social participation, (2) vision, (3) hearing, (4) touch,
(5) body awareness (proprioception), (6) balance and motion (vestibular function), (7) planning and
ideas (praxis), and (8) a total sensory symptoms score. Scores on each of these dimensions are
classified as typical, some problems or definite dysfunction. To be eligible, participants’ SPD was
defined as either (1) definite dysfunction on at least one sensory dimension (defined as all domains
except social participation) and the total score or (2) at least probable dysfunction on two or more
sensory dimensions and the total score. Participants scores on this measure were made available to
treating SIT therapists to aid planning of intervention delivery.
24

Baseline-only measure
An ADOS assessment was completed at baseline to characterise the sample according to autism
symptoms. Results of the ADOS were not shared with carers or therapists and it was not used as
a diagnostic tool to determine eligibility. Members of the study team attended research reliability
training for the ADOS and cascaded essential training to other members of the study team
undertaking assessments. Reliability and consensus of administration and scoring was assessed
as per the ADOS manual. A sample of video-recorded ADOS administrations were also used to
facilitate assessment of reliability.
Primary outcome measure

The primary outcome was irritability/agitation at 6 months post randomisation, as measured by the
corresponding ABC subscale (i.e. the community version ABC-I with 15 items67,68). The ABC-I was also
measured at baseline and at 12 months post randomisation. The primary outcome comparison was
based on carer ratings of ABC-I. However, teacher/teaching assistant ratings of ABC-I (assessed at
6 months post randomisation only for intervention and control arms) were also explored.
Secondary outcome measures
Problem behaviours
Other problem behaviours were measured at baseline and at 6 and 12 months using the remaining
four ABC subscales: (1) lethargy/social withdrawal (16 items), (2) stereotypic behaviour (seven items),
(3) hyperactivity/non-compliance (16 items) and (4) inappropriate speech (four items). Although
moderate correlations between subscales are generally observed, researchers are advised not to
use a total score, as construct validity is poor.69 For all ABC subscales, items were rated on four-point
Likert scales, ranging from 0 (not at all a problem) to 3 (the problem is severe in degree).
Adaptive behaviours, socialisation and functional change

Adaptive behaviours, socialisation and functional change were assessed at baseline and at 6 and
12 months using the parent/carer rating version of the Vineland Adaptive Behavior Scales, second
edition (VABS II).70 VABS II comprises four main domains: (1) communication (i.e. receptive, expressive
and written), (2) daily living skills (i.e. personal, domestic and community), (3) socialisation (i.e. interpersonal
relationships, play and leisure time, and coping skills) and (4) motor skills (i.e. gross and fine motor skills).
Start points of each Vineland Adaptive Behavior Scales (VABS) subdomain vary depending on the child’s
chronological age. Gross and fine motor skills are included in the composite score for younger children
only (i.e. children aged 0–6 years).
Carer stress
Carer stress was assessed using the Autism Parenting Stress Index (APSI)71 at baseline and at
6 and 12 months. The APSI is a 13-item measure of parental stress, covering the social, physical
and behavioural issues that characterise autism. Each item is scored according to five categories:
(1) ‘not at all stressful’, (2) ‘sometimes creates stress’, (3) ‘often creates stress’, (4) ‘very stressful on
a daily basis’ and (5) ‘so stressful that sometimes I/we feel we cannot cope’.
Quality of life
Carer quality of life was measured using two measures: (1) the EuroQol-5 Dimensions, five-level
version (EQ-5D-5L),72 scale and (2) the Carer Quality of Life (CarerQol).73 EuroQol-5 Dimensions
(EQ-5D) is a health-related quality-of-life scale that is made up of five dimensions: (1) mobility,
(2) self-care, (3) usual activities, (4) pain/discomfort and (5) anxiety/depression. The EQ-5D is
assessed via single items with a five-category response option. These five dimensions are scored
and combined into an index value using an algorithm. The EQ-5D is recommended for use in health
technology assessments and includes a measure of general self-rated health on a vertical visual
25
METHODS
analogue scale with end points labelled ‘best imaginable health state’ and ‘worst imaginable health
state’. The CarerQol instrument was used to measure and value the impact of providing informal
care on carers. It combines a subjective burden measure that provides a comprehensive description
of the caregiving situation using the Carer Quality of Life – 7 Dimensions (CarerQol-7D), with a
valuation of informal care in terms of well-being [i.e. the Carer Quality of Life – visual analogue scale
(CarerQol-VAS)].73 The CarerQol has been shown to be valid in populations of caregivers of children
with autism.74
Functional change
The COPM48 was used to measure functional change in the intervention arm only, as participants
assigned to usual care were not routinely seen by services. High scores on the COPM indicate higher
performance and satisfaction. If the average pre- and post-intervention difference was more than
2 points, this was regarded as clinically important.
Mediators
In addition to screening, SPM scores were assessed at 6 months to determine whether or not any
effects of the intervention on the primary outcome at 12 months were mediated by severity of SPDs
post intervention.
Cost-effectiveness outcomes
Staff and non-staff inputs directly associated with the intervention and usual care were recorded
during the intervention period for each participant. Data were collected on services and support
external to the intervention at baseline (covering the previous 6 months) and at 6 and 12 months post
randomisation. The Client Service Receipt Inventory (CSRI)75 was adapted based on expert opinion for
use in this study. It was used to collect service and support data for participants and data on health-
care and social care services used by the child’s main carer, including out-of-pocket expenses incurred
by the carer and time taken off work because of SPDs and autism difficulties experienced by the child
they care for.
Randomisation
Using an online system, participants were randomly allocated to usual care or SIT in a 1 : 1 ratio.
Randomisation utilised minimisation with a random component, which allocated participants to the
group that caused the least imbalance. Minimisation included region (i.e. Wales or England), severity
of SPD (i.e. SPM score) and sex of child.
Sample size
The initial aim was to recruit 216 participants in total (i.e. 108 participants allocated to usual care and
108 participants allocated to the intervention), which was based on 90% power at the 5% significance
level to detect a standardised effect size of 0.5, allowing for 20% loss to follow-up.
The standardised effect size of 0.5 was arrived at by considering mean scores on the ABC-I found in
the literature. Mean scores in control/untreated groups of between 12 and 24 were quoted, as well as
standard deviations (SDs) of between 6 and 10. It is suggested that a 25% relative difference/effect
size of between 0.4 and 1.0 represented a clinically meaningful difference on ABC subscales. We chose
a conservative effect size of 0.5. The calculation was carried out using nQuery v3.0 (Statistical
Solutions, Saugus, MA, USA).
26

However, following the internal pilot (see Chapter 4), an aim of which was to check assumptions used
for the sample size calculation, a high correlation was found between baseline and 6-month ABC-I
scores [0.86, 95% confidence interval (CI) 0.60 to 0.96]. Accounting for this result led to a revised
sample size of 138 (usual care, n = 69; SIT intervention, n = 69) by applying a deflation factor.76
This target assumed a correlation of 0.6, which was a conservative estimate to allow for the potential
of a lower correlation at the end of the study, any therapist clustering and any reduction in retention
as the study progressed. This target assumed that correlation was also consistent with previous RCTs77
in this field that used the ABC-I (which found correlations in ABC-I scores of 0.647 and 0.599 between
baseline and 16 weeks post randomisation and between baseline and 10 months post randomisation,
respectively).
Procedures
Trial oversight and patient and public involvement

The trial was conducted in accordance with Centre for Trials Research standard operating procedures.
Oversight was provided by the Trial Management Group (including the investigators and directly
employed trial staff), the Trial Steering Committee, the Data Monitoring and Ethics Committee and
an advisory group of family carers. The advisory group, including the patient and public involvement
co-investigator, provided feedback on study materials, recruitment and retention plans, and continue
to advise on dissemination of results to stakeholders.
Staff training
Good clinical practice training was provided to staff carrying out trial-specific procedures (e.g. recruitment/
consent, data collection and intervention delivery). Tailored training materials were created for all aspects
of intervention delivery and data collection (see Intervention data collection). Principal investigators
(PIs) and intervention therapists received an individualised session on delivering the intervention in
accordance with the study protocol, following the detailed description in the intervention handbook
(see Chapter 5). Therapists clearly marked participant consent on their clinical notes.
Sensory integration therapy sessions

Safeguarding procedures were in place for reporting or raising any concerns that arose during
therapy sessions, and these procedures were detailed in the intervention handbook. It was the
responsibility of each therapist to make participant’s session appointments. Future appointments
were agreed at the child’s first assessment visit and recorded on an appointment card for carers to
keep. The card held contact details for the therapist, including who was the first point of contact for
carers and an emergency contact number. It was also the therapist’s responsibility to issue reminders
of upcoming appointments and to reschedule appointments as necessary. If a participant could not
attend a session as intended, up to two attempts could be made to reschedule within ± 3 days of
the original appointment. If a session could not be rearranged to fit in that time frame, then it would
be foregone.
For each session, therapists documented and video-recorded (where consent was given) the
intervention delivered. Video-recordings were uploaded to password-protected secure OneDrive
(Microsoft Corporation, Redmond, WA, USA) folders for fidelity analysis. Once uploaded, video-
recordings were deleted from the recording device.
Assessment time points

Outcomes and follow-up time points (Table 6) were the same for both the intervention and the control
group and were performed as close as possible to the required time point.
27
METHODS
TABLE 6 Schedule of enrolment, interventions and assessments
Visit
Follow-up
Procedure Screening Baseline Treatment phase 6 months 12 months
Informed consent ✗
Demographics ✗
Eligibility assessment: SPM ✗ ✗
Randomisation ✗
ABC ✗ ✗ ✗
ABC-I (teacher rated) ✗

ADOS ✗
APSI ✗ ✗ ✗
CarerQol ✗ ✗ ✗
CSRI ✗ ✗ ✗
Quality of life: EQ-5D ✗ ✗ ✗
VABS II ✗ ✗ ✗
COPM ✗ (intervention group only)

Delivery of intervention ✗
(including initial assessment)
Diary completion ✗
SAEs As necessary
Withdrawals As necessary
SAE, serious adverse event.
Data collection
A manual (Table 7) was created for research assistants carrying out any data collection. The document
was created to ensure consistency of data collection from different research assistants and research
network staff. Data were entered directly into the trial SQL (Structured Query Language) database via
an online link, with the exception of the ADOS and VABS II, which were scored on paper first and then
relevant total scores entered online.
The study team contacted carers to rearrange any missed follow-up data collection appointments
as soon as possible. For those carers who were unable to attend appointments in person (or stay for
the duration), there was the option to complete any remaining measures at home using a booklet that
was to be returned to the study team. Those carers who were unable or unwilling to take the booklet
home were given the option of answering key questions over the telephone. All individuals carrying
out data collection (i.e. research assistants and clinical study officers from research networks) were
appropriately qualified and completed relevant training. Clarification of any clinical questions relating
to SIT that arose during appointments was deferred to the co-chief investigator.
Screening and baseline visit

There were two screening/baseline visits, which were split to reduce any burden on the child taking
part. At the first meeting, the study team met with only the carer to discuss the study in detail and
to take consent. Following consent, the carer completed the screening measure (i.e. the SPM) to
confirm eligibility. If eligible, the carer was immediately asked to complete the baseline outcome
28

TABLE 7 Contents of the research assistant data collection manual
Section Content
1 Introduction
2 Key aspects of study protocol:
l Participant eligibility
l Recruitment
l Screening and consent
l Randomisation
3 Informed consent
4 Study procedures:
l Equipment
l Collecting participant appointment information
l Checking eligibility
l Study explanation and taking consent
l Adding participant to database
l SPM screening
l Baseline assessments
l Contact information
l Administering VABS
l Scoring VABS
l End of session 1 – explanation to carer of next session
l Beginning of session 2 – explanation to child of study
l ADOS assessment
l Uploading VABS and ADOS scores
l Making recordings
l Importing session recordings from the camera
5 The SenITA data collection portal
6 Withdrawals
7 GCP
8 AE (safety) reporting
9 Monitoring and ethics
10 Key contacts
AE, adverse event.
measures (see Table 6). If not eligible, the carer was thanked for their interest and no further trial
involvement took place. If the carer could not complete the baseline assessment immediately, then it
was arranged for a convenient time.
The second meeting was held during the following week to complete an ADOS assessment (video-
recorded where consent was given) with the child and to carry out randomisation. Carers in both
arms were given access to a diary at this point to report health professional contacts and any home
programmes or self-initiated activities for their child (Figure 3).
Follow-up data collection

Follow-up assessments for all participants were conducted 6 and 12 months after randomisation with
a ± 4-week window. Reminders were sent out to participants/carers to complete the diaries using the
text message service Esendex (Commify UK Ltd, Nottingham, UK). The text message system was also
used to supplement data collection where necessary.
29
METHODS
Participant referred
for screening
Check level of child

literacy by asking if Following session 2
ADOS 2/3 would
Get appointment be most suitable
information from
OneDrive
Check with parent if Score ADOS

child would be able
to complete assent
Check form
eligibility
No
Score VABS
Yes
Explain next session
to parent
Explain study
Upload ADOS and

Thank participant VABS to iPad
for their Explain study diary
participation and to parent
explain why they
Consent participant
are ineligible to take
part in the study. Notify the SenITA
The session will end team by e-mail that the
here participant is ready
Confirm for randomisation
appointment time
Register participant
in online database
Prepare room
Complete SPM before arrival of
assessment – show parent and child
video if not seen
No
Session 2 (ADOS
assessment)
SPM eligible
Explain study briefly

Yes to child using the
child information
sheet
Complete iPad (Apple
Inc., Cupertino, CA,
USA) assessments
(all baseline other
than ADOS and Take assent if child
VABS to be marked is capable
as complete)
While parent is
Ask parent to completing form,
complete contact highlight areas to be Administer ADOS
information form completed on VABS assessment
paper form
Ask parent to
Thank parent and child
complete VABS
for their time and explain
paper form
next steps
Check scoring of
VABS paper form
and go through any
questions
FIGURE 3 Flow diagram of data collection procedures.
30

Intervention data collection

Therapists delivering the intervention were provided with written guidance in the form of a manual
on how to collect and record all aspects of trial data (Table 8). The manual was very detailed and
gave step-by-step instructions on using trial equipment, including screen shots and pictures to aid
explanation. Each intervention therapist was given access to an iPad, which had been preloaded with
links to the purpose-built trial SQL database and individual OneDrive accounts. Intervention therapists
were also given access to a digital camera and tripod to record the intervention sessions.
Once a participant had been randomised to receive the intervention, the next available therapist in
their area was sent an e-mail to notify the therapist that a child had been allocated to them. The
therapist then logged into their personal OneDrive space to pick up contact details for the participant
and to arrange their first appointment. During the initial assessment, the therapist used their personal
log-in details to access the secure trial database. The therapist completed online forms for the COPM48
and clinical observations. Therapists also completed the SIPT54 with each child. The SIPT was not
available electronically and, therefore, therapists filled out a paper booklet with the child. To score the
test, the booklet was sent to the trial team, who held the scoring software. To ensure that data were
sent securely, therapists uploaded scans of each page of the booklet to their OneDrive account for the
trial team to score. The SIPT report was then sent back to the therapist via OneDrive.
TABLE 8 Contents of the SenITA intervention therapist data collection manual
Section Content
1 Introduction
2 Key aspects of study protocol:
l Participant eligibility
l Recruitment
l Screening and consent
l Randomisation
3 Intervention
4 Study procedures:
l Taking receipt of equipment

l Use of iPads:
¢ Being allocated a new participant
¢ Booking appointments
¢ Uploading SIPT test results
¢ SIPT results
¢ The SenITA data collection portal
l Opening previous session notes

l Amending previous session notes:
¢ Making recordings
¢ Importing session recordings from the camera
¢ Mentorship folder (OneDrive)
¢ Study documents folder (OneDrive)
l Withdrawals
5 GCP
6 AE (safety) reporting
7 Monitoring and ethics
8 Key contacts
AE, adverse event.
31
METHODS
At the start of each intervention session, the therapist set up the camera and tripod to record the
session. All recordings were transferred from the camera to the iPad and were uploaded to OneDrive.
Recorded sessions could then be shared via OneDrive with relevant mentors and fidelity assessors,
who were also given university-allocated single-use OneDrive log-in details. The manual included a
flow diagram that each therapist could refer to (Figure 4).
Receive e-mail notification:

you have been allocated
a new participant
Guidance for
Get participant
participant
information from
allocation on
OneDrive
page 8
Arrange first Guidance for

appointment booking
(assessment appointments
phase) on page 8
Complete SIPT,
Non-therapist tasks
COPM and clinical
Guidance for
observations
SIPT upload on
assessments and
page 14
upload SIPT to
CTR staff score OneDrive
SIPT and upload
results
Complete COPM Guidance for
and clinical completing
observations online online forms
forms on page 18
Receive notification Guidance for

of SIPT results and SIPT results on
retrieve results page 17
Plan intervention
Process during session
sessions and goals
Feedback from and review with
Sue Delport/ Guidance for
Sue Delport/ recording
Kath Smith Kath Smith Video session
sessions on
page 26
Sessions 1–20
(intensive phase)
Complete sensory Guidance for
integration checklist completing
online form online forms
on page 18
Sessions 21–24
(tailoring phase)
Guidance for
Upload session
uploading
video
video on page 28
Sessions 25 and 26
(telephone phase)
FIGURE 4 Flow diagram for therapist data collection. CTR, Centre for Trials Research.
32

There were occasions when technology failed (e.g. when camera batteries ran out and when the
camera failed to record), which led to some missing recordings. Intervention therapists received
detailed training alongside the manual; however, there were several occasions where the trial team
had to go out to site to help with technical issues. All data transfer and storage strictly adhered to
GCP data handling and security specifications.
Scoping focus groups with therapists

Prior to recruitment, focus groups and a small number of telephone interviews were held with
clinicians providing treatment for SPDs to explore what was currently delivered/received as usual care
in the health boards/trusts involved, and what, if any, difference existed in local provision and between
regions (see Chapter 2 for full details). A small number of one-to-one telephone interviews were also
held to supplement focus group data.
Interviews with carers and therapists (carried out during the trial)
Interviews took place either face to face or over the telephone. Interviews were audio-recorded and
transcribed verbatim, with references to identifiable personal details, such as name, address and date
of birth, removed (see Chapter 9 for full details).
Data management
Data collection was via a web-based SQL database. This secure encrypted system was accessed by
username and password, complying with General Data Protection Regulations.78 Back-up paper case
report forms were available in the event that the web-based system was not accessible. A full data
management plan was signed off prior to data collection.
Safety reporting
All serious adverse events (SAE) were reported immediately (and within 24 hours of knowledge of the
event) to the study team by the PI at the participating site. The PI assessed each SAE to determine the
causal relationship, which could not be downgraded by the chief investigator. The chief investigator
then assessed expectedness of the event. There were no expected adverse events (AEs) or SAEs for
the SenITA trial. Any planned treatments at the start of the study were not considered as AEs or SAEs.
Serious adverse events were reported from time of signature of informed consent, throughout the
intervention period and then for a further month. All other AEs not classified as serious were not
routinely collected, although none was reported.
Analyses
Analysis population
Participants were analysed based on the arm to which they were randomised. Main analyses were
based on a modified intention-to-treat population, with those providing outcome data included in the
analysis. A full intention-to-treat analysis set comprised all participants in the group to which they
were randomised, with missing outcome data imputed using multiple imputation. This analysis set
served as a sensitivity analysis to the primary outcome. Finally, a complier-average causal effect
population comprised participants with outcome data in the group to which they were randomised,
accounting for those who received the intervention as intended. This analysis set also served as a
sensitivity analysis to the primary outcome.
33
METHODS
Main analysis
The primary outcome analysis compared trial arms by fitting a linear regression to ABC-I scores at
6 months post randomisation, including a trial arm indicator (i.e. usual care/intervention), adjusting for
baseline ABC-I, recruitment region (i.e. South Wales/South England region), severity of SPD (i.e. some
problems/definite dysfunction) and sex of the child (i.e. male/female). We found no evidence of therapist
clustering and, therefore, fitted single-level models only. Findings are reported as adjusted mean
differences with associated 95% CIs and p-values.
Most secondary outcomes were analysed similarly. Teacher-assessed ABC-I was collected at 6 months
only and, therefore, no baseline ABC-I adjustment was made for this analysis.
Subgroup analysis
We explored differential intervention effects on the ABC-I at the 6-month post-randomisation time
point by age, severity of SPDs and comorbid conditions [i.e. attention deficit hyperactivity disorder
(ADHD), ID or other neurodevelopmental/genetic conditions], site (n = 7), region (n = 2) and sex
of the child. Our primary model was extended by including subgroup × trial arm interaction terms.
These subgroup effects were also explored for APSI scores at 6 months post randomisation.
Sensitivity and exploratory analysis
Adjusting for missing data

Assuming that data were missing at random, given observed data, we used multiple imputation to
investigate the potential influence of missing outcome data on the primary outcome. Specifically, we
used Markov chain Monte Carlo procedures, assuming a multivariate normal distribution and fitting
25 imputations with an imputation model containing baseline ABC-I scores, region, sex and severity of SPD.
Adjusting for intervention receipt

We described the proportion of participants randomised to the intervention arm who initiated therapy
using frequencies and percentages. Furthermore, we similarly described the proportion of participants
randomised to SIT who received at least 13 SIT sessions during the intensive stage of the intervention
and the absolute number of sessions received. Distinctions were made between intervention receipt
that occurred prior to and following the primary outcome time point (i.e. 6 months post randomisation).
Finally, we fitted instrumental variables regression models (estimated using two-stage least squares)
to explore the relationship between intervention receipt and the primary outcome, while maintaining a
comparison of groups as randomised. We considered the following three definitions of intervention receipt:
1. initiated intervention prior to 6-month follow-up (yes/no)

2. received at least 13 out of 20 sessions during the intensive stage of the intervention prior to 6-month
follow-up (yes/no)
3. total number of sessions received prior to 6-month follow-up.
For the last definition, our model coefficients provided an estimate of intervention effectiveness per
session received. Therefore, we multiplied coefficients by 26 to provide an estimate of the intervention
effectiveness in those who received the intervention in its entirety.
Accounting for the COVID-19 pandemic

We conducted a series of sensitivity analyses to assess the impact of the COVID-19 pandemic on
our findings:
l We re-fitted our primary analysis for participants followed up during the pre-pandemic period
(i.e. pre 23 March 2020).
l We considered intervention effects in a hypothetical pandemic-free world, whereby any outcomes
measured where intervention receipt (at least 13/20 intensive sessions attended prior to follow-up)
34

was affected by the pandemic were set to missing and multiple imputation used to impute all
missing values. The imputation model was similar to the original imputation model, with the addition
of an indicator variable for whether the outcome was measured or should have been measured
during the intrapandemic period.
l We considered intervention effects in a world including a pandemic, where outcome data relating to
participants who did not receive the intervention (as per our definition) were retained, and if the
outcome was measured (or should have been measured) during the intrapandemic period was
conditioned on in both imputation and analysis models.
Modelling outcomes over time

We fitted mixed linear regression models, accounting for the correlated nature of repeated observations
within individuals (at 6 and 12 months post randomisation), to our primary and secondary outcome
measures. Models adjusted for baseline measures and variables balanced on at randomisation.
Comparing agreement between teacher- and carer-rated ABC-I scores

We constructed Bland–Altman plots, calculated one-sample t-tests (on the difference in measures
within participants) and calculated 95% limits of agreement to assess the agreement between
teacher- and carer-rated ABC-I scores at 6 months.
Mediation analysis
We planned to conduct mediation analyses to explore whether or not any effect of the intervention
on behavioural problems at 1 year (on all ABC subscales) was mediated through an effect on sensory
sensitivities immediately post intervention.
Comparing Canadian Occupational Performance Measure scores pre and

post intervention
We compared COPM scores collected at sessions 1 and 24 for participants in the intervention arm
using paired t-tests.
Health economic analysis

The health economic analyses were carried out on an intention-to-treat basis. The main analyses
compared cost and cost-effectiveness of SIT with usual care at the 6-month follow-up, and were
conducted from an NHS and Personal Social Services (PSS) perspective. Secondary analyses adopted
a societal perspective, adding education services, carer out-of-pocket expenses and lost productivity
to NHS and PSS. The ABC-I at 6 months was used, in turn, as a measure of effectiveness in a series
of cost-effectiveness analyses. The main cost-effectiveness measure was incremental cost per point
improvement on the ABC-I (at 6 months).
Qualitative analysis
Qualitative data were analysed using thematic analysis43 to search across the data set to find repeated
patterns of meaning and to identify key themes and subthemes. Double coding was carried out until
consensus was reached. The qualitative component was designed using the principles of the Critical
Appraisal Skills Programme qualitative checklist to ensure the quality of qualitative research.79
Additional detail regarding qualitative methods is provided in Chapters 8 and 9.
Process evaluation
A process evaluation (see Chapters 8 and 9) was conducted to examine (1) recruitment, (2) retention,
(3) fidelity, (4) acceptability, (5) adherence, (6) adverse effects and (7) contamination of intervention
delivery within the trial. Recruitment rates/patterns, attendance and intervention fidelity were
assessed quantitatively, whereas the acceptability of study processes and measures, intervention
implementation and acceptability, and the role of contextual factors were examined through the
qualitative interviews with therapists and carers.
35
Chapter 4 Internal pilot evaluation

A s per the requirements of the commissioning brief, the design included an internal pilot with
progression criteria. Assessments as to whether or not criteria were met and, subsequently,
whether or not the trial should progress to a full effectiveness evaluation were made following
recruitment of the first 40 participants. The methods and results for the pilot evaluation are
presented in this chapter.
Aims and objectives
The aim of the internal pilot was to assess the feasibility of recruitment and retention, and to gauge
the nature of usual care provided for SPDs (in the control arm). Specific objectives centred on
providing early evidence of whether or not the study could be delivered in its entirety and covered
the following elements.
Usual care
Usual care was expected to comprise use of sensory-based strategies not meeting fidelity criteria for
SIT and no treatment at all in a significant proportion of cases (established via methods described in
Chapter 2 and from carer diaries).
Recruitment of participants
Recruitment feasibility criteria would be met if at least 70% of those approached were eligible and at
least 50% of those eligible were willing to be randomised.
Retention of participants at 6 months post randomisation

If dropout at the 6-month follow-up time point exceeded 20%, then we proposed to reassess the
sample size calculation and associated implications for feasibility of recruitment.
Contamination (i.e. the extent to which participants allocated to the control arm received
treatment/therapy similar to that in the intervention arm)
Carer-completed diaries were qualitatively assessed to determine whether or not usual care was
sufficiently different from the intervention. Broadly defined, this criterion would be considered met
if carers in the control arm did not receive any intervention meeting criteria for full SIT.
Adherence (i.e. receipt of intervention by participants allocated to the intervention arm)

An ‘effective’ dose for SIT has not yet been established. However, attending 13 of a possible 20 sessions
delivered during the intensive intervention phase (two-thirds) was felt likely to indicate sufficient
exposure, based on clinical experience and previous trials (see Chapter 5).13,33,34,80
Fidelity of intervention delivery

A random sample of SIT sessions (lasting at least 15–20 minutes) delivered by individual therapists were
evaluated using the fidelity measure.23 To demonstrate adequate fidelity, therapists were expected to
score least 80 out of 100 on the process fidelity measure for at least 80% of sessions rated. Each clinic
was also assessed for suitability (of environment and equipment) prior to participant recruitment.23
Sample size assumptions

To confirm the accuracy of the sample size calculation and other features of our proposed design,
we obtained an estimate of the following: the proportion of participants providing primary outcome
data, the SD of the ABC-I67 at the primary outcome time point (i.e. 6 months) in both trial arms, and
the intracluster correlation coefficient (ICC) of therapists within participants for the ABC-I at the
primary outcome time point (intervention arm only).
37
INTERNAL PILOT EVALUATION
Adverse effects
We studied any adverse effects of study participation.
Outcomes
Primary outcome
The primary outcome for the internal pilot comprised those with prespecified progression criteria,
as set out below.
Usual care
A key progression criterion was to demonstrate that the intervention and comparator were sufficiently
different. To determine this we:
l investigated pre-trial service provision in trial regions, as determined from interviews, focus groups
and survey data from therapists and carers (see Chapter 2)
l qualitatively assessed carer-completed diaries at the 6-month time point.
Recruitment
We calculated the number of children who were:
l eligible (expressed as a proportion of those approached)

l randomised (expressed as a proportion of those eligible).
Retention
We calculated the number of children with missing outcome data at 6 months post randomisation
(expressed as a proportion of those who were randomised and had reached that time point).
Secondary outcomes
Secondary outcomes comprised outcomes without formal progression criteria (see Results:
secondary outcomes).
Contamination
We calculated the number of children allocated to the control arm who received any intervention
meeting criteria for full SIT (as per the fidelity checklist23) and/or more than one face-to-face session
per week, and this is expressed as a proportion of those allocated to the control arm.
Adherence/acceptability
We calculated the number of children allocated to the intervention arm who received at least 13 out
of 20 intervention sessions during the intensive phase (expressed as a proportion of those allocated
to the intervention arm who had reached the less intensive phase) (see Chapter 5 for further
intervention details).
Fidelity
The following fidelity measures were determined:
l structural fidelity, that is the suitability of the clinic environment and equipment (scored as at least
85/110 on the structural fidelity checklist)
l the number of therapists scoring at least 80 out of 100 on the process fidelity measure for at
least 80% of sessions rated (expressed as a proportion of therapists who provide at least one
video session).
38

Sample size assumptions

We calculated the:
l SD of the primary outcome measure (i.e. carer-reported ABC-I at 6 months post randomisation)
l correlation between baseline and 6-month post-randomisation carer-reported ABC-I scores.
Adverse effects
We calculated the number of:
l children reporting at least one SAE (overall and by trial arm)

l different SAEs reported (overall and by arm).
Progression criteria
Prespecified progression criteria are provided in Table 9.
Methods
Statistical methods were descriptive in nature, with continuous data reported as means and SDs or as
medians and interquartile ranges (IQRs), as appropriate, and categorical data reported as frequencies
and proportions. Outcomes were estimated and reported alongside 95% CIs. Correlation coefficients
were calculated (Pearson’s or Spearman’s, depending on distribution) and are presented with
associated 95% CIs.
Qualitative methods employed to establish what was delivered and received as usual care in the trial
regions (prior to the start of the SenITA trial) are described in Chapter 2. The aim of data collection
was to gain a detailed understanding of the usual care provided by occupational therapists for children
with autism and SPDs. This was not intended to be an exhaustive description or generalisable to all
services in the UK.
Results: primary outcomes
Primary outcomes were those with specific progression criteria and are detailed below.
TABLE 9 Criteria for progression from internal pilot to full trial
Per cent required

for determining
Objective Outcome measure Data source progression
Recruitment Number of people eligible (as a proportion of Screening log 70

those approached)
Number of people randomised (as a proportion Screening and recruitment logs 50

of those eligible)
Retention Number of people with missing outcome data at Clinical database 20
6 months post randomisation (as a proportion of
those who have been randomised and reached
the time point)
39
Usual care
A specific requirement of the commissioning brief for this trial was to demonstrate that the
intervention was sufficiently different from usual care. At the point at which we reported on the pilot
evaluation, that is after the first 40 participants were recruited, survey data had been received from
39 therapists and 131 carers with regard to their experiences of delivery and receipt of usual care.
At this stage of the trial, we had also undertaken two face-to-face focus groups (group 1 had two
participants and group 2 had three participants) and six (five individual and one shared) telephone
interviews with therapists (n = 7) in trial regions only. The final survey results and a detailed qualitative
exploration of usual care are provided in Chapter 2; however, characteristics of those who responded
during the pilot evaluation period are given in Results: secondary outcomes, as is a brief summary
of findings.
Therapist characteristics
A total of 39 therapists responded to the survey. Twenty-five therapists were from trial regions
(Wales, n = 22; England, n = 3). Therapists were generally very experienced. In total, 24 out of the
39 (61.5%) therapists reported having at least 10 years’ post-qualification experience and only three
(7.7%) reported having < 5 years’ experience. Most (37/39, 94.9%) therapists reported having seen
one or more child with autism and SPDs in the last 6 months; however, only six (15.4%) therapists
were based within a specialist autism/neurodevelopmental service.
Carer characteristics
A total of 131 carers responded to the survey. Most (124/131, 94.7%) carers were mothers.
We received four (3.1%) responses from fathers, two from grandmothers (1.5%) and one from a
kinship carer (0.8%). The spread of respondents across geographical regions is shown in Table 10.
Summary: assessment of usual care

Most of the contact that children with autism and SPDs and their families had with OT services was
limited to assessment and advice, or provision of information around sensory strategies. Where
interventions were delivered, these were sensory-based interventions, not meeting fidelity criteria
for SIT, and were delivered less intensively and for shorter periods. Sensory-based difficulties were
commonly reported in this population and there was clearly expressed demand from carer respondents
for additional contact and support from OT services. Taken together, the findings of the surveys, focus
groups and interviews indicated that the SenITA trial intervention was significantly different from
usual care in trial regions, and across the UK more widely.
TABLE 10 Respondents by geographical region (pilot evaluation phase)
Health board/trust n (%)
Aneurin Bevan University Health Board 5 (3.8)
Cardiff and Vale University Health Board 12 (9.2)
Cwm Taf University Health Board 4 (3.1)
Cornwall Partnership Foundation NHS Trust 2 (1.5)
Abertawe Bro Morgannwg University Health Board 1 (0.8)

Wales other (non-trial regions) 1 (0.8)
Dorset County Hospitals NHS Foundation Trust 2 (1.5)
England other (non-trial regions) 95 (72.5)
Scotland 9 (6.9)
Total 131 (100.0)
40

Recruitment
We planned to recruit participants from a wide variety of sources, namely via secondary care services
(e.g. OT, paediatrics, CAMHS and specialist autism/neurodevelopmental services), schools, third-sector
organisations and self-referral. We anticipated that most referrals would come from OT and/or specialist
neurodevelopmental services. However, most expressions of interest came from third-sector organisations
(e.g. local NAS support groups) and via self-referral. Reasons for this are likely to be complex, but might
include, for example, the length of time from discharge from OT or specialist autism/neurodevelopmental
services. Some specialist teams also expressed concerns about recruiting participants who were yet to
receive a diagnosis (i.e. children were deemed eligible once they were on the local neurodevelopmental
pathway provided that all other eligibility criteria were met; see Chapter 3 for inclusion criteria).
In England, in particular, some OT services expressed concern that referring patients to the trial could
have raised expectations of families in the area with regard to availability of interventional services,
which they were not currently commissioned to deliver.
The number of people eligible at screening from expressions of interest received
Telephone screening
At the pilot evaluation analysis time point, expressions of interest had been received from 97 people.
Following receipt of an expression of interest, the study team contacted each individual to carry out an
initial telephone screening to confirm potential eligibility. Of the 97 people, 26 had yet to respond to a
request for a telephone screening appointment, six were not interested following our response to their
expression of interest and 14 were ineligible at referral.
Screening assessment
Following the telephone screening, 44 out of 97 potential participants who expressed an interest
completed a screening assessment (with a further seven participants booked for assessment), of whom
42 were eligible (43.3%, 95% CI 33.9% to 53.2%).
The number of participants randomised from those eligible

Of the 42 people screened and eligible, we were able to randomise 40 (95.2%, 95% CI 84.2% to
98.7%), representing 41.2% (95% CI 32.0% to 51.2%) of the 97 people who initially expressed
an interest. Those participants approached were defined as those who self-referred and those
referred by secondary care services. Table 11 illustrates how recruitment figures compared with
our progression criteria.
Retention
The number of participants with missing outcome data at 6 months

post randomisation
We received completed assessments from 13 participants of the 14 expected at the pilot evaluation
time point (92.9%, 95% CI 68.5% to 98.7%). Table 12 illustrates how these data compared with
progression criteria.
TABLE 11 Recruitment figures against progression criteria
Expected n based on prespecified

Item progression criteria Achieved n
Number eligible 68 (70% of those approached) 42 (43.3% of those approached)
Number randomised 34 (50% of those eligible) 40 (95.2% of those eligible)

Expressions of interest received: n = 97.
41
TABLE 12 Retention figures against progression criteria
Expected n based on prespecified

Item progression criteria Achieved n
Number received 11 (80% of those expected) 13 (92.9% of those expected)

6-month post-randomisation data expected: n = 14.
Results: secondary outcomes
Secondary outcomes comprised those outcomes without formal progression criteria.
Contamination
We received 58 diaries and 107 SMS text messages (i.e. via the text service used to collect diary
information; see Chapter 3 for a full description) from participants regarding their use of other services
following randomisation. In the control arm, no participant indicated that they had received any
intervention meeting criteria for SIT (i.e. according to fidelity criteria23 and/or face-to-face therapy
more than once per week).
Adherence/acceptability
Of the 20 participants randomised to receive the intervention, eight participants were expected to
have completed the intervention by the analysis time point, and we received attendance data for
seven of these participants. All seven participants attended at least 13 of the 20 intensive sessions.
Fidelity
All trial clinics were assessed as having met structural fidelity criteria23 prior to opening for recruitment
(see Chapter 8). Our outcome of interest was the number of therapists scoring at least 80 out of 100 on
the process fidelity measure for at least 80% of sessions rated (expressed as a proportion of therapists
who provide at least one video session). Fidelity scores were available for a total of 24 session recordings
across six therapists. The mean fidelity score was 81.8 (SD 12.84). In total, 15 out of 24 (62.5%) sessions
were scored at least 80 out of 100. The general impression score (measured via a single question that
indicates whether or not the therapist intentionally applied ASI intervention theory and methods)
was scored ‘no’ for one session only. The corresponding fidelity score for this session was 45 out of
100. All other sessions were scored ‘yes’. Complete fidelity ratings across all therapists are presented
in Chapter 8.
Other sample size assumptions
Standard deviations for the ABC-I at 6 months post randomisation

The pooled SD for the ABC-I at 6 months was 11.78 (95% CI 8.45 to 19.45).
Correlation between ABC-I score at baseline and ABC-I score at 6 months

Based on 13 observations, the correlation between ABC-I score at baseline and ABC-I score at
6 months was 0.864 (95% CI 0.597 to 0.959).
Adverse effects
No adverse effects were reported.
Summary of progress against progression criteria
Our internal pilot findings are summarised in Table 13.
42

TABLE 13 Summary of internal pilot findings
Outcome Projected Attained Comment
Usual care N/A N/A Intervention is sufficiently different from

usual care
Number of participants randomised 78 40 Lower than expected owing to difficulties

opening sites and limited occupational
therapist availability in Wales
Percentage of participants eligible from 70 43 Lower than originally expected because of

those approached primary referral pathways being different
from those expected
Percentage of participants randomised 50 95 Higher than originally expected because of

from those eligible primary referral pathways being different
from those expected
Percentage of participants randomised 35 41 Higher than originally expected
from those approached
Percentage of participants with missing 20 7 High levels of retention from trial participants
outcome data at 6 months post
randomisation
Contamination (usual-care participants N/A 0 No evidence of any contamination

accessing full SIT)
Adherence (number of SIT participants N/A 100 High levels of intervention receipt
receiving at least 13/20 intensive
sessions)
Fidelity (number of therapists scoring N/A Lower than expected. Assessing only
at least 80/100 for at least 80% of 15–20 minutes of each session may have
sessions rated) skewed this score, considering that the
global impression score for 23/24 sessions
reflected that the therapists intentionally
applied ASI intervention
N/A, not applicable.
Proposed modifications to design
Sample size implications

It would have been premature to use the SD and correlation estimates gathered at this time point
to make alterations to the target sample size (as prespecified and described in Aims and objectives).
Using a deflation factor of 1 – ρ2,76, Table 14 illustrates how the sample size could be reduced by
accounting for this correlation (fixing all other assumptions).
At the request of the Health Technology Assessment programme and as advised by the Independent Data
Monitoring and Ethics Committee, this correlation was revisited at two further time points: (1) when
primary outcome time point data were available for 38 participants (correlation between baseline and
6-month ABC-I scores 0.806, 95% CI 0.654 to 0.895) and (2) when outcome data were available for
53 participants (correlation between baseline and 6-month ABC-I scores 0.69, 95% CI 0.52 to 0.80).
This high level of correlation supported a reduction in the target sample size from 216 to 138 (a correlation
of ≥ 0.6 indicates a sample size of ≤ 138 with 90% power).
Discussion
Formal progression criteria relating to recruitment and retention were met. Although the proportion
of participants recruited via the various recruitment routes differed from that anticipated (i.e. there
43
TABLE 14 Required sample size accounting for correlation between baseline

and 6-month ABC-I scores
Correlation between baseline and

follow-up ABC-I Required sample size (n)
0 216
0.1 214
0.2 207
0.3 197
0.4 181
0.5 162
0.6 138
0.7 110
0.8 78
0.9 41
1 0
were more self-referrals and third-sector referrals) we did not encounter any difficulties in generating
expressions of interest. Given the large number of self-referrals, the proportion of those eligible from
initial expressions of interest was inevitably lower than anticipated. However, the proportion of those
participants randomised from those eligible was much higher than originally estimated.
We clearly demonstrated that the intervention was significantly different from usual care within trial
sites, and more widely within the NHS (see Chapter 2). Carer responses to the survey also suggested
that there is significant need and demand for additional occupational intervention for sensory difficulties.
There was no evidence of contamination, and all participants randomised to receive the intervention at
this point had received our prespecified minimum number of intensive sessions.
In terms of fidelity, the measure used to assess this has six contextual elements and four sensory–motor
factors addressing the child’s sensory–motor strengths and challenges (each element is rated on a scale
of 1–4, with 4 being ‘certainly, the therapist intentionally used this strategy’, 3 being ‘probably’, 2 being
‘doubtful’ and 1 being ‘no, the therapist did not use this strategy’). We stated that an independent
SIT-trained therapist would view 15–20 minutes of a session to determine fidelity. However, it is
possible that some of the fidelity elements may not have been present in the video clip selected.
This is particularly relevant when treating children with autism, as some of the elements of fidelity
(e.g. ‘collaborates in activity choice’, ‘challenges praxis and organisation of behaviour’) may be particularly
challenging to demonstrate without the assessor being privy to the goals and particular areas of
difficulty of the child. Therefore, we refined the fidelity protocol to explicitly define how fidelity was
recorded to ensure that it was reliable and consistent. This included using an additional assessor and
checking inter-rater reliability (see Chapter 8). Continued mentoring, as well as peer support, was also
in place to support fidelity adherence for treating therapists.
44

Chapter 5 Intervention
Overview: sensory integration therapy
Sensory integration therapy, as delivered in the SenITA trial, was consistent with manualised ASI and
established fidelity criteria.23,31,32 Participants allocated to the intervention arm received 26 1-hour
sessions of therapy, delivered over 26 weeks [i.e. two sessions per week for 10 weeks (intensive
phase), followed by two sessions per month for 8 weeks and then one telephone session per month
for 8 weeks (tailoring phase)]. An ‘effective’ dose for SIT had not been established prior to the current
trial. However, based on clinical experience and available evidence,13,33,34,80 attending 13 of a possible
20 sessions delivered during the intensive intervention phase (two-thirds) was felt likely to indicate
sufficient exposure.
A detailed assessment of sensory processing deficit was undertaken by treating therapists (i.e. SIPT54),
along with clinical observations post randomisation, to inform intervention planning (intervention
arm only). This detailed assessment facilitated the development of a hypothesis for each child as to the
nature of the underlying sensory difficulty affecting function. To further inform hypothesis development,
therapists were given access to participants’ scores on the SPM44 (which was used as a screening tool
to assess the level of SPD prior to enrolment in the trial; see Chapter 3). In addition to considering
background history (assessed via completion of an Occupational Profile assessment with carers30),
the COPM48 was conducted. This allowed the sensory–motor content of the SIT (i.e. proprioceptive,
vestibular or tactile) to be individualised to meet the specific sensory needs hypothesised to underlie
the functional goals of the participant. SIT uses the ‘just-right’ challenge for each child and therapy is
adjusted to functional ability (as assessed by therapists using the tools and measures described above,
prior to initiating treatment).
Carers were encouraged to observe or actively participate in sessions to facilitate engagement. Specific
sensory–motor activities to support their child’s sensory integration, guided by clinical assessment,
were discussed with carers to incorporate into family routines between sessions. Written guidelines
were included where appropriate. Success of these strategies was discussed at subsequent sessions.
A detailed intervention handbook was developed to guide therapists during intervention delivery and
a summary of key content is presented in this chapter.
Therapists
The intervention was delivered by 16 occupational therapists (typically NHS band 7) in regional clinics.
All therapists were trained in SIT with training meeting fidelity criteria (see Fidelity assessment tool).
Clinics were in localities covered by five university health boards in South Wales (i.e. Cardiff and
Vale, Aneurin Bevan, Cwm Taf Morgannwg, Swansea Bay and Hywel Dda) and two localities in
South England (i.e. Cornwall and North Buckinghamshire) (eight sites in total). Intervention therapists
were mentored prior to, and during, the trial by an independent sensory integration-trained therapist.
Intervention therapists provided therapy to participants randomised to the intervention arm only
(i.e. participants in the control arm who did have face-to-face contact with OT services were treated
by different therapists). However, most families in the control arm were not receiving direct OT input.
Where face-to-face therapy was provided as part of usual care, frequency of contact was typically less
than once per week and the intervention received did not meet SIT fidelity criteria.
45
INTERVENTION
Fidelity assessment tool
Fidelity of intervention delivery was assessed using the ASI intervention fidelity measure,23 which
included essential, structural and process fidelity elements. An independent fidelity assessor visited
sites in South Wales and an experienced therapist visited sites in South England and scored each site
for the essential element, according to level of therapist training/qualifications. Following this scoring,
a structural fidelity assessment was carried out, for which a minimum score of 85 out of 110 for the
following four areas was required: (1) safety of the environment; (2) assessment details and content of
therapist-held records, including therapist–carer collaboration in relation to goals set during therapy;
(3) physical space and equipment; and (4) communication with carers. In addition, the intervention
sessions were measured for process fidelity to determine whether or not the therapist ensured
physical safety; provided sensory opportunities; helped the child to maintain an appropriate level of
alertness; challenged postural, ocular, oral or bilateral motor control; challenged praxis and behavioural
organisation; collaborated in activity choice; tailored activity to provide appropriate challenge; ensured
activities were successful; supported intrinsic motivation to play; and established therapeutic alliance.
The scale demonstrates high content validity according to expert ratings and high reliability for process
elements (total score ICC 0.99; Crohnbach’s α = 0.99).23
Following provision of consent, face-to-face sessions were video-recorded. Fidelity of delivery was
discussed with mentors through viewing video-recorded face-to-face sessions delivered to a participant
for individual therapists early in the treatment series. A sample of recorded sessions in the intensive
phase were also rated for fidelity by independent sensory integration-trained therapists who had
successfully passed fidelity training (based on a randomly selected sample of the full sessions, of a
minimum of 15–20 minutes in duration). Demonstration of adequate fidelity of intervention delivery
was defined as scoring at least 80 out of 100 on the fidelity measure23 across at least 80% of sessions
sampled (see Chapter 8 for fidelity outcome data).
Fidelity principles
The key ingredients of the intervention can be described as the contextual elements that detailed the
interactive context between the therapist and the child, and the therapeutic alliance that occurred.
These elements delineated the playful and supportive atmosphere in which the intervention took
place and the strategies that ensured that the child’s motivation and interest were maintained
through play, that is, the ‘just-right’ challenge. Next, the specific sensory–motor therapeutic activities
that were individually tailored for each child were delineated. These activities were grouped into
four areas:
1. sensory perception (with special emphasis on tactile, proprioceptive and vestibular systems)
2. postural and ocular control and bilateral integration
3. praxis
4. sensory reactivity (with particular emphasis on hyper-reactivity to tactile, vestibular, visual and
auditory, and olfactory and gustatory sensation, and hyporeactivity to tactile, proprioceptive and
vestibular sensation).
These elements were dynamic, that is they did not necessarily occur in sequential order, but were fluid
and interacted with each other. The intervention involved systematic decision–making in the context
of a safe, playful, collaborative and therapeutic environment that focused on the ‘just-right’ challenge
and targeted the sensory and motor factors that facilitate skills and abilities needed for participation
in daily activities. These specific therapeutic activities were designed based on initial and ongoing
assessment data about the child and family, analysed in moment-to-moment interactions and interpreted
though the lens of knowledge and skills of the therapist.
46

Initial assessment
The initial assessment for participants randomised to the intervention arm was carried out over two sessions,
which were 1–2 hours in length and no more than 2 weeks apart. The assessment comprised the following.
Initial greeting and scene-setting

We began with an initial greeting, which involved scene-setting, a summary of the purpose of the study
and the intervention, and checking consent for recording of sessions.
Clinical observations
Unstructured observations, including descriptive assessment of level of arousal, postural control,
organisation of behaviour and motor planning ability, were carried out. In addition, a set of structured
observations based on sensory integration principles, covering an assessment of performance/difficulties
in proprioception, vestibular processing, motor planning and postural and ocular control, were carried
out. Specific guidelines on administration, interpretation and scoring were written in the intervention
handbook to ensure consistency between therapists.
The Sensory Integration and Praxis Test

The SIPT54 provides detailed information on the sensory processing and practice (i.e. motor planning)
abilities that underlie learning and behaviour, and facilitates identification of specific areas of difficulty.
There are 17 subtests that fall into four overlapping areas. The tests that are most closely associated
with each of the areas are as follows:
l motor-free visual perception (i.e. the ability to visually perceive and discriminate form and space
without involving motor co-ordination), including –
¢ space visualisation
¢ figure-ground perception.
l somatosensory perception (i.e. tactile, muscle and joint perception, encouraging the child to ‘feel’
rather than to ‘see’), including –
¢ manual form perception

¢ kinaesthesia
¢ finger identification
¢ graphesthesia
¢ localisation of tactile stimuli.
l praxis (i.e. the ability to motor plan in a range of ways), including –
¢ design copying
¢ postural praxis
¢ bilateral motor control
¢ praxis on verbal command
¢ constructional praxis
¢ motor accuracy
¢ sequencing praxis
¢ oral praxis.
l sensorimotor (i.e. sensory integration at multiple levels), including –
¢ standing/walking balance
¢ postrotary nystagmus.
47
INTERVENTION
Occupational profile
The occupational profile questions were given to the carer to complete between assessment sessions.
The occupational profile questions also included information about the child’s play preferences and
strengths, their school, their medical and developmental history, and infant and current behavioural
patterns. The therapist encouraged the carer to think of functional issues that were affecting their
child’s performance for discussion at the next session.
Sensory Processing Measure

The SPM44 was used as a screening measure to ensure a minimum level of SPD as an inclusion criterion.
The SPM provides eight standard scores for the following dimensions: (1) social participation, (2) vision,
(3) hearing, (4) touch, (5) body awareness (proprioception), (6) balance and motion (vestibular function),
(7) planning and ideas (praxis) and (8) a total sensory symptoms score. Scores on each of these dimensions
were classified as typical, some problems or definite dysfunction. For the purposes of the SenITA trial,
SPD was defined as either (1) a definite dysfunction on at least one sensory dimension (all domains except
social participation) and the total score or (2) at least a probable dysfunction on two or more sensory
dimensions and the total score. Treating therapists were able to access these scores to aid hypothesis
development and delivery of the intervention.
Canadian Occupational Performance Measure

The COPM48 is an individualised measure designed to detect change in a child’s (and carer’s)
self-perception of occupational performance over time. The COPM comprises the following four
key steps.
Problem definition
Defining the problem involved identifying occupational performance and participation problems.
Rating the importance of the identified participation challenge

Once problems were identified, the participant was asked to rate each activity in terms of its
importance in his or her life. Importance was rated on a 10-point scale. This process allowed the
child and/or carer to set intervention priorities and facilitated goal-setting and intervention planning
(note that the measure comprised pictorial rating scales and examples of childhood activities to
facilitate completion by children).
Selecting the main problem areas to target for intervention

Using the information above, the participant (or carer) chose up to five problems that were the most
pressing or important. If the child had capacity to be part of this process, the therapist chose areas
that were relevant to both the carer and the child. These identified problems formed the basis for the
intervention goals. An example script was provided to therapists for the COPM interview.
Contacting the carer to complete the Canadian Occupational Performance Measure

rating of performance and satisfaction with performance
Following completion of all other assessments and initial mentor discussions, carers were asked to rate
goals in terms of current performance and their satisfaction with this level of performance.
Interpretation of assessment
All assessment scores (i.e. SIPT, SPM and clinical observations) were interpreted using the ASI
Assessment® Interpretation Tool©. The ASI Assessment Interpretation Tool is intended for use in
conjunction with the instructional information provided in the clinician’s guide for implementing ASI30
and in specialised ASI training programmes (adapted for the SenITA trial by Kath Smith and SD).
48

Hypothesis development
Using the assessment data as indicated on the interpretation tool, therapists developed a hypothesis
about which areas of dysfunction were particularly influencing the child’s performance and participation.
Goal development
Therapists were encouraged to use the FEAST (Functional, Expectation, Action, Specific condition,
Timeline) model to assist in articulating the specific goals identified by the child/carer in the COPM.
The functional element asks ‘why’ a goal is required (i.e. the area of occupation to be addressed, such
as to dress himself/herself). The expectation element specifies ‘who’ (i.e. ‘X will . . . ’). The action element
looks at ‘what’ is to be undertaken (e.g. ‘X will put his/her shirt and shorts on’). The specific condition
element considers ‘how’ this will be carried out (e.g. with three verbal prompts once the clothes have
been laid out). Finally, the timeline element considers ‘when’ this will be carried out (e.g. by the end
of session 24).
Summary of strengths, participation challenges and goals

The child’s strengths were summarised from the occupational profile and discussion with the carer.
Participation challenges were summarised from the occupational profile and carer discussion.
Therapists then produced a summary of their interpretation of the assessment results. From the
assessment results and hypothesis of underlying difficulties, the therapist selected specific SIPT
items and clinical observations to reassess at the end of therapy (proximal outcomes), in addition
to the child or carer re-rating their performance and satisfaction with their goals on the COPM
(distal outcomes).
Mentoring
All therapists were assigned a mentor. Mentors were senior occupational therapists who were fully
trained and experienced in the delivery of SIT (note that a separate pool of independent and sensory
integration-trained therapists rated sessions for fidelity, as described in Chapter 5). Therapists discussed
the first two sessions that they delivered with mentors to confirm their hypothesis and direction of
therapy. Fidelity of delivery was discussed with mentors early in the series of treatment, once rapport
between the child and the therapist was established, to support therapists. Mentoring sessions of
approximately 1 hour in length were provided monthly (or more often within the first 2 months of the
intervention delivery phase if the therapist requested this), tapering to once per month or at least once
every 6 weeks thereafter. A Facebook (Meta Platforms, Inc., Menlo Park, CA, USA; www.facebook.com)
group was also set up for treating therapists and mentors to join, should they wish; 17 members used
this facility. This was a forum for therapists to support each other in the trial and to share ideas. The group
was active throughout the trial, although not all participants contributed. In addition, all therapists had a
joint training session (including fidelity training) at the start of the trial before recruitment of participants.
This was followed by a 2-hour individual therapist training session to confirm the therapy protocol and
explain the detail in the intervention handbook, followed by an additional training session on saving and
uploading data. Further support was offered during the trial, including two face-to-face half-day events to
share ideas, challenges and solutions.
Following assessment and interpretation, therapists were encouraged to contact their mentor. Mentors
were given access to a shared folder that allowed therapists to share specific information with them,
including SIPT scores (uploaded by the research team), interpretation summaries, assessment videos
(where available) and the summary of participation strengths, challenges, goals and hypotheses.
Mentors were also able to access SPM data and clinical observations as required. Therapists were
given detailed guidance on how to share information with mentors, and discussed hypotheses and
goals with them, allowing any changes to goals or hypotheses to be made at this stage, before
contacting the carer to complete the COPM rating of performance and satisfaction.
49
INTERVENTION
Mentors were given a manual that detailed key elements of the study, therapist requirements and
expected timelines for mentoring sessions. Although therapists were all trained in SIT, most therapists
carried a varied caseload of children with a range of difficulties and, therefore, would typically use a
range of treatment approaches. Therefore, a list of watch points/common errors was also provided to
mentors, which included the following:
l Therapists may need to break eclectic habits (as this was a research study of SIT and not a standard
NHS intervention).
l Therapists may find it difficult to swap from therapist- to child-directed play.
l Therapists may not be used to treating for this many sessions. Therefore, therapists may be anxious
by sessions 7 or 8 and may need support to continue to challenge their participant. Grading will
become increasingly important and experience indicates that changes start to occur by about weeks
8–10 and, therefore, therapists are encouraged to keep going.
l Therapists may need support to be playful, as this may not be the style of their traditional therapy.
l Therapists may need reminders that they should not work only on modulation. Praxis may be quite
markedly poor and overlooked with other concerns taking precedence.
l Therapists should keep data and hypotheses in mind for each session.
Intervention session content
A brief outline of session content is given below.
Session 1
Key steps and activities were as follows:
l Goals and hypotheses for underlying sensory–motor difficulties were checked prior to the session.
l The room was set up with provisional equipment and toys that were in keeping with hypothesis
from assessment data, considering strengths, challenges and needs.
l The video camera was checked and switched on.
l Carer and participant were greeted. The child was made comfortable with a simple explanation of
the activities that they would be doing and how these games would help them.
l The therapist used their professional and clinical reasoning to apply each of the ASI fidelity
principles to ensure that the challenges were appropriate for the child’s age, ability levels
and needs.
l The carer was encouraged to participate in the session or to watch as they felt comfortable.
The level of carer engagement was negotiated with the carer during the telephone call (see Fidelity
assessment tool).
l There was no set sequence, manner or format for incorporating all of the key principles and implementing
tailored activities. However, the flow of the session could be divided into three phases of beginning,
middle and end. Sessions lasted about 50–55 minutes, including 5–10 minutes to have a short discussion
with the carer about activities or strategies to try at home. Advice sheets may have been given at this
point, if appropriate.
Beginning of the session

At the first session, therapists had all information about the child from the assessment, including the
hypothesis of underlying sensory motor difficulties. In addition, therapists had formulated a plan of
activities that could help facilitate these areas. As the child arrived, the therapist was usually able to
form an impression in the moment as to their mood and state. This initial impression paired with the
knowledge of the child determined what happened at the beginning of the session. Given that therapeutic
alliance and prioritisation of the context of play are so important, the tone set at the beginning of the
session was key, as the child may have needed time to get organised and feel comfortable.
50

Middle of the session

The middle part of the session was generally when sensory–motor factors underlying the child’s main
participation strengths and challenges were addressed. For example, if a child liked dinosaurs but had
tactile perception difficulties, the therapist could hide dinosaurs in places that incorporated a tactile
element. The full range of fidelity elements (see Fidelity assessment tool) needed to be considered
throughout to ensure that that playful activities were utilised within the ‘just-right’ challenge level.
Levels of adaptive responses (Table 15) were used when determining the ‘just-right’ challenge for
sensory–motor activities and the level of functioning within the capacity of the child.
The affordances of different pieces of equipment needed to be considered (e.g. a platform swing could
be used in sitting in a linear direction, or prone lying and rotating, or even in an orbital arc while
upright kneeling). The therapy required creative flexible thinking and clinical reasoning informed by
the underpinning goals.
End of the session

At the end of the session, the therapist would help the child to be ready to transition out of the
intervention setting. Some children who become very engaged in the fun and meaningful intervention
activity may be sad to see the session finish and may protest fiercely; therefore the therapist would
monitor the child’s state of arousal, activity level and emotional state to help the child be ready to
leave. This could involve engaging the child in putting heavy therapy equipment away and helping them
to be calm and organised while creating a natural sense of closure. Likewise, therapists would help
children to orient to cues, such as a clock or last steps for completion of an activity. If a child was due
to return (i.e. for future sessions) then therapists would talk about what might happen ‘next time’.
Reflective questions for each session were completed.
Contact with school

On some occasions, it was appropriate to contact the school to get additional feedback on the
child’s participation and to give verbal advice if there were sensory–motor challenges that needed
to be addressed. This advice may include sensory–motor activities that had been effective within
the intervention that could be applied within the school context (e.g. if the child calmed after using
proprioceptive activities, the therapist may suggest that the teacher incorporates activities that
demand muscle work, such as playing with weighted balls). Any contact with the school was recorded
in the intervention notes.
Intervention sessions 2–20

Intervention sessions 2–20 continued as with session 1 above and included a review of any activities
carried out since the last session with the carer.
TABLE 15 Levels of adaptive responses
Level Adaptive response
1 Responds to passive stimuli
2 Holding on and staying put
3 Alternating contracting/relaxing muscle groups
4 Initiating an activity, but not completing it independently
5 Moving independently in a somewhat familiar pattern

6 Moving through the environment in an unfamiliar way
7 Performing complicated activities using unfamiliar movement
51
INTERVENTION
Intervention sessions 21–23

After the twice-weekly intense phase of therapy, instead of sessions ceasing altogether, a tailoring
phase of therapy sessions once per fortnight was delivered and continued with planning as previously
detailed in Intervention session content, Session 1, Beginning of the session. This was designed to aid
transition from therapist-directed intervention to carer-supported management of the child, and
provided an opportunity to discuss any issues that arose to jointly think of solutions.
Intervention session 24
For session 24, the SIPT or clinical observation items identified as proximal outcome measures were
reassessed. The COPM was re-administered to determine how the carer (and the child if they had
capacity to do this) initially rated the five goals for performance and satisfaction with that performance.
The therapist then explained to the participant that there would be two follow-up telephone calls to
monitor progress and to problem-solve any issues that might arise. Strategies and advice for continuing
the progress made during the face-to-face sessions were discussed.
Session 25 comprised a telephone call, which was carried out 1 month following the last intervention
session. The purpose of the telephone call was to:
l follow up on the child’s performance and behaviour in the past month

l determine whether or not any advice and strategies previously given were successful
l offer support and advice for any ongoing issues.
Possible prompt questions were provided to therapists to discuss with participants.
Session 26 was the same as session 25, but with the additional purpose of closure, as this was the final
contact with the carer. The purpose of this telephone call was twofold. First, to follow up (as in the
previous telephone call) and discuss any changes to behaviour and to determine whether or not any
advice and strategies were carried out. Second, to consider the goals chosen at the beginning of
therapy and informally discuss the progress of the child, and, finally, to thank the carer for their
engagement in the process (prompt questions were provided to be used as needed).
A brief written summary of the intervention was provided to carers/schools if requested. The summary
did not include the outcome of intervention, as this was not appropriate within the research trial;
however, it did include the goals that were set prior to intervention, including the specific target
areas that were concentrated on.
Information regarding fidelity of intervention delivery, participant adherence and therapist experience
of therapy and of trial participation is provided in Chapter 8.
52

Chapter 6 Quantitative results
Recruitment and participant flow
Between August 2017 and June 2020, we screened 150 individuals, of whom 142 (94.7%) were
eligible and consented. Of the 142 consented participants, 138 (97.2%) were randomised. Of those
randomised, 107 (77.5%) provided data at 6 months post randomisation. Two participants withdrew
from the study prior to this time point and 29 participants were lost to follow-up. Data were provided
at 12 months post randomisation by 96 (69.6%) participants. There were no further withdrawals
between 6 and 12 months, but 40 participants were lost to follow-up (Figure 5).
Expression of interest
(n = 258)
Not screened
(n = 108)
• No further responses, n = 61
• Not eligible at referral, n = 24
• Not interested in participating, n = 23
Baseline
Referral and screening
(n = 150)
Excluded
(n = 12)
• No further response, n = 4
• Not meeting inclusion criteria, n = 3
• Not interested in participating, n = 1
• Recruited but withdrew, n = 4
Randomised
(n = 138)
Allocated to SIT programme Allocated to usual care

(n = 69) (n = 69)
Follow-up
• Lost to follow-up, n = 29
• Discontinued study, n = 2 6 months after randomisation
(n = 107)
Follow-up
• Lost to follow-up, n = 40
12 months after randomisation • Discontinued study, n = 2
(n = 96)
FIGURE 5 A CONSORT (Consolidated Standards of Reporting Trials) flow diagram.
53
QUANTITATIVE RESULTS
Baseline characteristics
Participant characteristics at baseline were reasonably well balanced between trial arms. Differences
of note were present for the sex of child [i.e. male participants represented 57/69 (82.6%) control
arm participants vs. 52/69 (75.4%) intervention arm participants], statement status [27/69 (39.1%)
participants had a statement in the control arm vs. 32/69 (46.4%) participants in the intervention arm]
and EuroQol visual analogue scale (EQ-VAS) [the control arm had a median EQ-VAS score of 80
(IQR 70–87) vs. a median EQ-VAS score of 75 (IQR 70–80) in the intervention arm].
Overall, participants had a mean age of 7.87 (SD 1.73) years, 99 out of 138 (71.7%) participants were
recruited from South Wales and, based on their SPM results, 107 out of 138 (77.5%) had scores
indicative of ‘definitive dysfunction’ (Table 16).
Autism Diagnostic Observation Schedule assessments were carried out at baseline to characterise
the sample in terms of autism symptoms, but not as a diagnostic measure. A summary is presented in
Table 17 for each assessment module spilt by arm. Data are presented for 135 out of 138 participants.
It was not possible to obtain ADOS scores for three participants who were unable to engage with this
aspect of the assessment process.
TABLE 16 Baseline characteristics
Study arm
Control Intervention All participants

Characteristic (n = 69) (n = 69) (n = 138)
Age (years), mean (SD) 7.77 (1.76) 7.97 (1.72) 7.87 (1.73)
Sex of child, n (%)
Male 57 (83) 52 (75) 109 (79)
Female 12 (17) 17 (25) 29 (21)
Region, n (%)
South Wales 51 (74) 48 (70) 99 (72)
South England 18 (26) 21 (30) 39 (28)

Site, n (%)
Aneurin Bevan 5 (7) 7 (10) 12 (9)
Cardiff and Vale 24 (35) 21 (30) 45 (33)

a
Cornwall 11 (16) 11 (16) 22 (16)
Cwm Taf 8 (12) 6 (9) 14 (10)
Hywel Dda 10 (14) 10 (14) 20 (14)
Pace Centrea 7 (10) 10 (14) 17 (12)
Swansea Bay 4 (6) 4 (6) 8 (6)

b
Ethnicity, n (%)
White British 41 (84) 50 (93) 91 (88)
Asian/Asian British: Indian 2 (4) 0 (0) 2 (2)
Mixed/multiple ethnic groups: 2 (4) 0 (0) 2 (2)

white and black Caribbean
Other 4 (8) 4 (7) 8 (8)
54

TABLE 16 Baseline characteristics (continued )
Study arm
Control Intervention All participants

Characteristic (n = 69) (n = 69) (n = 138)
Type of school attended, n (%)
Mainstream (full time) 47 (70) 55 (83) 102 (77)
SRB (full time) 4 (6) 5 (8) 9 (7)
Mainstream and SRB 4 (6) 3 (5) 7 (5)
Special school (day) 1 (1) 0 (0) 1 (1)

PRU 1 (1) 0 (0) 1 (1)
Other 10 (15) 3 (5) 13 (10)
Statement status, n (%)
Yes 27 (39) 32 (46) 59 (43)
No 39 (57) 33 (48) 72 (52)
Not sure 3 (4) 4 (6) 7 (5)

c
Cormorbidity, n (%)
Yes 22 (45) 28 (48) 50 (47)
No 27 (55) 30 (52) 57 (53)
Number of comorbidities if answered ‘yes’, n
1 18 20 38
2 4 7 11
3 1 1
ADHD, n (%)
Yes 10 (20) 17 (29) 27 (25)
No 39 (80) 41 (71) 80 (75)
ID, n (%)
Yes 4 (8) 11 (19) 15 (14)
No 45 (92) 47 (81) 92 (86)
Other neurodevelopmental/genetic, n (%)
Yes 12 (24) 9 (16) 21 (20)

No 37 (76) 49 (84) 86 (80)
SPM, n (%)
Some problems 16 (23) 15 (22) 31 (22)
Definite dysfunction 53 (77) 54 (78) 107 (78)

SRB, specialist resource base; PRU, pupil referral unit.
a South England sites.
b Missing for 20 control participants and 15 intervention participants.
c Comorbidities of interest are ADHD, ID or other neurodevelopmental/genetic conditions. Missing for 20 control
participants and 11 intervention participants.
55
56
TABLE 17 Summary of baseline ADOS scores by trial arm
Module 3, n (%) Module 2, n (%) Module 1, n (%)
Control Intervention Total Control Intervention Total Control Intervention Total

Social effect (N = 59) (N = 57) (N = 116) (N = 5) (N = 8) (N = 13) (N = 4) (N = 2) (N = 6)
Communication Three items: maximum score = 6 Two items: maximum score = 4 Three items: maximum score = 6
Scored 2 on all items (100%) 11 (18.6) 6 (10.5) 17 (14.7) 2 (40) 1 (12.5) 3 (23.1) 2 (50) 2 (100) 4 (66.7)
Scored 2 on 50–99% of items 23 (38.9) 27 (47.4) 50 (43.1) 2 (40) 6 (75) 8 (61.5) 1 (25) 0 (0) 1 (16.7)
Scored 2 on < 50% of items 25 (42.4) 24 (42.1) 49 (42.2) 1 (20) 1 (12.5) 2 (15.4) 1 (25) 0 (0) 1 (16.7)
Reciprocal social interaction Seven items: maximum score = 14 Eight items: maximum score = 16 Eight items: maximum score = 16
Scored 2 on all items (100%) 2 (3.4) 2 (3.5) 4 (3.4) 0 (0) 2 (25) 2 (15.4) 0 (0) 0 (0) 0 (0)
Scored 2 on 50–99% of items 25 (42.4) 21 (36.8) 46 (39.7) 4 (80) 3 (37.5) 7 (53.8) 2 (50) 2 (100) 4 (66.7)
Scored 2 on < 50% of items 32 (54.2) 34 (59.6) 66 (56.9) 1 (20) 3 (37.5) 4 (30.8) 2 (50) 0 (0) 2 (33.3)
Restricted and repetitive Four items: maximum score = 8 Four items: maximum score = 8 Four items: maximum score = 8
behaviours
Scored 2 on all items (100%) 2 (3.4) 1 (1.75) 3 (2.6) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
Scored 2 on 50–99% of items 12 (20.3) 7 (12.3) 19 (16.4) 3 (60) 3 (37.5) 6 (46.2) 0 (0) 1 (50) 1 (16.7)
Scored 2 on < 50% of items 45 (76.3) 49 (85.9) 94 (81) 2 (40) 5 (62.5) 7 (53.8) 3 1 (50) 5 (83.3)
Average scores on clinical measures at baseline were generally within the middle of the score range,
with exceptions being for ABC lethargy/social withdrawal (lower end of the scale, indicating lower
levels of lethargy/social withdrawal), ABC stereotypic behaviour (lower end of the scale, indicating
lower levels of stereotypic behaviour) and EQ-5D (higher end of the scale, indicating higher levels
of health utility and quality of life). However, the range of scores spanned most of the scale for all
measures (see Tables 19 and 20).
Intervention receipt and fidelity
Initiation of sensory integration therapy

Of the 69 participants randomised to the intervention arm, 61 (88.4%) initiated SIT and 49 out of
57 (86.0%) initiated prior to their primary outcome follow-up. In those who initiated SIT, the median
time from randomisation to initiation was 48 (IQR 32–85) days (Figure 6).
Implementation of sensory integration therapy

Overall, 54 (78.3%) participants allocated to the intervention arm received at least 13 SIT sessions
during the intensive stage, with 38 out of 57 (66.7%) participants with primary outcome follow-up
data receiving at least 13 SIT sessions during the intensive stage. The median number of SIT sessions
received was 20 (IQR 16–21) and the median number of SIT sessions received prior to primary outcome
follow-up (in those with primary outcome data) was 18 (IQR 10–21).
Receipt of SIT sessions varied considerably between participants. Figure 7 highlights different patterns
of SIT session receipt for six participants, with Table 18 providing summary statistics for each
participant. Participants A, B and C display typical patterns of participants who initiated SIT early
(i.e. between 20 and 48 days post randomisation) and attended most of their sessions. Participant A
received two SIT sessions after their primary outcome data were collected. Participant D initiated SIT
late (i.e. at 119 days post randomisation) and shows a typical pattern of someone who attended most
of their sessions, but received a substantial number of them after their primary outcome data were
collected. Participant E displays a pattern of someone who started SIT but who stopped early on.
Participant F is a participant who started SIT 348 days post randomisation and, therefore, all sessions
received were after collection of their primary outcome data.
1.00
0.90
Proportion of individuals initiating SIT
0.80
0.70
0.60
0.50
0.40
0.30
0.20
0.10
0.00
0 25 50 75 100 125 150 175 200 225 250 275 300 325 350
Time from randomisation to initiation of SIT (days)a
FIGURE 6 Time from randomisation to initiation of SIT in days (for the 61 participants allocated to and initiating SIT).
a, Figure includes 61 out of 69 participants who initiated SIT.
57
(a)
Attended session
Session attended prior
to 6-month follow-up
Session attended following
6-month follow-up
0 100 200 300 400 500

Time since randomisation (days)
(b)
Attended session

6-month follow-up
0 100 200 300 400 500

(c)
Attended session

6-month follow-up
0 100 200 300 400 500

(d)
Attended session

6-month follow-up
0 100 200 300 400 500

FIGURE 7 Panel plot of session attendance for six different participants. (a) Participant A; (b) participant B; (c) participant C;
(d) participant D; (e) participant E; and (f) participant F. (continued )
58

(e)
Attended session
6-month follow-up
0 100 200 300 400 500

(f)
Attended session

6-month follow-up
0 100 200 300 400 500

FIGURE 7 Panel plot of session attendance for six different participants. (a) Participant A; (b) participant B; (c) participant C;
(d) participant D; (e) participant E; and (f) participant F.
TABLE 18 Descriptive statistics of SIT implementation for six participants
Days from randomisation Number of sessions Number of sessions attended

Participant to initiation of SIT attended in total prior to 6-month follow-up
A 48 22 20
B 29 21 21
C 20 19 19
D 119 23 13
E 85 8 8
F 348 21 0
Outcome variables are summarised in Tables 19 and 20 at baseline and at 6 and 12 months post
randomisation. For the primary outcome (i.e. ABC-I), Figure 8 illustrates baseline and 6-month scores by
study site.
Our primary analysis included 106 participants. At 6 months post randomisation, the mean ABC-I score
was 18.8 (SD 10.48) in the control arm and 18.5 (SD 9.33) in the intervention arm. The correlation
between baseline and 6-month ABC-I score was 0.698 (95% CI 0.585 to 0.784). After adjusting for
baseline ABC-I, sex of child, SPM category and region, the between-arm difference was 0.40 points
higher in the intervention arm than in the control arm (95% CI –2.33 to 3.14; p = 0.77) (Table 21).
59
TABLE 19 Baseline scores by arm
Study arm
Intervention Control
Measure n Mean (SD) Range n Mean (SD) Range
ABC (higher scores reflect higher levels of behaviour/worse outcome)
ABC-I: range 0–45 69 21.20 (9.22) 2–42 69 21.09 (9.64) 1–42
ABC-W: range 0–48 69 15.41 (7.64) 3–41 69 13.67 (7.55) 1–37
ABC-S: range 0–21 69 7.55 (4.83) 0–21 69 7.62 (5.07) 0–21
ABC-H: range 0–48 69 26.90 (9.70) 5–45 69 27.49 (10.73) 7–48
ABC-IS: range 0–12 69 5.14 (2.85) 0–12 69 5.38 (3.27) 0–12

VABS (standardised, mean 100)
Composite score 57 65 (6.31) 49–82 62 66 (5.21) 54–84
VABS domain
Communication 66 72 (10.32) 49–100 66 71 (6.61) 59–95
Daily living skills 64 63 (6.57) 46–79 65 63 (8.44) 28–89
Socialisation 61 65 (7.75) 51–85 63 65 (6.62) 51–81
APSI: range 0–65 (higher score indicates 69 24.59 (10.03) 3–48 69 24.43 (9.10) 8–49
more stress)
EQ-5D-5L
EQ-VAS: range from 0 (worst health) 69 75 (70–80)a 20–100 69 80 (70–87)a 9–100

to 100 (best health)
Index value: range from –0.28 to 1 69 0.77 (0.72–0.88)a 0.15–1 69 0.84 (0.74–0.88)a –0.27–1
(higher score indicates better health)
CarerQoL (higher score reflects better care situation)
CarerQol-7D: range 0–14 69 7.77 (2.43) 3–13 69 8.09 (2.42) 1–14
CarerQol-VAS: range 0–10 69 6.63 (1.43) 3–10 69 6.60 (1.74) 2–10

ABC-H, Aberrant Behavior Checklist – hyperactivity/non-compliance; ABC-IS, Aberrant Behavior Checklist –
inappropriate speech; ABC-S, Aberrant Behavior Checklist – stereotypic behaviour; ABC-W, Aberrant Behavior
Checklist – lethargy/social withdrawal.
a Values in brackets are IQRs.
Note
Control arm, n = 69; intervention arm, n = 69; all participants, n = 138.
Secondary analysis of primary outcome
Accounting for repeated measures over time, the between-arm difference was 0.61 points lower in
the intervention arm than in the control arm (95% CI –3.13 to 1.92; p = 0.64). The conclusions drawn
from our primary analysis were also unaffected by sensitivity analyses accounting for missing data
(see Table 28), intervention receipt (see Table 28) or the COVID-19 pandemic (see Table 27).
At 12 months post randomisation, an ABC-I score was available for 96 participants. The mean ABC-I
score was 19.9 (SD 11.19) in the control arm and 17.7 (SD 9.33) in the intervention arm. After
adjusting for baseline ABC-I, sex of child, SPM category and region, the between-arm difference was
2.01 points lower in the intervention arm than in the control arm (95% CI –5.38 to 1.36; p = 0.24).
60

DOI: 10.3310/TQGE0020
TABLE 20 Outcome scores at 6 and 12 months
6 months 12 months
Intervention Control Intervention Control
Measure n Mean (SD) Range n Mean (SD) Range n Mean (SD) Range n Mean (SD) Range
ABC (higher scores reflect higher levels of behaviour/worse outcome)
ABC-I: range 0–45 57 18.54a (9.33) 1–43 49 18.82a (10.48) 1–39 52 17.69 (9.00) 0–37 44 19.93 (11.19) 1–43
ABC-W: range 0–48 49 12.35 (8.09) 2–34 36 11.61 (5.93) 0–25 36 14 (7.75) 1–31 24 12.71 (6.52) 1–28
ABC-S: range 0–21 49 5.71 (4.45) 0–18 36 5.94 (4.60) 0–17 36 6.31 (4.40) 0–17 24 5.50 (3.97) 0–16
ABC-H: range 0–48 49 22.76 (9.42) 8–41 36 24.58 (11.71) 1–46 36 23.06 (10.59) 5–45 24 25.46 (11.84) 4–46
ABC-IS: range 0–12 49 4.51 (2.80) 0–12 36 4.81 (3.56) 0–12 36 5.17 (2.80) 1–12 24 5.25 (3.29) 0–11
Health Technology Assessment 2022 Vol. 26 No. 29

ABC-I (teacher assessed): 25 9.60 (10.06) 0–35 19 10.48 (9.48) 0–34 Not Not
range 0–45 measured measured
VABS (standardised, mean 100)
Composite 39 67 (6.52) 44–85 31 67 (6.52) 57–85 22 64 (5.59) 55–78 14 65 (4.96) 55–71
Domain
Communication 42 73 (8.99) 57–100 32 72 (7.08) 61–85 24 70 (9.51) 52–93 16 72 (7.67) 59–87
Daily living skills 42 62 (8.06) 27–75 32 64 (6.44) 54–83 24 62 (5.75) 48–73 15 62 (4.25) 52–68
Socialisation 39 68 (6.87) 51–85 31 68 (10.63) 55–96 22 65 (7.28) 51–78 16 64 (8.62) 51–81
continued
61
62
TABLE 20 Outcome scores at 6 and 12 months (continued )
6 months 12 months
Intervention Control Intervention Control
Measure n Mean (SD) Range n Mean (SD) Range n Mean (SD) Range n Mean (SD) Range
APSI: range 0–65 (higher score 48 20.08 (8.11) 4–37 35 20.14 (8.91) 0–40 36 21.17 (8.76) 8–42 24 20.88 (8.79) 6–36
indicates more stress)
EQ-5D-5L
EQ-VAS: range from 0 (worst 48 75 (70–80)b 7–96 35 80 (75–85)b 50–100 36 72.5 (60, 82.5) 10–90 24 80 (65, 87.5) 45–95
health) to 100 (best health)
Index value: range from –0.28 48 0.77 (0.74–0.88)b 0.17–1 35 0.84 (0.73–0.88)b 0.17–1 36 0.84 (0.71, 0.88) –0.19–1 24 0.78 (0.69, 0.88) 0.11–1
to 1 (higher values indicate
better health)
CarerQoL (higher score reflects better care situation)
CarerQol-7D: range 0–14 48 8.02 (2.43) 3–12 35 8.31 (2.60) 3–13 36 7.67 (2.57) 2–12 24 7.63 (2.99) 3–13
CarerQol-VAS: range 0–10 48 6.71 (1.79) 2–10 35 7.15 (1.24) 5–9.3 36 6.60 (1.35) 2–10 24 7.08 (1.14) 5–9
ABC-H, Aberrant Behavior Checklist – hyperactivity/non-compliance; ABC-IS, Aberrant Behavior Checklist – inappropriate speech; ABC-S, Aberrant Behavior Checklist – stereotypic
behaviour; ABC-W, Aberrant Behavior Checklist – lethargy/social withdrawal.
a Primary outcome.
b Values in brackets are IQRs.
Baseline: control arm mean = 13.00

(a) Baseline: intervention arm mean = 23.86
6 months: control arm mean = 16.20
6 months: intervention arm mean = 21.29
40
ABC-I score at 6 months

30
Control
20 Intervention
10
0
0 10 20 30 40
ABC-I score at baseline
(b)
40 Baseline: intervention arm mean = 17.05

30
Control
20 Intervention
10
0
0 10 20 30 40
(c)
40
Baseline: intervention arm mean = 18.00

30
Control
20 Intervention
10
0
0 10 20 30 40
(d)

30
Control
20 Intervention
10
0
0 10 20 30 40
FIGURE 8 ABC-I scores at baseline and 6 months, by site. (a) Site 1, Aneurin Bevan; (b) site 2, Cardiff and Vale; (c) site 3,
Cornwall; (d) site 4, Cwm Taf; (e) site 5, Hywel Dda; (f) site 6, Pace Centre; and (g) site 7, Swansea Bay. (continued )
63
(e)
40

Baseline: intervention arm mean = 21.60
30
Control
20 Intervention
10
0
0 10 20 30 40
(f)

30
Control
20 Intervention
10
0
0 10 20 30 40
(g)

30
Control
20 Intervention
10
0
0 10 20 30 40
FIGURE 8 ABC-I scores at baseline and 6 months, by site. (a) Site 1, Aneurin Bevan; (b) site 2, Cardiff and Vale; (c) site 3,
Cornwall; (d) site 4, Cwm Taf; (e) site 5, Hywel Dda; (f) site 6, Pace Centre; and (g) site 7, Swansea Bay.
Secondary outcomes
Behavioural measures
At 6 months post randomisation, secondary outcomes relating to behaviour were available for
85 participants. There was no evidence of any differences between arms across the lethargy/social
withdrawal, stereotypic behaviour, hyperactivity or inappropriate speech domains of the ABC
(see Table 21).
64

TABLE 21 Regression analysis comparing the intervention arm with the control arm, adjusting for baseline score, sex of
child, SPM category and region: 6 months
Measure n Estimate 95% CI p-value
ABC score
ABC-I 106 0.40 –2.33 to 3.14 0.77
ABC-W 85 –0.45 –2.73 to 1.84 0.70
ABC-S 85 –0.22 –1.60 to 1.16 0.75
ABC-H 85 –0.19 –3.32 to 2.95 0.91
ABC-IS 85 –0.23 –1.29 to 0.82 0.66
VABS
Composite 63 –0.17 –2.74 to 2.40 0.90

Communication 72 1.02 –1.54 to 3.59 0.42
Daily living skills 71 –2.06 –5.12 to 0.99 0.18
Socialisation 65 –0.63 –3.91 to 2.66 0.71
APSI 83 0.17 –2.96 to 3.30 0.91
EQ-5D-5L
EQ-VAS 83 –4.18 –10.73 to 2.37 0.21
Index value 83 0.01 –0.06 to 0.08 0.71

CarerQol
CarerQol-7D 83 –0.07 –0.93 to 0.79 0.87
CarerQol-VAS 83 –0.38 –0.98 to 0.20 0.19

At 12 months post randomisation, secondary outcomes relating to behaviour were available for
60 participants. Similarly, we found no evidence of any differences between arms across these
measures (Table 22).
Adaptive behaviour measures

The analysis of adaptive behaviour measures at 6 months included between 63 and 72 participants.
For the composite measure and communication, socialisation and daily living skills domains, there was
no evidence of any differences between arms (see Table 20). At 12 months, the communication domain
score was 5.69 points lower in the intervention arm than in the control arm (95% CI –9.87 to –1.51;
p = 0.009). There was no evidence of any differences between arms for the composite measure or
other domains (see Table 20).
However, an error in administration of this measure for the majority of participants meant that we had
introduced an artificial ceiling effect and scores were potentially less sensitive to change. Start points
of each subdomain depend on the child’s chronological age, and age ranges are given as indicators of
where performance might be expected to lie. Indicative upper limits are not intended to be used as
cut-off points during administration, but were, for most participants, potentially limiting the magnitude
of change that could be observed. It is uncertain whether or not this error masked any differences
65
TABLE 22 Regression analysis comparing the intervention group with the control group, adjusting for baseline score,
sex of child, SPM category and region: 12 months
Measure n Estimate 95% CI p-value
ABC score
ABC-I 96 –2.01 –5.38 to 1.36 0.24
ABC-W 60 0.78 –2.49 to 4.04 0.64

ABC-S 60 0.08 –1.86 to 2.03 0.93
ABC-H 60 –1.46 –6.09 to 3.17 0.52
ABC-IS 60 0.10 –1.26 to 1.47 0.88
VABS
Composite 32 –0.90 –4.01 to 2.21 0.56
Communication 39 –5.69 –9.87 to –1.51 0.009
Daily living skills 37 –0.46 –3.07 to 2.15 0.72

Socialisation 35 0.15 –4.55 to 4.85 0.95
APSI 60 0.49 –3.47 to 4.46 0.81
EQ-5D-5L
EQ-VAS 60 –5.29 –14.03 to 3.45 0.23
Index value 60 0.03 –0.07 to 0.13 0.60
CarerQol
CarerQol-7D 60 0.16 –1.03 to 1.35 0.79

CarerQol-VAS 60 –0.31 –0.92 to 0.31 0.32
between arms with regard to adaptive behaviour domains. However, given the absence of any marginal
effects (excepting a negative effect on communication at 12 months, which may also be reflective of
multiple testing) and an absence of effect across other outcomes, this is perhaps unlikely.
Parenting stress
At 6 months, APSI scores were available for 83 participants. We found no evidence of between-arm
differences for this measure. Similarly, we found no evidence of between-arm differences at 12 months.
Health utility and quality of life

At 6 months, EQ-5D and CarerQoL scores were available for 83 participants. Similar to other
outcomes, we found no evidence of any differences between arms with regard to health utility, generic
health-related quality of life or carer quality of life (see Table 20). Similarly, we found no evidence of
between-arm differences at 12 months (see Table 20).
Teacher-assessed Aberrant Behavior Checklist – irritability

The mean of the difference between carer- and teacher-assessed ABC-I at 6 months was 10.28
(SD 14.48), with a 95% limit of agreement of –18.12 to 38.68. There was strong evidence of difference
between the two measures (p < 0.001), indicating that, on average, carer-assessed ABC-I scores were
higher (Figure 9).
66

40
teacher-assessed ABC-I) at 6 months

Difference (carer-assessed ABC-I –
30
20
10
–10
–20
–30
–40
0 10 20 30 40
Average of carer-assessed ABC-I and
teacher-assessed ABC-I at 6 months
FIGURE 9 Carer- and teacher-assessed ABC-I. Mean difference of 10.28; 95% limits of agreement of –18.12 to 38.68.
Canadian Occupational Performance Measure

Carer-rated goal performance and satisfaction were available for 43 and 42 participants, respectively.
There was strong evidence of an increase in score between session 1 and session 24 for both
measures (p < 0.001 for both). The mean change in score was 2.75 (95% CI 2.14 to 3.37) for carer-
rated performance and the mean change in score was 3.34 (95% CI 2.63 to 4.40) for carer-rated
satisfaction. Child-rated outcomes were available for between 10 and 12 participants. There was
evidence of an increase in score for both performance and satisfaction (p = 0.01 for both) (Table 23).
Subgroup analysis
Subgroup effects for the Aberrant Behavior Checklist – irritability

We found evidence of a differential effect of SIT on the ABC-I at 6 months by region (intervention
arm × South England region interaction = 9.77, 95% CI 4.04 to 15.49; p = 0.001), indicating higher
levels of irritability in the South England intervention arm at 6 months.
There was some evidence suggesting that there was also a differential effect of SIT on the ABC-I at
6 months by sex of child (intervention arm × female = 6.42, 95% CI 0.00 to 12.85; p = 0.050), with the
intervention being less effective in girls than in boys.
TABLE 23 Comparison of COPM scores between session 1 and session 24
Difference (session 24 – session 1)

Session 1, Session 24,
COPM n mean (SD) mean (SD) Mean (SD) 95% CI p-value
Carer rated
Performance 43 3.29 (1.46) 6.04 (1.51) 2.75 (1.99) 2.14 to 3.37 < 0.001
Satisfaction 42 3.09 (1.54) 6.43 (1.75) 3.34 (2.27) 2.63 to 4.04 < 0.001
Child rated
Performance 12 4.30 (2.00) 6.78 (1.44) 2.48 (2.75) 0.73 to 4.22 0.01
Satisfaction 10 3.89 (1.95) 6.23 (0.94) 2.34 (2.27) 0.72 to 3.96 0.01
67
There was also some evidence to suggest that the intervention was more effective in those with
ADHD (intervention arm × ADHD present = –6.77, 95% CI –13.55 to –0.01; p = 0.050). We found no
evidence of a differential effect of SIT on the ABC-I at 6 months by SPM range or general comorbidity,
or by ID and other neurodevelopmental or genetic condition specifically (Table 24).
Subgroup effects for the Autism Parenting Stress Index

Similarly, we found some evidence of a differential effect of SIT on carer stress (using the APSI) at
6 months by region (intervention arm × South England region interaction = 7.01, 95% CI 0.45 to
13.56; p = 0.04) (Table 25). There was also some evidence to suggest that there was a differential
TABLE 24 Subgroup analyses for ABC-I at 6 months
Subgroup analysis Variable Estimate 95% CI p-value
Region (reference group = South Wales) SIT main effect –2.62 –5.77 to 0.53 0.10
S-WE region main effect –8.42 –12.72 to –4.12 < 0.001
SIT × S-WE region interaction 9.77 4.04 to 15.49 0.001
Age (continuous variable) SIT main effect –5.83 –18.52 to 6.85 0.36
Age main effect –0.50 –1.66 to 0.65 0.39
SIT × age interaction 0.81 –0.80 to 2.42 0.32
Sex (reference group = male) SIT main effect –1.08 –4.16 to 2.00 0.49
Female main effect –1.96 –6.79 to 2.87 0.42
SIT × female interaction 6.42 –0.00 to 12.85 0.05
SPM range (reference group = some SIT main effect 1.82 –4.17 to 7.81 0.55
problems)
Definite dysfunction main effect 0.75 –4.63 to 6.13 0.78
SIT × definite dysfunction –1.79 –8.54 to 4.96 0.60
interaction
Comorbiditya (reference group = no SIT main effect 0.73 –3.39 to 4.84 0.73
comorbidity)
Comorbidity present main effect 3.35 –1.09 to 7.79 0.14
SIT × comorbidity present –1.08 –6.92 to 4.75 0.71
interaction
ADHDa (reference group = no ADHD) SIT main effect 1.28 –2.01 to 4.58 0.44
ADHD present main effect 7.91 2.48 to 13.34 0.01
SIT × ADHD present interaction –6.77 –13.55 to –0.01 0.05
IDa (reference group = no ID) SIT main effect –0.09 –3.26 to 3.08 0.96
ID present main effect 3.88 –3.37 to 11.13 0.29
SIT × ID present interaction –1.03 –10.10 to 8.05 0.82
Other neurodevelopmental or genetica SIT main effect –0.66 –4.06 to 2.73 0.70
(reference group = not present)
Neurodevelopmental/genetic –0.87 –5.83 to 4.09 0.73
present main effect
SIT × neurodevelopmental/ 3.29 –4.05 to 10.64 0.38
genetic present interaction
S-WE, South-west England.
a In these instances, n = 89 because of missing data for comorbidities. For all other variables n = 106.
Note
Models were fitted separately for each subgroup and adjusted for baseline ABC-I, sex of child, SPM category and
region (where not a subgroup). Main effects for SIT can be interpreted as the intervention effect on ABC-I at 6 months
in the reference group for each subgroup explored. Main effects for the subgroup can be interpreted as the association
between the subgroup category and the ABC-I score at 6 months for participants in the control arm.
68

TABLE 25 Subgroup analyses for Carer Stress at 6-months
Subgroup analysis Variable Estimate 95% CI p-value
Region (reference group = South Wales) SIT main effect –2.25 –6.05 to 1.56 0.24
S-WE region main effect –4.02 –9.30 to 1.26 0.13
SIT × S-WE region interaction 7.01 0.45 to 13.56 0.04
Age (continuous variable) SIT main effect 9.69 –4.79 to 24.18 0.19
Age main effect 0.65 –0.73 to 2.03 0.35
SIT × age interaction –1.24 –3.08 to 0.60 0.18

Sex (reference group = male) SIT main effect 0.03 –3.46 to 3.52 0.99
Female main effect 0.66 –5.34 to 6.66 0.83
SIT × female interaction 0.73 –7.24 to 8.70 0.86
SPM range (reference group = some SIT main effect 2.73 –3.58 to 9.04 0.39
problems)
Definite dysfunction main effect 1.21 –4.58 to 7.00 0.68
SIT × definite dysfunction –3.40 –10.67 to 3.87 0.36

interaction
Comorbiditya (reference group = no SIT main effect 1.31 –3.45 to 6.08 0.58
comorbidity)
Comorbidity present main effect 3.65 –1.69 to 8.99 0.18
SIT × comorbidity present –4.02 –10.78 to 2.74 0.24

interaction
ADHDa (reference group = no ADHD) SIT main effect –0.19 –4.08 to 3.69 0.92
ADHD present main effect 2.14 –4.35 to 8.62 0.51
SIT × ADHD present interaction –2.83 –10.78 to 5.13 0.48
ID (reference group = no ID)

a
SIT main effect –1.45 –4.93 to 2.03 0.41
ID present main effect 0.58 –9.43 to 10.59 0.91
SIT × ID present interaction 5.25 –6.88 to 17.39 0.39
Other neurodevelopmental or genetic a

SIT main effect 1.28 –2.44 to 4.99 0.50
(reference group = not present)
Neurodevelopmental/genetic 5.78 0.19 to 11.37 0.04
present main effect
SIT × neurodevelopmental/ –9.53 –18.08 to –0.98 0.03

genetic present interaction
S-WE, South-west England.
a In these instances, n = 70 because of missing data for comorbidities. For all other variables n = 83.
Note
Models were fitted separately for each subgroup and adjusted for baseline APSI, sex of child, SPM category and region
(where not a subgroup). Main effects for SIT can be interpreted as the intervention effect on APSI at 6 months in the
reference group for each subgroup explored. Main effects for the subgroup can be interpreted as the association
between the subgroup category and the APSI score at 6 months for participants in the control arm.
effect of SIT on APSI at 6 months by the presence of other neurodevelopmental or genetic

conditions (intervention arm × neurodevelopmental/genetic condition present = –9.53, 95% CI
–18.08 to –0.98; p = 0.030).
We found no evidence of a differential effect of SIT on the ABC-I at 6 months by sex of child, SPM
range or general comorbidity, or by ID and ADHD specifically (see Table 24).
69
Additional sensitivity analyses
Accounting for intervention receipt

Figures 10–12 highlight that scores on the ABC-I at 6 months were generally lower (i.e. better) in those
who initiated and received SIT than in those who received usual care.
Table 26 provides results from the sensitivity analyses accounting for receipt of SIT. Although the point
estimates change slightly, the conclusions drawn from the primary analysis remain unaltered.
Impact of the COVID-19 pandemic
Changes of underlying event rates and/or treatment effects may change

Primary outcome data were collected for 11 participants during the intrapandemic period.
Although exclusion of those participants with primary outcome data available during the intrapandemic
period led to an increase in our point estimate (i.e. between-arm adjusted mean difference of the
ABC-I at 6 months), the CI remained wide and the conclusions drawn on our primary analysis remain
unaltered (Table 27). Baseline to 6-month follow-up ABC-I correlation was slightly higher following
exclusion of participants who provided 6-month data during the intrapandemic period. Figure 13
illustrates differences in ABC-I scores at 6 months by arm and by time period.
0.08
0.06
ABC-I scores in those

Density
who did not initiate SIT

0.04
ABC-I scores in those
who initiated SIT
0.02
0.00
0 5 10 15 20 25 30 35 40 45
ABC-I at 6 months
FIGURE 10 Distribution of ABC-I scores at 6 months in those who did and did not initiate SIT.
0.08
0.06
ABC-I scores in those who did not
receive at least 13 SIT sessions
Density
during the intensive stage

0.04
ABC-I scores in those who received
at least 13 SIT sessions during the
intensive stage
0.02
0.00
0 5 10 15 20 25 30 35 40 45
ABC-I at 6 months
FIGURE 11 Distribution of ABC-I scores at 6 months in those who did and did not receive at least 13 SIT sessions during
the intensive phase.
70

45
40
35
30
25
20
15
10
0
0–10 11–20 > 21
Number of SIT sessions received
FIGURE 12 Box plot of ABC-I scores at 6 months for those who received differing levels of SIT.
TABLE 26 Sensitivity analysis of the primary outcome accounting for intervention receipt
Analysis n Estimate 95% CI
Primary (MITT) 106 0.40 –2.33 to 3.14
Accounting for those who had not initiated SIT by 6 months 106 0.46 –2.56 to 3.48
Accounting for the number of sessions attended by 6 months (per session) 106 0.03 –0.15 to 0.20
Accounting for the number of sessions attended by 6 months (all sessions, 106 0.69 –3.82 to 5.19
i.e. row above multiplied by 26)
Accounting for those who did not attend at least 13 sessions during the 106 0.60 –3.31 to 4.50
intensive phase
MITT, modified intention to treat.
Note
All models adjust for baseline ABC-I score, sex of child, SPM category and region.
TABLE 27 Comparison of primary analysis and primary analysis in those with primary outcome data available prior to
the COVID-19 pandemic (pre 23 March 2020)
ABC-I correlation between

Analysis n Estimate 95% CI p-value baseline and 6 months (95% CI)
Original primary analysis 106 0.40 –2.33 to 3.14 0.770 0.698 (0.585 to 0.784)
Primary analysis on participants 95 0.50 –2.40 to 3.39 0.733 0.712 (0.596 to 0.799)
followed up pre pandemic
71
45
40
35
30
ABC-I at 6 months
25
20
15
10
0
Control arm Intervention arm Control arm Intervention arm
Pre-pandemic period (n = 95) Intrapandemic period (n = 11)
FIGURE 13 Box plots of ABC-I scores at 6 months by arm and by time period.
Missing outcome data

Primary outcome data were available for 106 out of 138 participants, with 30 out of 32 missing
responses expected during the pre-pandemic period.
Intervention receipt
In total, 57 participants allocated to the intervention arm provided primary outcome data. Of these
57 participants, 38 received at least 13 out of 20 intensive intervention sessions, but 19 did not.
Pandemic-related reasons were indicated for 11 out of 19 participants who did not receive an
adequate level of SIT.
Impact of COVID-19 pandemic on trial findings

Table 28 shows that the findings in our primary analysis were insensitive to missing data and
intervention receipt that was affected by the COVID-19 pandemic.
Adverse events
There were no SAEs during the trial. One AE was reported to the trial team by a therapist as a SAE; however,
it was clear that this event did not meet the criteria of ‘serious’ as laid out in the reporting guidance.
TABLE 28 Primary outcome analysis under different scenarios
Analysis n Estimate 95% CI p-value
Original primary analysis (MITT) 106 0.40 –2.33 to 3.14 0.770
Original full ITT analysis with multiple imputation 138 0.45 –2.36 to 3.27 0.751
Primary analysis on participants followed up pre pandemic 95 0.50 –2.40 to 3.39 0.733
Pandemic-free world estimand 138 –0.20 –3.30 to 2.90 0.896
World including pandemic estimand 138 0.40 –2.30 to 3.10 0.770

ITT, intention to treat; MITT, modified intention to treat.
72

Chapter 7 Health economics
Introduction and methods
The aim of the economic evaluation was to compare the cost-effectiveness of SIT with that of usual
care. The main evaluation took an NHS/PSS perspective81 and covered use of all hospital, community
health and social services. A secondary analysis explored the sensitivity of the results using a broader
societal perspective (including NHS/PSS costs, education costs, carer expenses and lost productivity).
The primary economic analysis was an available-case analysis for cost and cost-effectiveness at 6-month
follow-up of SIT compared with usual care, with outcome expressed as irritability/agitation (i.e. ABC-I).
ABC-I data were collected at baseline and at 6 and 12 months post randomisation. All unit costs were
for the financial year 2020/21 and updated where necessary.82
Identification of resources
We collected resource use in the following cost-related profiles:
l autism-related intervention (child)

l autism-related carer programme
l education services
l use of NHS/PSS (child) –
¢ GP
¢ practice nurse
¢ speech and language therapist
¢ community paediatrician
¢ CAMHS psychiatrist
¢ clinical psychologist
¢ counsellor/psychotherapist
¢ behaviour support team
¢ social worker
¢ respite carer
¢ outreach/family support worker.
l hospital care services (child) –
¢ inpatient admission (mental health and physical health)

¢ accident and emergency attendances (requiring/not requiring hospital stay)
¢ other (e.g. occupational therapist, physiotherapist, dentist, dietitian, optician and
alternative therapies).
l police and youth justice system (child)

l use of NHS/PSS (carer) –
¢ GP
¢ practice nurse
¢ counsellor
¢ self-help/support group
¢ alternative therapist
73
HEALTH ECONOMICS
¢ telephone helpline
¢ hospital outpatient clinic
¢ inpatient admission (mental health and physical health)
¢ accident and emergency attendances (requiring/not requiring hospital stay).
l out-of-pocket expenses (carer)

l productivity costs (carer)
¢ half-days off work (main carer) owing to participant’s condition.
Measure of resources
Intervention delivery
The intervention arm received 24 face-to-face and two telephone sessions, which were used as the
basis for calculation of intervention costs.
Usual care
Data on usual-care services and support were recorded using the CSRI,75 and were adapted to reflect
the type of data collected and to record service use that would facilitate cost estimation. Usual care
involved contact with OT, autism-specific services and any other NHS services.
NHS/Personal Social Services

Information about the use of services by participants and carers was collected from carers at baseline
and at 6- and 12-month follow-up, covering a retrospective 6-month period. Carers were asked to record
contact with various services and professionals (for themselves and their child). At each time point,
service use since the previous assessment was recorded.
Productivity losses
Data regarding the number of half-days taken off work by the main carer to provide support were
collected (last 6 months).
Valuation of resources
All resources were costed by applying a unit cost (GBP) for the financial year 2020–21. Total resource
use was calculated for each participant.
Sensory integration therapy sessions

The unit cost of an occupational therapist was derived using established unit costing principles.83
Therapists were NHS band 7 and national insurance, superannuation contributions and overheads
were added to the average salary. We used protocol-driven information on intervention sessions.
A total of 24 sessions were delivered face to face and two were conducted over the telephone.
All sessions lasted approximately 1 hour. To derive the cost of the intervention, we multiplied
occupational therapist time spent delivering the intervention by the unit cost of an occupational
therapist. The total cost of intervention delivery over 6 months was £1538.16 (Table 29), which is
equivalent to a monthly cost of £256.36 per person.
NHS/Personal Social Services

For all health-care and social care service use data, including voluntary sector, nationally applicable unit
costs were attached at 2020–21 prices, or at the most recent price level on which costs were available,
to reflect long-run marginal opportunity costs from available public sources. Costs older than the
chosen financial year were inflated using the NHS Cost Inflation Index.82
74

TABLE 29 Unit cost (2020/21) of SIT sessions
Unit Unit cost
Cost per working hour £59.16a
Number of face-to-face sessionsb 24
Session duration 1 hour
Total cost £1538.16

a Curtis and Burns,82 inflated to 2020/21 using NHS Cost
Inflation Index.
b Two additional sessions delivered by telephone.
Costs per unit of measurement for each NHS/PSS service type were taken from the Personal Social
Services Research Unit Costs of Health and Social Care compendium.82 NHS reference costs84 were
used for inpatient and outpatient attendances and community-based services. Unit costs not obtained
from these sources were estimated directly based on salary of the professional delivering a service,
plus employer on-costs, overheads, costs of supervision and equipment/consumables.
Productivity costs
Productivity losses were calculated by multiplying time taken off work by carer’s wage rate. We calculated
the hourly rate for each carer by dividing their gross annual income by the number of weeks per year and
weekly working hours reported. We then multiplied rate per hour by number of hours in the half-days off
work reported at follow-up assessments (Table 30).
TABLE 30 Unit costs
Service (unit) Cost (£) Source
Autism-related therapies
Early intensive applied behaviour analysis (minute) 0.37 Rodgers et al.85
Social skills programme (hour) 25.00 Blooming Tree86
Parent-mediated communication programme 1.90 Byford et al.,87 inflated to 2020/21 prices82

(minute)
Behaviour management training (day) 75.00 Child Autism UK88
Alternative and augmentative systems (day) 200.00 Ace Centre89
Parent nurture programme (hour) 95.00 Connect to Autism90
ASD awareness (hour) 23.00 Dulwich Prep London91

Cygnet/one-to-one classes with Bernardo’s 185.00 Stuttard et al.,92 inflated to 2020/21 prices82
(session)
Education-based services
Individual tuition at home (hour) 60.00 Tutorful93

One-to-one support in school (hour) 8.89 Payscale94
Group support in school (hour) 11.64 Education Endowment Foundation95
School nurse (hour) 49.20 Prospects,96 Curtis and Burns,82 inflated to

2020/21 prices
Educational psychologist (minute) 0.99 Prospects,96 Curtis and Burns,82 inflated to

2020/21 prices
continued
75
HEALTH ECONOMICS
TABLE 30 Unit costs (continued )
School counsellor (minute) 0.82 Prospects,96 PSSRU 2020, inflated to 2020/21 prices
SEN co-ordinator (minute) 0.61 Prospects,96 Curtis and Burns,82 inflated to

2020/21 prices
Autism specialist teacher (minute) 0.61 Prospects,96 Curtis and Burns,82 inflated to
2020/21 prices
Autism champion (minute) 0.53 Curtis and Burns,82 inflated to 2020/21 prices
Community-based services
GP visit (minute) 4.35 Curtis and Burns,82 inflated to 2020/21 prices
Practice nurse (minute) 0.71 Curtis and Burns,82 inflated to 2020/21 prices
CAMHS (minute) 0.82 Curtis and Burns,82 inflated to 2020/21 prices
Occupational therapist (minute) 0.83 Curtis and Burns,82 inflated to 2020/21 prices
Speech and language therapist (minute) 0.69 Curtis and Burns,82 inflated to 2020/21 prices
CAMHS psychiatrist (minute) 2.67 Curtis,97 inflated to 2020/21 prices

Clinical psychologist (minute) 2.59 Curtis,97 inflated to 2020/21 prices
Counsellor/psychotherapist (minute) 1.65 Curtis and Burns,82 inflated to 2020/21 prices
Behaviour support team (minute) 1.01 Netten and Curtis,98 inflated to 2020/21 prices
Social worker (minute) 1.30 Curtis and Burns,82 inflated to 2020/21 prices
Outreach worker (minute) 0.43 Curtis and Burns,82 inflated to 2020/21 prices
Dietitian (minute) 1.60 Curtis and Burns,99 inflated to 2020/21 prices
Radiographer (minute) 0.88 Curtis and Burns,82 inflated to 2020/21 prices

Physiotherapist (minute) 0.84 Curtis and Burns,82 inflated to 2020/21 prices
Endocrine consultant (minute) 2.00 Curtis and Burns,82 inflated to 2020/21 prices
Helpline (minute) 0.82 The National Archives,100 inflated to 2020/21 prices
Integrated Community Mental Health Teams 0.78 Curtis and Burns,101 inflated to 2020/21 prices
(minute)
Primary mental health worker (minute) 0.77 Curtis and Burns,99 inflated to 2020/21 prices
Continence nurse (minute) 1.38 Curtis and Burns,99 inflated to 2020/21 prices
Counsellor (hour) 55.54 Slade et al.,102 inflated to 2020/21 prices
Community paediatrician (contact) 157.00 Curtis and Burns,82 inflated to 2020/21 prices
Respite care (session) 100.00 NHS103
Paediatric consultant (contact) 241.70 Curtis and Burns,82 inflated to 2020/21 prices
Optician (contact) 33.30 Curtis and Burns,104 inflated to 2020/21 prices
Dentist (contact) 135.90 Curtis and Burns,82 inflated to 2020/21 prices
Audiologist (contact) 107.80 Curtis and Burns,82 inflated to 2020/21 prices
CBT therapist (session) 106.00 Curtis and Burns,82 inflated to 2020/21 prices
Hydrotherapy (session) 80.00 The Canine Fitness Centre105
Chiropractor (session) 55.00 NHS106
Art therapy (session) 18.50 Uttley et al.107
76

TABLE 30 Unit costs (continued )
Hospital-based care
Inpatient admission: physical health 3440.16 Department of Health and Social Care,84 inflated to
(bed-days) 2020/21 prices
Accident and emergency: not admitted 145.21 Department of Health and Social Care,84 inflated to
(attendance) 2020/21 prices
Accident and emergency: admitted 174.46 Department of Health and Social Care,84 inflated to
(attendance) 2020/21 prices
Hospital outpatient clinic (appointments) 206.85 Department of Health and Social Care,84 inflated to
2020/21 prices
Day hospital (attendance) 785.61 Department of Health and Social Care,84 inflated to
2020/21 prices
CBT, cognitive–behavioural therapy; PSSRU, Personal Social Services Research Unit; SEN, special educational needs.
Data analysis
Resource use was reported as means by arm and as a percentage of the arm having at least one
contact. Differences in service use between arms (i.e. baseline, 6-month follow-up and 12-month
follow-up) were reported descriptively. All relevant data on service use and support were checked
for missing values and values outside an acceptable range. Missing data were imputed using
multiple imputation.
Service and support use

Differences in the number of participants using each type of service and the mean number of contacts
were compared between arms at baseline, 6 months and 12 months. Resource use patterns are
presented descriptively, given that the economic evaluation was focused on NHS/PSS and societal
costs and cost-effectiveness and to avoid multiple testing.
Analysis of costs
The health economic analysis was an available-case analysis. Costs were calculated using data on
the type, number and length of contacts. Mean costs were analysed using regression analysis and
bootstrapping. We analysed differences between arms in health-care (i.e. NHS/PSS) or societal costs
in secondary analyses at 6 months by regressing the total cost on treatment allocation, baseline ABC-I,
recruitment region, severity of SPDs, sex of child and baseline costs. To mitigate effects of data
skewness, non-parametric bootstrapping methods were used to estimate 95% CIs for mean costs with
10,000 resamples. No discounting was needed, as we assessed cost over periods of < 1 year.
Cost-effectiveness analysis
Cost-effectiveness analyses were conducted from an NHS/PSS perspective and a wider societal
perspective. The primary economic analysis focused on cost-effectiveness of SIT compared with
usual care, assessed in terms of cost per point improvement in carer-reported ABC-I. The incremental
cost-effectiveness ratio (ICER) was calculated as the difference in mean costs divided by difference in
mean ABC-I.108
77
HEALTH ECONOMICS
Cost-effectiveness acceptability curves (CEACs) were plotted to locate findings in their wider decision-
making context. Non-parametric bootstrapping from cost and effectiveness data generated a joint
distribution of incremental mean costs and effects for comparators to explore the probability that each
is the optimal choice, subject to a range of maximum values (i.e. a ceiling ratio) that a decision-maker
might be willing to pay for an additional point improvement in ABC-I. Each CEAC was derived using a
net benefit approach. Monetary values of incremental effects and incremental costs for each case were
combined, and net monetary benefit was derived as:
net monetary benefit = λ × (effect b − effect a) − (cost b − cost a), (1)
where λ is willingness to pay for a 1-point difference in ABC-I, and a and b denote SIT and usual care,
respectively. We explored a range of willingness-to-pay values for each outcome.
Sensitivity analyses
An intention-to-treat analysis was carried out (with missing data imputed using multiple imputation)
to explore the sensitivity of results using a broader societal perspective, including NHS/PSS costs,
education service costs, carer expenses and lost productivity.
Results
Data completeness
At baseline, service use data were available for 138 participants (intervention, n = 69; usual care,
n = 69). At 6-month follow-up, data were available for 60% of participants (intervention, n = 48;
usual care, n = 35). At 12-month follow-up, 23 and 36 participants provided data in the control arm
and intervention arm, respectively.
Resource use
The difference in service use between arms at baseline was broadly similar (Table 31). As shown in Table 32,
at 6-month-follow-up, usual-care participants reported considerably higher contact with education
services [mean 425.97 (SD 388.37) vs. mean 333.46 (SD 354.10)], slightly greater use of community-
based health and social care services and more accident and emergency unit attendances (14.29% vs.
6.25%) than participants in the intervention arm. However, carers in the intervention arm spent,
on average, more half-days off work [mean 18.19 (SD 37.22) days vs. mean 4.14 (SD 9.02) days].
At 12-month follow-up, modest but higher utilisation of health-care and social care resources was
reported by families in the intervention arm across all categories (Table 33).
Caregiver-reported gross income and the mean annual income was £17,537.31 (SD $15,909.86)
for SIT and £18,405.8 (SD £14,956.87) for usual care.
Total costs
The total costs for the child, sibling and carers by sector and perspective were reported as adjusted
mean differences with bias-corrected 95% CIs.
NHS/Personal Social Services perspective

At baseline, the main contributor to the total NHS/PSS cost was community-based care. Education-based
services constituted the major proportion of societal cost (Table 34). From an NHS/PSS perspective,
the mean total health-care and social care cost at 6 months (Table 35) was £1915.2 in the intervention
arm and £554.42 in the control arm. The adjusted mean difference was statistically significant (£1325.1,
95% CI £1057.6 to £1592.6). When SIT costs were not included in the total NHS/PSS costs, NHS/PSS
costs were significantly higher for usual care than for SIT at 6 months (mean –£177.38, 95% CI
–£431.36 to £76.59).
78

TABLE 31 Service use (unit) at baseline (for previous 6 months)
Study arm
SIT (N = 69) Usual care (N = 69)
Service use (unit) n (%) using Mean (SD) n (%) using Mean (SD)
Child
Autism intervention package (contact) 3 (4.35) 0.09 (0.54) 6 (8.70) 0.87 (5.01)
Service use by the child: education 61 (88.41) 332.59 (448.07) 64 (92.75) 302.51 (350.94)
(contact)
Community-based health and social care
GP (contact) 29 (42.03) 0.88 (1.81) 26 (37.68) 0.88 (1.57)
Paediatrician (contact) 21 (30.43) 0.33 (0.56) 22 (31.88) 0.44 (0.74)
SLT (contact) 13 (18.84) 0.61 (2.55) 15 (21.74) 0.44 (1.01)
Other community health-care 43 (62.31) 4.00 (5.86) 49 (71.01) 4.32 (7.14)

services (contact)
Hospital-based health and social care
Inpatient stay: physical health 2 (2.90) 0.04 (0.27) 1 (1.45) 0.02 (0.12)
(bed-days)
Accident and emergency: 6 (8.70) 0.22 (1.22) 8 (11.59) 0.22 (0.84)

not admitted (attendance)
Sibling
Counsellor (contact) 9 (13.04) 1.29 (4.52) 6 (8.70) 0.36 (1.40)

services (contact)
Carer
Autism-related training (minute) 19 (27.54) 2.09 (5.04) 19 (27.54) 1.25 (2.92)
GP (contact) 29 (42.03) 1.93 (5.23) 22 (31.88) 1.22 (2.34)

services (contact)
Inpatient stay: physical health 0 (0.00) 2 (2.90) 0.04 (0.27)

(bed-days)
Accident and emergency: not 2 (2.90) 0.03 (0.17) 3 (4.35) 0.04 (0.21)
admitted (attendance)
Accident and emergency: admitted 0 (0.00) 2 (2.90) 0.06 (0.38)

(attendance)
Hospital outpatient clinic 7 (10.14) 0.19 (0.67) 7 (10.14) 0.46 (1.88)
(appointments)
Out-of-pocket expensesa 50 (72.46) 38 (55.07)
Half-days off work 29 (42.03) 10.07 (23.27) 26 (37.68) 5.49 (24.27)

a Covers adaptation, special equipment, damage cost, medication, extra help, special education, therapy, special
activities and travel expenses.
79
HEALTH ECONOMICS
TABLE 32 Service use (unit) at 6-month follow-up (for previous 6 months)
Study arm
Child
(contact)
GP (contact) 15 (31.25) 0.92 (1.97) 9 (25.71) 0.66 (1.64)
SLT (contact) 7 (14.58) 0.54 (1.97) 9 (25.71) 0.69 (1.35)

services (contact)

Sibling

services (contact)
Carer
Autism-related training (minute) 9 (18.75) 1.02 (2.48) 9 (25.71) 2.17 (6.98)

GP (contact) 19 (39.58) 1.38 (2.38) 14 (40.00) 1.03 (1.47)

services (contact)

Inpatient stay: physical health 1 (2.08) 0.08 (0.58) 0 (0.00)
(bed-days)
Accident and emergency: admitted 1 (2.08) 0.02 (0.14) 0 (0.00)

(attendance)

(appointments)

a This includes adaptation, special equipment, damage cost, medication, extra help, special education, therapy, special
80

TABLE 33 Service use (unit) at 12-month follow-up (for previous 6 months)
Study arm
Child
(contact)
GP (contact) 10 (27.78) 0.44 (0.88) 4 (17.39) 0.22 (0.52)
SLT (contact) 6 (16.67) 0.64 (2.17) 3 (13.04) 0.39 (1.08)

services (contact)

Sibling

services (contact)
Carer
Autism-related training (minute) 5 (13.89) 0.42 (1.54) 0 (0.00)

GP (contact) 14 (38.89) 1.25 (2.31) 6 (26.09) 0.57 (1.04)

services (contact)

Inpatient stay: physical health 2 (5.56) 0.06 (0.23) 0 (0.00)
(bed-days)
Accident and emergency: not 2 (5.56) 0.06 (0.23) 0 (0.00)

admitted (attendance)
Accident and emergency: admitted 2 (5.56) 0.06 (0.23) 0 (0.00)

(attendance)

(appointments)

a Covers adaptation, special equipment, damage cost, medication, extra help, special education, therapy, special
81
HEALTH ECONOMICS
TABLE 34 Total costs (£) at baseline by arm (for previous 6 months)
Study arm (£)
Usual care
SIT (n = 69), (n = 69), Unadjusted mean difference Adjusted mean difference
Cost mean (SD) mean (SD) (95% CI) (£) (95% CI) (£)a,b
a. Child
Autism 1.46 (12.13) 45.6 (321.11) –44.14 (–120.64 to 32.36) –42.64 (–114.22 to 28.93)
intervention
package
Community- 426.99 (542.62) 409.24 (622.14) 17.76 (–178.77 to 214.29) 23.37 (–168.60 to 215.35)
based care
Hospital-based 181.14 (932.45) 81.42 (427.93) 99.71 (–144.54 to 343.97) 95.59 (–149.59 to 340.78)
care
Total health and 609.59 (1112.9) 536.26 (833.52) 73.34 (–257.69 to 404.36) 76.32 (–266.29 to 418.93)
social care (child)
b. Sibling
NHS/PSS 142.69 (452.48) 52.17 (161.33) 90.53 (–23.83 to 204.89) 89.96 (–19.98 to 199.92)
c. Carer
Autism-related 264.04 (806.26) 199.11 (543.17) 64.92 (–166.52 to 296.37) 47.86 (–165.08 to 260.79)
training
Community- 270.84 (784.84) 214.85 (548.35) 55.98 (–171.95 to 283.92) 59.99 (–162.39 to 282.37)
based care
Hospital-based 43.18 (142.74) 207.02 (834.00) –163.83 (–365.27 to 37.60) –167.58 (–361.59 to 26.42)
care
d. Out-of-pocket 1016.1 (3632.2) 234.43 (513.37) 781.64 (–91.67 to 1654.9) 804.14 (–132.81 to 1741.1)
expenses
(caregiver)
e. Unpaid care 478.33 (1354.2) 436.39 (2859.9) 41.94 (–711.40 to 795.29) 25.38 (–761.14 to 811.89)
f. Education 3465.6 (4573.5) 2982.7 (3336.8) 482.81 (–864.98 to 1830.6) 527.64 (–827.22 to 1882.5)
(child)
Total societal 6290.3 (6378.2) 4862.9 (5019.7) 1427.33 (–504.98 to 3359.6) 1463.7 (–488.33 to 3415.7)
(a–f)
a Bias-corrected 95% CIs.
b Adjusted for baseline ABC-I, recruitment region, severity of SPDs and sex of child.
Societal perspective
From a societal perspective, the mean total costs at baseline were £6290.30 and £4862.90 for SIT
and usual care, respectively. The adjusted mean difference in costs of £1463.70 was not statistically
significant (95% CI –£488.33 to £3415.70) (see Table 34). The mean total societal costs, including
intervention at 6 months, were £6784.2 and £6418.9 for the intervention arm and control arm,
respectively. The adjusted mean difference was not statistically significant (mean –£353.57, 95% CI
–£3518.9 to £2811.7). When intervention costs were excluded, the mean total societal cost at 6 months
was statistically higher for usual care than for SIT (mean –£1891.70, 95% CI –£5022.10 to £1238.70).
Costs measured at 12 months were higher overall in the intervention arm, with an adjusted difference
in total societal care cost of £1141.50 (95% CI £1333.4 to £3616.4); however, the adjusted mean difference
was not statistically significant (Table 36).
82

TABLE 35 Total costs (£) at 6-month follow-up by arm (for previous 6 months)
Study arm (£)
Usual care
a. Intervention 1538.16 (–)

cost
b. Child
Autism 3.28 (17.43) 46.56 (188.79) –43.28 (–97.69 to 11.13) –46.40 (–110.83 to 18.02)
intervention
package
Community- 361.65 (449.41) 487.11 (675.27) –125.46 (–371.14 to 120.21) –218.26 (–432.68 to –3.85)
based care
Hospital- 12.10 (50.42) 20.74 (51.55) –8.64 (–31.15 to 13.87) –8.57 (–31.42 to 14.27)
based care
Total health and 377.04 (455.67) 554.42 (706.16) –177.38 (–431.36 to 76.59) –213.07 (–484.49 to 58.37)
social care
Total health and 1915.2 (455.67) 554.42 (706.16) 1360.8 (1106.8 to 1614.8) 1325.1 (1057.6 to 1592.6)
social care
(a + b)
c. Sibling
NHS/PSS 49.47 (144.32) 15.88 (49.56) 33.59 (–17.06 to 84.24) 19.91 (–18.27 to 58.09)
d. Carer
Autism- 180.79 (548.03) 145.67 (428.49) 35.12 (–186.59 to 256.84) 31.35 (–186.16 to 248.86)
related
training
Community- 179.99 (300.10) 118.26 (238.89) 61.73 (–60.36 to 183.82) 52.01 (–59.84 to 163.86)
based care
Hospital- 139.94 (570.36) 53.19 (220.64) 86.76 (–115.52 to 289.03) 96.86 (–71.63 to 265.35)
based care
e. Out-of-pocket 253.42 (782.64) 137.66 (359.87) 115.76 (–167.34 to 398.86) 154.68 (–133.29 to 442.66)
expenses
(caregiver)
f. Unpaid care 749.49 (2176.88) 72.66 (148.22) 676.83 (–57.74 to 1411.4) 77.34 (–233.47 to 388.16)
g. Education 3315.9 (3309.9) 5321.2 (8518.5) –2005.2 (–4688.7 to 678.17) –2150.3 (–5373.2 to 1072.5)
(child)
Total societal 5246.1 (3727.1) 6418.9 (8866.3) –1172.8 (–4006.6 to 1660.9) –1891.7 (–5022.1 to 1238.7)
without
intervention
(b–g)
Total societal 6784.2 (3727.1) 6418.9 (8866.3) 365.32 (–930.3 to 4737.3) –353.57 (–3518.9 to 2811.7)
with
intervention
(a–g)
83
HEALTH ECONOMICS
TABLE 36 Total costs (£) at 12-month follow-up by arm (for previous 6 months)
Study arm (£)
Usual care
a. Intervention 1538.16 (–)

cost
b. Child
Autism 26.24 (120.47) 0.73 (3.50) 25.51 (–24.97 to 75.98) 26.68 (–19.67 to 73.02)
intervention
package
Community- 615.73 (1299) 229.79 (443.26) 385.93 (–177.73 to 949.60) 288.38 (–94.13 to 670.89)
based care
care
Total health and 658.11 (1324.29) 236.84 (454.70) 421.27 (–153.62 to 996.15) 403.02 (–93.74 to 899.78)
social care
Total health and 2196.3 (1324.3) 236.84 (454.70) 1959.4 (1384.5 to 2534.3) 1941.1 (1476.3 to 2406)
social care (a + b)
c. Sibling
NHS/PSS 273.08 (922.12) 91.13 (273.20) 181.94 (–214.81 to 578.69) 103.03 (–247.77 to 453.82)
d. Carer
Autism-related 5.89 (25.96) 0.00 (–) 5.89 (–4.97 to 16.77) 6.75 (–3.71 to 17.22)
training
Community- 208.43 (476.77) 259.77 (754.44) –51.34 (–371.73 to 269.05) –75.43 (–424.1 to 273.25)
based care
care
e. Out-of-pocket 92.92 (267.23) 51.35 (87.11) 41.56 (–74.04 to 157.18) 18.92 (–53.1 to 90.94)
expenses
(caregiver)
f. Unpaid care 369.26 (859.86) 159.91 (440.33) 209.35 (–179.37 to 598.06) 165.17 (–177.92 to 508.28)
g. Education (child) 3587.6 (3596.5) 3665.4 (4625.6) –77.89 (–2229.39 to 2073.6) –335.71 (–2241.6 to 1570.2)
Total societal 5421.4 (5153.2) 4563.4 (5190.5) 857.98 (–1904.3 to 3620.3) –396.65 (–2870.8 to 2077.5)
without
intervention (b–g)
Total societal with 6959.5 (5153.2) 4563.4 (5190.5) 2396.1 (–366.1 to 5158.4) 1141.5 (–1333.4 to 3616.4)
intervention (a–g)
a Bias-corrected 95% CIs,
Outcomes
Cost-effectiveness: 6-month follow-up

In terms of challenging behaviour, NHS/PSS costs were higher in the intervention arm than in the control
arm and outcome showed no statistically significant difference, generating an ICER (i.e. the additional
cost divided by the additional effects) of £3312.75 per 1-point improvement in the ABC-I score from
the NHS/PSS perspective (Table 37). For the secondary analysis, we explored cost-effectiveness from a
societal perspective and evaluated incremental cost per point improvement in ABC-I over the same period.
84

TABLE 37 Differences in incremental costs, effect and cost-effectiveness at 6 and 12 months
Health and social care perspective, mean

(95% CI) Societal perspective, mean (95% CI)
Item 6 months 12 months 6 months 12 months
Incremental cost £1325.1 £1941.1 £1184.5 £1141.5

(£1057.6 to £1592.6) (£1476.3 to £2406) (–£1906.2 to £4275.4) (–£1333.4 to £3616.4)
Points improvement 0.40 2.01 0.40 2.01
in ABC-I (–2.37 to 3.17) (–5.37 to 1.35) (–2.37 to 3.17) (–5.37 to 1.35)
ICER: additional £3312.75 £965.72 Mean differences in Mean differences in

cost per additional costs and outcome did costs and outcome did
point improvement not reach statistical not reach statistical
in ABC-I significance (5% level) significance (5% level)
It was not necessary to calculate ICERs, as there were no significant differences in costs and effects in
the primary outcome. However, there is uncertainty around these results. A Bayesian decision-making
approach was adopted, and available data on costs and effects were used to plot a CEAC. Non-parametric
bootstrapping generated a joint distribution of incremental mean costs and effects for SIT compared
with usual care to explore the probability of SIT being cost-effective subject to a range of values (λ) that
a decision-maker might be willing to pay for an improvement in outcomes.
Figures 14 and 15 present scatterplots of the bootstrapped cost and effectiveness of SIT compared
with usual care, from NHS/PSS and societal perspectives. Points in the scatterplot for the NHS/PSS
perspective fall in the north-east and north-west quadrants of the cost-effectiveness plane, suggesting
that SIT is more costly than usual care, with unclear conclusions regarding effectiveness. Points in the
scatterplot for the societal perspective fall in all four quadrants of the cost-effectiveness plane.
1800
1400
Incremental cost (£)
1000
600
200
–200
–4 –2 0 2 4 6
Incremental ABC-I score
FIGURE 14 Bootstrapped mean differences in health and social care costs and effects (6-month ABC-I total score):
cost-effectiveness plane – SIT vs. usual care (NHS/PSS perspective).
85
HEALTH ECONOMICS
6000
4000
2000
–2000
–4000
–6000
–8000
–10,000
–4 –2 0 2 4 6
FIGURE 15 Bootstrapped mean differences in societal costs and effects (6-month ABC-I total score): cost-effectiveness
plane – SIT vs. usual care (societal perspective).
Statistical uncertainty around the ICER was explored using CEACs (Figures 16 and 17). Given the
lack of suggested monetary thresholds for assessing cost-effectiveness using ABC-I, we assumed a
willingness-to-pay threshold of £500. The probability that SIT is cost-effective from the NHS/PSS
perspective was < 10% (see Figure 16). From the wider societal perspective (including education services,
carers’ health-care use, out-of-pocket expenses and lost productivity, in addition to health and social
care costs), the probability that SIT is cost-effective increased to just under 60% for a willingness-to-pay
threshold of £500 (see Figure 17). At 6 months, the probability that SIT is cost-effectiveness rose from
10% under an NHS/PSS perspective to 60% under a societal perspective because of the higher cost
of education in the control arm. Higher education costs offset costs in NHS/PSS and in other sectors,
closing the gap in societal care costs at 6 months between arms (from £1360.80 under an NHS/PSS
perspective to £356.32 under a societal perspective; see Table 35).
1.0
0.9
Probability that SIT is cost-effective
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.0
0 100 200 300 400 500 600 700 800 900 1000
Willingness-to-pay threshold (£)
FIGURE 16 Health-care and social care costs and effects (6-month ABC-I scores): CEAC.
86

1.0
0.9

0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.0
0 100 200 300 400 500 600 700 800 900 1000
FIGURE 17 Societal costs and effects (6-month ABC-I scores): CEAC.
Cost-effectiveness: 12-month follow-up

At 12 months, it was not necessary to calculate the ICER, as there were no significant differences in
costs and ABC-I scores under both the NHS/PSS and the societal perspectives (see Table 37). Figures 18
and 19 present scatterplots of the bootstrapped cost and effectiveness for SIT compared with usual
care, from the NHS/PSS and societal perspectives at 12 months. Points in the scatterplot for the
NHS/PSS perspective fall in the north-east and north-west quadrants of the cost-effectiveness plane,
suggesting that SIT is more costly than usual care, with unclear conclusions regarding effectiveness.
Points in the scatterplot for the societal perspective fall in all four quadrants of the cost-effectiveness
plane, but are more concentrated in the north-east and north-west quadrants, suggesting that SIT is
more costly than usual care, with unclear effectiveness.
5000
4000
3000
2000
1000
–1000
–10 –5 0 5 10
FIGURE 18 Bootstrapped mean differences in health-care and social care costs and effects (12-month ABC-I total score):
cost-effectiveness plane – SIT vs. usual care (NHS/PSS perspective).
87
HEALTH ECONOMICS
9000
7000
5000
3000
1000
–1000
–3000
–5000
–10 –5 0 5 10
FIGURE 19 Bootstrapped mean differences in societal costs and effects (ABC-I total score: 12-month complete-case
analysis): cost-effectiveness plane – SIT vs. usual care (NHS/PSS perspective).
Cost-effectiveness acceptability curves for the 12-month follow-up showed similar results to the
6-month follow-up (Figures 20 and 21). The probability that SIT is cost-effective from the NHS/PSS
perspective was < 10% (see Figure 20). From the wider societal perspective, the probability that SIT is
cost-effective was just over 30% for a willingness-to-pay threshold of £500 (see Figure 21).
Impact of COVID-19
Follow-up resource use measures were collected via telephone, post and online. We expected minimal
impact of COVID-19 on the proportion of participants providing information on resource use data and
no meaningful difference between arms. However, we saw a reduction in overall service use owing to
limited access. To explore potential impact on results, an intention-to-treat analysis was conducted
1.0
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.0
0 100 200 300 400 500 600 700 800 900 1000
FIGURE 20 NHS/PSS perspective (12-month ABC-I scores): CEAC.
88

1.0
0.9

0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.0
0 100 200 300 400 500 600 700 800 900 1000
FIGURE 21 Societal perspective (12-month ABC-I scores): CEAC.
(with missing data imputed assumed missing at random). We used multiple imputation using chained
equations, fitting five imputations,109 assuming a predictive mean matching model with baseline ABC-I
scores, baseline total cost, severity of SPDs, region and sex of child. We then performed a parametric
bootstrap with the multiple imputed data set to obtain bias-corrected estimates of incremental cost
and effect. The results did not alter conclusions drawn from the main analysis (Table 38). Total health
and social care costs from an NHS/PSS perspective for 6 and 12 months were higher for SIT than for
usual care. The adjusted mean differences between SIT and usual care for 6- and 12-month follow-up
were statistically significant at 1317.2 (95% CI 1116.5 to 1517.9) and 2149.5 (95% CI 1807.8 to 2491.3),
TABLE 38 Total costs (£) at 6- and 12-month follow-up by arm
Study arm
SIT (n = 69), Usual care (n = 69), Unadjusted mean difference Adjusted mean difference
Variable mean (SD) mean (SD) (95% CI) (95% CI)a,b
6 months
Total health- 1919.18 (66.03) 563.03 (112.78) 1356.15 (1087.58 to 1624.72) 1317.2 (1116.5 to 1517.9)
care and social
care cost (£)
cost (£)
Outcome: 18.29 (1.12) 18.47 (1.47) –0.18 (–3.94 to 3.59) –0.38 (–3.59 to 3.52)
ABC-I
12 months
Total health- 2111.3 (146.63) 245.49 (80.90) 1865.8 (1519.5 to 2212.1) 2149.5 (1807.8 to 2491.3)
care and social
care cost (£)
cost (£)
Outcome: 17.73 (1.36) 19.44 (1.51) –1.70 (–6.08 to 2.68) –1.64 (–4.14 to 0.85)
ABC-I
89
HEALTH ECONOMICS
respectively. From a societal perspective, the adjusted mean difference between arms at 6 and 12 months
suggests that SIT was more costly than usual care; however, the mean difference was not statistically
significant (see Table 38). ICERs generated from an NHS/PSS perspective are shown in Table 39.
Statistical uncertainty around the ICER was explored for imputed data using CEACs (Figures 22–25).
Using a monetary threshold of £500, the probability that SIT is cost-effective, from the NHS/PSS
perspective at 6-month follow-up, was just over 0.2% and increased to just over 30% for a willingness-
to-pay threshold of £1000 (see Figure 22). From a wider societal perspective, the probability that the
intervention is cost-effective was just over 20% (see Figure 23). CEACs for the 12-month follow-up
concur with the conclusion that SIT has a low probability of cost-effectiveness from both the NHS/PSS
and the societal perspectives (see Figures 24 and 25).
Summary
Delivery of SIT incurred significant additional costs. When intervention costs were not included in total
NHS/PSS costs, NHS/PSS costs of care for usual care-only participants were significantly higher than
for SIT participants. The mean difference in ABC-I scores between arms did not achieve statistical
significance at 6 or 12 months, suggesting no additional clinical benefit of SIT. Economic evidence
suggests that SIT has a low probability of being a cost-effective option compared with usual care.
TABLE 39 Differences in incremental costs, effect and cost-effectiveness at 6 and 12 months
Health and social care perspective, mean

(95% CI) Societal perspective, mean (95% CI)
Item 6 months 12 months 6 months 12 months
Incremental costs £1317.2 £2149.5 £1016.2 £1844.7

(£1116.5 to £1517.9) (£1807.8 to £2491.3) (–£776.33 to £2808.8) (–£73.63 to £3763.0)
Points improvement 0.38 1.64 0.38 (–3.59 to 3.52) 1.64

in ABC-I score (–3.59 to 3.52) (–4.14 to 0.85) (–4.14 to 0.85)
ICER: additional £3466.3 £1310.7 Mean differences in Mean differences in

cost per additional costs and outcome did costs and outcome did
point improvement not reach statistical not reach statistical
in the ABC-I scale significance (5% level) significance (5% level)
1.0
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.0
0 100 200 300 400 500 600 700 800 900 1000
FIGURE 22 Imputed data set: NHS/PSS perspective (6-month ABC-I scores) – CEAC.
90

1.0
0.9

0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.0
0 100 200 300 400 500 600 700 800 900 1000
FIGURE 23 Imputed data set: societal perspective (6-month ABC-I scores) – CEAC.
1.0
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.0
0 100 200 300 400 500 600 700 800 900 1000
FIGURE 24 Imputed data set: NHS/PSS perspective (12-month ABC-I scores) – CEAC.
1.0
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.0
0 100 200 300 400 500 600 700 800 900 1000
FIGURE 25 Imputed data set: societal perspective (12-month ABC-I scores) – CEAC.
91
Chapter 8 Process evaluation: recruitment,

retention, fidelity and safety
T he SenITA trial included a process evaluation that was conducted alongside the main trial.
In accordance with Medical Research Council guidance, the process evaluation aimed to examine:110
l recruitment of participants and therapists

l retention
l fidelity
l acceptability
l adherence
l adverse effects
l contamination.
These process evaluation components also formed part of the internal pilot (see Chapter 4). In addition,
the process evaluation sought to explore contextual factors that might have an effect on the outcome
of the intervention.
Methods and materials
Research design
The process evaluation employed a mixed-methods approach. Quantitative methods were used to assess
recruitment rates/patterns, attendance and intervention fidelity. Qualitative interviews with therapists
involved in intervention delivery and carers of children enrolled in the trial examined experiences of the
trial recruitment process, the acceptability of trial processes and measures, intervention implementation
and acceptability, and the role of contextual factors. Methods for collecting data as part of the process
evaluation are described in the following sections. Table 40 summarises each set of data collected, the
method of data collection and the objectives addressed.
Quantitative data collection
Recruitment of participants and therapists

Baseline data were used to describe the characteristics of the recruited sample (e.g. age, degree of
SPD and autism symptoms). The baseline data provide an indication of the trial ‘reach’, that is whether
or not the intervention reaches the intended population. This is described here as the proportion of
those eligible who were then recruited (see Chapter 10 for a discussion of sample representativeness).
The number of people eligible (expressed as the proportion of those approached) and randomised
(expressed as the proportion of those eligible) were utilised within the process evaluation.
Sixteen therapists were recruited to deliver the intervention across eight sites/clinics.
Retention
The clinical database was used to capture retention data, that is the number of people with missing
outcome data at 6 and 12 months post randomisation (as a proportion of those who had been
randomised and reached the time point).
93
94
PROCESS EVALUATION: RECRUITMENT, RETENTION, FIDELITY AND SAFETY

TABLE 40 Summary of process evaluation data sources and objectives
Process evaluation component
Participant Intervention Contamination in

Data source Recruitment retention fidelity Acceptability Adherence Adverse effects control arm
Site delegation logs ✓

Screening and baseline questionnaire data ✓
Follow-up data at 6 and 12 months from the clinical database ✓
Video-recordings of intervention sessions ✓
Qualitative interviews with therapists ✓
Qualitative interviews with parents/carers ✓
Intervention attendance data ✓
SAE report form ✓

Participant diary ✓
Fidelity of intervention delivery

Fidelity was assessed using the ASI intervention fidelity measure.23 This measure includes assessment
of both structural and process fidelity. The scale demonstrates high content validity according to expert
ratings and high reliability for process elements (total score ICC 0.99; Crohnbach’s α = 0.99).23 Independent
raters were provided with a manual and training on how to score the sessions that they reviewed.
Structural fidelity is defined by:
l the level of therapist training/qualifications, that is the occupational therapist providing the
intervention is certified in sensory integration/SIPT (with a minimum of 50 education hours in
sensory integration theory and practice)
l supervision, that is the therapist has a history of mentorship, with an equivalent of 1 hour per
month from an advanced therapist with 5 years’ experience of providing OT using ASI intervention
for a period of 1 year
l a score of 85 out of 110 across the following four areas – (1) safety of the environment; (2) detail
and content of therapist-held records, including therapist–carer collaboration in relation to goals
set during therapy; (3) physical space and equipment; and (4) communication with carers.
Process fidelity determines whether or not the therapist ensures physical safety; provides sensory
opportunities; helps the child to maintain an appropriate level of alertness; challenges postural, ocular,
oral or bilateral motor control; challenges praxis and behavioural organisation; collaborated in activity
choice; tailors activity to provide appropriate challenge; ensures that activities were successful; supports
intrinsic motivation to play; and establishes therapeutic alliance. This produces a process fidelity total
score out of 100. Each rating reflects the rater’s global impression of whether or not a particular
therapeutic strategy is an intentional part of the therapy being delivered within the observed sample
of SIT. Therapist mentors considered initial assessment, goal-setting and delivery of the intervention
for each therapist by reviewing and providing feedback on the first two video-recorded face-to-face
sessions delivered to any participant.
Where consent was provided, face-to-face sessions were video-recorded. A sample of recorded sessions
in the intensive phase were rated for process fidelity by at least one independent SIT-trained therapist
(based on a randomly selected sample of the full session, of a minimum of 15–20 minutes in duration).
To minimise bias through selecting ‘good’ sessions, the choice of which sessions to rate was made at
random. To ensure that participants had both earlier and later sessions rated, the first session to be rated
was randomly selected between session 6 and 12, and the second session was randomly selected between
session 13 and 20. In the event that a session allocated for fidelity rating was not available (e.g. owing
to the participant not attending), the next available session was rated. To ensure consistency of ratings,
a selection of sessions were rated by multiple independent SIT-trained therapists. Demonstration of
adequate fidelity of intervention delivery was defined as scoring ≥ 80 on the fidelity measure across at
least 80% of sessions sampled.
Adherence
This was the level of intervention received by participants allocated to the intervention arm. An ‘effective’
dose for SIT has yet to be definitively established. However, attending 13 of a possible 20 sessions
(i.e. two-thirds) delivered during the intensive intervention phase was felt likely to indicate sufficient
exposure (based on clinical experience and available literature).
Adverse effects
Serious adverse events were reported from the time of signature of informed consent, throughout the
treatment period up to, and including, 1 month after the participant received the intervention. A SAE is
95
defined as any untoward medical occurrence in a participant who receives an intervention that was not
necessarily caused by, or related to, that intervention (i.e. an AE) and that:
l results in death
l is life-threatening (as defined by GCP)
l requires hospitalisation or prolongation of existing hospitalisation (as defined by GCP)
l results in persistent or significant disability or incapacity
l consists of a congenital anomaly or birth defect
l is a medically important condition (as defined by GCP).
Adverse events that did not meet the criteria of serious were not systematically recorded and none
was reported within the qualitative interviews.
Contamination
The potential for contamination, that is if participants recruited to the control arm received or sought
therapy consistent with SIT or received enhanced/additional support from clinicians aware of their
participation in the trial, is acknowledged. Therefore, there was an examination as to whether or not
the usual care received differed in any way from the expected provision mapped out as a result of the
scoping focus groups (see Chapter 2).
Semistructured interviews were conducted with 30 carers of children and 13 therapists involved in
intervention delivery (see Chapter 9 for full details of qualitative data collection methods). Carers were
purposively sampled to ensure representation of intervention and usual care-only participants, trial region
and a mix of child sex and age. All therapists involved in the trial were invited to take part in an interview.
Data analysis
Quantitative analysis
The approach taken to analyse quantitative data was described in a trial statistical analysis plan.
Recruitment, retention, adherence and safety data are descriptive, and categorical data are presented
using counts and percentages. Process fidelity ratings were completed in accordance with the categories
described in the fidelity tool.23 After viewing a short section of video from a session, raters gave a general
impression of the intervention delivered by responding with ‘yes’ or ‘no’ to the statement ‘This intervention
session is provided by a qualified therapist intentionally applying ASI intervention theory and methods’.
Raters then scored each of the 10 process fidelity items according to whether or not the therapist
demonstrated each item as a key therapeutic strategy in the session. Scores were from 1 to 4, representing:
1. No, I do not think the therapist intentionally uses this strategy.

2. Doubtful, I do not think the therapist intentionally uses this strategy.
3. Probably, I think the therapist intentionally uses this strategy.
4. Certainly, I think the therapist intentionally uses this strategy.
Scores were then calculated to give a total score (Table 41). If the general impression was that the
session was delivered in accordance with ASI, then the expected total score would be ≥ 80%.
Qualitative analysis
Interviews were audio-recorded, transcribed verbatim and anonymised. Interview transcripts were
analysed thematically using a framework approach.66 Two thematic frameworks were created (one for
carer interviews and one for therapist interviews), drawing from the aims of the process evaluation
96

TABLE 41 Calculated process fidelity scoring
Item Multiply by Calculated score
Number of certainly (4) ratings 10
Number of probably (3) ratings 7
Number of doubtful (2) ratings 3
Number of no (1) ratings 0
Total score /100
and a review of transcripts. Data from carer and therapist interviews were coded separately in NVivo
version 12 (QSR International, Warrington, UK). Thematic frameworks were discussed reflectively by
the trial qualitative researchers, and a sample of interviews double coded. For the process evaluation,
the viewpoints of carers and therapists have been collated and presented thematically (see Chapter 9
for full details of qualitative data analysis procedures).
Results
Recruitment of participants and therapists

The CONSORT (Consolidated Standards of Reporting Trials) flow diagram (see Figure 5) gives a detailed
breakdown of recruitment. A total of 258 carers contacted the study team to express an interest in
taking part. Of those 258 carers, 24 (9.3%) were not eligible at referral. A further 84 carers did not go
any further for the following reasons:
l no further response (n = 61)

l not interested in participating (n = 23).
Screening appointments were held with 150 carers and children. Three children (2%) were screened as
ineligible after not meeting inclusion criteria (other than SPD). Nine children did not progress for the
following reasons:
l no further response (n = 4)
l not interested in participating (n = 1)
l eligible and consented but then withdrew immediately (n = 4).
A total of 138 children were randomised into the trial (i.e. 92% of those screened and 53.5% of those
who expressed an interest in taking part).
Participants were probably representative of the wider population of children in primary education
with a diagnosis of autism presenting to services. The majority of participants were male (79%) and
white British (88%) (see Chapter 6 for a description of baseline characteristics).
Recruitment of therapists to deliver the intervention occurred in stages as new health boards and clinic
sites were opened. From August 2017, just one therapist was delivering the intervention to participants
in South Wales (at a clinic in Cardiff University). By November 2017, a further five therapists across three
South Wales university health boards (i.e. Hywel Dda University Health Board, Aneurin Bevan University
Health Board and Cardiff and Vale University Health Board) started delivering the intervention. One
occupational therapist was available to start in Cwm Taf University Health Board in February 2018,
with another occupational therapist starting in May that year. A therapist at a private clinic in Cornwall
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started delivering the intervention in May 2018, with another therapist starting at the same clinic in
July 2018. Given that each therapist could deliver the intervention to only one or two children at a time
(given their NHS obligations), extra sites and therapists were recruited. In May 2019, a further therapist
was recruited in Swansea Bay University Health Board, another therapist in Aneurin Bevan University
Health Board and four were recruited at the Pace School in Buckinghamshire. Therapists’ capacity to
see multiple children simultaneously depended on their working hours, leave and other commitments.
Therapists were not directly involved in trial recruitment but did refer potential participants to
the trial team. Some therapists reported that they had difficulty identifying potentially eligible and
willing children to take part, despite some being involved in publicising the trial through schools or
presentations to professionals. One therapist thought that the trial criteria were too strict, particularly
relating to age, as children either side of the age range may have benefited from the intervention.
Carers were asked during interviews where they had heard about the trial. A variety of sources was
reported (Figure 26), most commonly via professional recommendation (note that one carer did not
provide this information).
The main reasons that carers gave for taking part in the trial were that they hoped that their child
would receive the intervention and that they wanted to improve support for children with autism and
SPDs in the future. Some parents specifically wanted to pursue SIT for their child (having heard about
it on courses, through their own research or via recommendations from friends), as they thought that
it would be beneficial. It was often mentioned that carers and their child had received little or no
support and, therefore, carers were happy to try anything that might help (carer interviews):
When we went in to [the trial it was] sort of like, not . . . a last resort, but like oh my God, something
has got to help . . . I just think it’s really sad that there’s just nothing out there . . . and . . . maybe, maybe
you know, in years to come, maybe this might be something that benefits everybody. So although it’s
benefitting you, you’re also helping to benefit others.
P219, intervention arm
Recommended by professional
Child’s school
Autism show
Recommended by friend
Letter from Cardiff University
Facebook
Local autism group
0 2 4 6 8 10 12
Number of carers
FIGURE 26 How parents heard about the trial.
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Most carers said that they had no concerns about their child taking part in the trial, although several
worried that their child might be allocated to the control arm, meaning that they would not get the
help that they needed. One carer was concerned that the intervention may not benefit their child, that
is they would have ‘put him through’ appointments for nothing. Another carer was worried in case
they were not allowed to stay with their child during appointments. One carer was concerned about
anonymity owing to their profession, but was reassured when they were told that data would be
labelled with participant numbers rather than names. Therapists did not report any concerns being
expressed directly to them by carers.
Retention
Participant retention
The primary outcome time point was 6 months post randomisation, and these visits were all completed
by 7 May 2020. Of 138 participants, 107 (77.5%) provided follow-up data at this time point. Twenty-nine
participants were lost to follow-up and there were two withdrawals. Twelve-month follow-ups were
completed on 17 December 2020. Of 138 participants, 96 (69.6%) provided data at this time point.
Forty participants were lost to follow-up and there were no additional withdrawals.
Therapist retention
Of the 16 therapists delivering intervention, two were able to see only one child each before having to
withdraw their involvement in the trial for personal reasons.
Fidelity of the intervention
Structural fidelity
Structural fidelity includes the level of therapist training/qualifications and supervision, coupled with
achieving a score of 85 out of 110 across four areas (see Other areas).
Level of therapist training/qualifications

All SenITA trial therapists had completed postgraduate modules of ≥ 50 hours of face-to-face teaching,
plus the hours to complete written assignments, and most therapists had completed two, three or four
postgraduate modules.
Supervision
In the UK, there is no established SIT mentoring system. Therapists typically received mentoring of
at least four sessions for completion of their postgraduate modules, followed by monthly mentoring
sessions with an experienced occupational therapist. Therefore, we compensated by ensuring that
mentoring occurred throughout their intervention sessions.
Other areas
Other areas included:
l safety of the environment

l detail and content of therapist-held records, including therapist–carer collaboration in relation to
goals set during therapy
l physical space and equipment
l communication with carers.
Some clinics required additional equipment to be purchased to meet fidelity; however, all clinics met
structural fidelity criteria prior to initiating therapy (all scores were > 85, with a range from 96 to 110).
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Total fidelity scores

The outcome of interest for process fidelity was the number of therapists scoring at least 80 out of
100 on the process fidelity measure for at least 80% of sessions rated. Ninety-six sessions were rated,
yielding 156 total fidelity scores from independent raters for 46 different intervention participants
who were delivered SIT by 12 different therapists. The mean score across all 156 ratings was 90.1
(SD 13.1). Technical problems meant that recordings from four therapists were not available to be rated.
Multiple ratings
Four independent raters scored process fidelity for 96 sessions. All raters scored the same 17 sessions
(17.7% where target had been between 15% and 20%) to assess the comparability of their ratings and
were then allocated more sessions on an individual basis. The majority of sessions were scored by one
rater (Table 42). Averages were taken where sessions were rated by more than one rater and,
therefore, had multiple scores.
Fidelity threshold
The SIT delivered in the SenITA trial met fidelity, with 10 out of 12 therapists scoring, on average, at
least 80 out of 100 on the process fidelity measure for at least 80% of each of their sessions. Two
therapists (i.e. therapists 7 and 8) scored below this threshold (Tables 43 and 44). Rater 2 consistently
scored both therapists lower than other raters for these sessions, which skewed the average. Both
therapists had mentors to support them further and improved in delivering the intervention. It was
noted that, although their clinic space met structural fidelity, it was also one that had limited flexibility.
TABLE 42 Number of ratings per session
Number of ratings Total number of sessions (n = 96) Percentage
1 73 76
2 2 2
3 4 4
4 17 18
TABLE 43 Breakdown of scores for therapist 7
Rater 1 Rater 2 Rater 3 Rater 4
Average Score from Score from Score from Score from

PID Session score rater GIS rater GIS rater GIS rater GIS
402 6 49.25 79 1 20 0 55 ? 43 0
402 7 76.0 76 1
402 13 85 85 1
402 15 77.75 79 1 47 0 100 ? 85 1
408 12 91 91 1
408 17 94 94 1
414 11 71.0 71 0
414 13 86 86 1
GIS, Global Impression Score; PID, participant identification number.
Note
? denotes score not provided by rater.
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TABLE 44 Breakdown of scores for therapist 8
Rater 1 Rater 2 Rater 3 Rater 4
Average Score from Score from Score from Score from

PID Session score rater GIS rater GIS rater GIS rater GIS
403 7 95.5 97 ? 94 1
403 13 75.75 76 1 36 0 100 1 91 1
411 6 64.0 64 0
411 19 53.0 53 0
GIS, Global Impression Score; PID, participant identification number.
Note
? denotes score not provided by rater.
Global Impression Score

Along with 156 process total fidelity scores from multiple raters, 144 (92.3%) participants achieved
a Global Impression Score of 1 (i.e. ‘yes’), nine (5.8%) participants were scored as 0 (i.e. ‘no’) and three
(1.9%) participants were missing this score. Even where total fidelity scores were < 80, Global Impression
Score was mostly assessed as meeting sensory integration criteria.
Adaptations made by therapists

Therapists tailored intervention sessions to the needs of each child. Therapists had to adapt to working
with children with autism, for example by providing more coaching/prompting and dealing with avoidance
behaviour. In terms of specific changes made to trial processes, two therapists adapted the wording of the
COPM to make it more child-friendly, one therapist asked for more time for discussions with parents and
a second therapist conducted assessments in shorter blocks over a larger number of sessions.
Acceptability
Overall experiences of the trial

All carers agreed that if they were to go back in time, they would be happy to take part in the SenITA trial
again. For some of those carers allocated to the control arm, this was because it would give them another
chance to possibly receive the intervention. Carers in the intervention arm were very enthusiastic about
the trial and said that they would ‘definitely’ participate again, as the intervention had helped their child:
Oh definitely yeah, definitely. Without a shadow of a doubt, like I’d love to take part again, I know I can’t
. . . honestly definitely it was totally worth it, I’d recommend it 100%.
Carers reported that members of the trial team who they encountered were friendly and understanding.
Carers felt that the trial was explained very well and did not feel pressured to take part. The reminder text
messages were useful and trial appointments were flexible. Some carers explained that just being selected
to take part in the trial was positive, as they felt that their child’s difficulties had been acknowledged:
It’s been really good and [all the trial team have] been really kind and really understanding and really patient.
However, some carers reported a lack of communication from the trial team. For example, one carer
in the control arm reported that they had not been told which group their child was in and did not
realise that their involvement in the trial had started until they got a reminder 4–5 months later to
fill in the diary. Another carer had been allocated to the intervention arm, but their child had received
no therapy after 6 months and they had not been told when it was going to start.
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Trial information
Carers felt that they were given the right information about the trial before taking part and had
the opportunity to ask questions. Some carers commented that there was plenty of information
provided and, therefore, they knew exactly what would happen and what would be expected of them.
Information was easily understood and well explained by trial staff. One carer felt that they had been
given too much information, but another carer said that the information did not fully explain what
would happen in the intervention sessions. Two carers had not immediately realised that they had
been allocated to usual care, which caused some confusion. One carer appreciated that plenty of time
was given to decide whether or not to participate and that consent was checked at several stages:
It’s been brilliant . . . I felt like I was always kept informed and really sort of, felt very much as though it
was my choice, like I was never sort of bullied into it, like you’ve been offered this, it’s a golden opportunity,
you should do it. It was never felt like that, it always felt like you know, you can stop this at any time . . .
So I felt like the overall explanation of it and what was going to be involved, was explained really well.
Most carers said that taking part in the trial had met expectations or (for those in the intervention arm)
had been better than expected. The time commitment was mostly as anticipated. Two carers said that the
trial had taken more of their time than they expected in terms of travelling to appointment sessions.
Trial appointments
Convenient and flexible appointment times were offered when possible. Some carers in the intervention
arm mentioned having difficulty because all sessions were during school/working hours. In some cases,
schools were happy for children to attend intervention sessions during school time, as they felt that it
would benefit the child; however, other schools were less supportive. For example, one carer reported
that their child’s school felt that the intervention was responsible for a deterioration in behaviour and,
therefore, they had experienced issues with requesting time off school for trial appointments.
Although sessions were held in a convenient location for some carers, others found the trial to be a
big commitment that was difficult to fit into their lives, mostly owing to travelling times. However, all
carers were committed to attending appointments, as they felt that they were beneficial. Several
parents mentioned parking issues at appointments. One parent said that they had been given no
consistent time and date for sessions, and sometimes could not contact the therapist and, therefore,
had been unsure of what was happening:
It’s an hour and a half to the session . . . an hour and a half home, and that was twice a week. So it was
a big financial investment to, you know, fund the fuel alone, and then with my time . . . It was a massive
investment in family life . . . I would pick him up at 12 o’clock on the dot. He’d have lunch in the car,
and we’d just about get to [the session] for 1.30.
Completing trial measures
Assessments
Two carers commented that assessments were a positive experience, as they were play based and the
assessor had a good rapport with their child. One carer found that their child had already completed
one of the tests and had remembered the answers, and so the results may not have accurately reflected
his ability. One carer said that it would have been helpful to have been given a report of the test results,
as this would have been useful for other professionals working with their child.
Several therapists found the SIPT demanding and difficult to conduct because of the length of the
assessment and the avoidance behaviours displayed by children, which mean that it was not always fully
achieved. One therapist was able to conduct the assessment jointly with a colleague, which was helpful.
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Another therapist had to ask carers to help. Several therapists conducted the assessment over two or
more sessions, as they felt that it was too long for children to complete in one sitting. The following
specific problems were reported by individual therapists:
l Conducting the assessment at the end of the intervention was problematic, as children were
disappointed that they would not be having a therapy session, particularly where the assessment
was being conducted in the therapy room.
l Starting with a standardised assessment before building rapport with the child and parents
was unhelpful.
l Some children would not engage with the copying exercises, as they had been told at school that
it was wrong to copy and took this very literally and, therefore, the assessment may not have
accurately reflected their ability.
Despite these issues, one therapist reported that assessments provided a useful starting point for
planning the intervention.
Questionnaires
Carers found the questionnaires long, but relatively easy to complete. When carers did not understand
how to interpret some of the questions, trial staff provided an explanation. Carers commented that a
lot of questions seemed repetitive, with the same topic revisited several times with slightly different
wording. Some questions were not appropriate for the age of the child, for example asking whether or
not a 7-year-old took drugs. One carer found questions intrusive, for example those asking about their
own personal relationships and mental health.
Some carers found the questionnaires and assessments useful, as they highlighted their child’s needs.
Conversely, several carers found the questionnaires and assessments upsetting to complete, as they
focused on all the things their child could not do:
It was . . . really long winded . . . mentally and physically exhausting . . . It’s like when you go and do a
[Disability Living Allowance] application . . . you’ve got to take your child at their worst ever possible day
and write it down . . . you want to spend your life . . . focusing on what your child can [do], despite their
difficulties, not what they can’t do, and I think it is a bit depressing like that.
Trial diary
Completing the trial diary was problematic for most carers. Some carers had difficulties logging on
to fill in the diary online and, therefore, did not fully complete it. Other carers forgot to complete it
regularly or did not have time to do so, and one carer commented that they did not seem to be able
to go back to fill in previous weeks that they had missed. Several carers did not realise that they
had to complete a diary. Some carers in the control arm felt that there was little incentive for diary
completion, particularly where their child had received few appointments and, therefore, there was
not much to fill in. Only a minority of carers completed the diary online with no issues.
Carers reported that it was useful having text reminders to complete the diary and found it much
easier replying to the texts than completing the diary. One carer suggested that it would have been
better if the information could all have been provided via text.
Data input
Therapists found filling in information after each session repetitive and ‘laborious’. One carer felt that
it was a ‘tick-box exercise’ that was not helpful with planning future sessions, although others found it
useful. Two therapists were not sure what to report under the different reflective headings and would
have found it helpful to have more guidance.
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Randomisation
Most carers had a good understanding of the purpose of randomisation. One carer had not initially
realised that there would be two groups of children and thought that all would receive the intervention.
Although all parents hoped that their child would be in the intervention arm, they appreciated the need
for randomisation. Those carers allocated to the control arm were disappointed, but happy to continue
their involvement in the trial. One carer suggested that the intervention could have been offered to
usual-care children after the trial had been completed so that all children would have had the chance
to benefit from it.
Trial information technology

Most therapists experienced information technology (IT) issues (summarised below) and found the
technical aspects of the trial time-consuming. Several therapists found that they needed technical
support and for some this was because they did not have previous experience of using an iPad.
IT problems encountered by therapists included the following:
l The camera had limited memory and could store only 60 minutes of footage and, therefore,
videos often needed to be transferred onto the iPad, which was problematic. The 60-minute limit
meant that conversations after the session with carers (which would have been useful to capture)
were missed.
l The camera battery sometimes ran out during the sessions.
l Some mentors had difficulty accessing the session videos.
l There was no internet at one clinic and so information could not be input or accessed directly,
and data had to be uploaded offsite.
l The connection between the camera and the iPad sometimes did not work.
l Some iPads and cameras were shared between therapists, which caused difficulties with planning.
l The internet connection at one clinic was unreliable and uploads had to be repeated.
One therapist identified that recording the sessions using a static camera on a tripod meant that,
unless they had an assistant to move the camera around, parts of the sessions were not necessarily
visible on the recording. Several therapists reported that they needed an extra person to manage the
recording of sessions.
Support for therapists

Therapists generally felt supported by the trial team, reporting that they responded quickly to
any problems raised. Most therapists found the data collection manual useful, clear and easy
to follow. As mentioned above, some therapists needed additional technical support with the IT
aspects of the trial.
Intervention delivery
What worked well?

Carers appreciated that the intervention was tailored to their child’s needs, abilities and
interests. Carers commented that therapists had good ideas of how to make the sessions
engaging, put a lot of thought into planning them and went out of their way to help. For example,
therapists provided carers with ideas of activities to do at home and strategies to deal with
particular situations:
The OT [occupational therapist] was absolutely amazing. Like if I needed any advice on anything I could
do with the certain situations, she gave me a solution. Again she suggested books and different activities
I could do and that as well.
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Therapists were very engaging and positive, and the equipment was varied; therefore, children enjoyed
the intervention and were keen to go to the sessions. Carers were particularly positive about their
child being able to have direct one-to-one therapy, which they felt had been lacking in usual care.
Carers commented that this approach meant that their children fully engaged with the activities:
I didn’t expect to get so much out of it . . . or for [child] to enjoy it . . . I could hear from that room, sitting
outside and she was laughing, and it was an actual, it wasn’t a put-on laugh that she does sometimes.
So that was really nice just to hear her enjoying herself really, she was just so relaxed and comfortable,
it was lovely.
One carer appreciated that the therapist spent time at the end of each session to ensure that their
child was calm when they left. One carer was pleased that their child had a certificate at the end of the
sessions, as he had never received one before and so it meant a lot to him.
Therapists enjoyed being able to spend longer with one child than would be possible in usual care.
This longer time enabled therapists to build a good relationship with children and carers. Most therapists
appreciated the opportunity to provide SIT, as it was rewarding to be able to deliver sessions that children
really enjoyed and engaged with. Several therapists mentioned that it was positive being able to provide a
therapy that was child led:
It’s wonderful to be able to . . . really get to know the child and the parents really, really well . . .
as part of my NHS [work], you’d be lucky if you saw a child once a week for a few weeks at a time.
T203
I think the fact that it’s child led makes it accessible, makes it engaging.
T206
What did not work well?

Most carers said that there were no negative aspects to the intervention or that the only downside
was that it had to finish. Therapists found delivering the intervention intense and tiring. For example,
it was difficult to think ahead all of the time while engaging with the child. It was also challenging to
come up with new play ideas for a relatively long block of sessions, particularly because children
tended to have limited imagination because of their autism. Some children had complex needs in
addition to their autism diagnosis, for example pathological demand avoidance, which made it
challenging to engage them in activities:
Thinking on your feet constantly . . . you’d have to think in terms of what, what equipment you can maybe
adapt or change to make sure it’s just the right challenge so then they would achieve success in order for
them to be motivated in your session . . . You’re constantly thinking about that. You’re constantly analysing.
You’re constantly thinking ahead . . . it’s multitasking really.
T202
Some therapists found that they had insufficient time to engage with carers (e.g. some carers needed
help to learn how to play with their child, and others needed support themselves or the chance to
discuss issues arising). Therapists reported that in usual care they would typically have more time to
talk to carers and were also able to go into the child’s school.
Some therapists identified that using a pure sensory integration approach was restrictive, as they felt
that some goals could have been achieved more quickly via other more task-specific approaches.
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Suggestions for improvement of the intervention

Several specific suggestions were made by individual carers who said that it would have been useful to
have had:
l a written report at the end of the intervention to pass onto their child’s school
l information on where to buy sensory equipment
l more suggestions of activities to do at home to help sustain their child’s progress
l more time after the sessions ended to be able to contact the therapist so that they could ask for
advice if things started to go wrong
l more clarity of what to focus on at home each week.
Therapists suggested that more time to engage with carers or being able to visit the child’s school
would have been helpful:
I think one of the things that . . . was tricky, because it didn’t feel like the circle had been closed really,
was not being able to go into schools. I know we could speak to schools over the phone, but I think
actually having someone from the school . . . coming on some of the sessions, or me to visit the school
[would be useful] . . . because some of the issues were with school.
T210
Length of intervention
Around half of therapists felt that the intervention was too long in terms of number of sessions,
as therapists struggled to come up with new ideas to fill all sessions and some children (particularly
those who were more able) made no more progress in the last few sessions. Other therapists felt that
it was the right number of sessions or that some children would have benefited from further sessions.
Some carers also felt that it would have been helpful if sessions had carried on for longer. For example,
one carer said that they were still seeing improvements when sessions finished and several carers
found that changes were not sustained once the intervention had been completed:
For me, as a therapist, it can feel like you’re . . . treading water for those last four sessions in a way.
But [with some children] I feel like they’re still making changes.
T211
Some therapists felt that having sessions twice per week was helpful in terms of consistency and
building rapport and enabled changes to be made more quickly. However, one therapist suggested
that this was too intense. Some therapists found that the transition to less-intensive sessions worked
well where children were ready for it, and that it was helpful in providing a more gradual end to the
intervention. However, other therapists found that it disrupted the flow and consistency of sessions
and was a big change that could have been more gradual. Several carers agreed that the ending of
regular sessions was too abrupt (e.g. going from two sessions per week to once per fortnight) and
difficult for their child to cope with. One carer suggested that sessions could have been tapered down
more gradually towards the end.
Most carers felt that they started to see changes in their child about halfway through the intervention
sessions. Other carers said that they felt that there was a more gradual change throughout the intervention.
Therapists agreed that changes seemed to occur around the halfway point.
Therapist time allocation

Therapists felt that there was insufficient time allocated for the delivery of the trial. Time allocation
had been calculated based on length of each session, with additional time for intervention planning and
the write up of sessions. Therapists’ time was covered by NHS excess treatment costs and, therefore,
there had to be a standard time allocation for all. Excess treatment costs had been appropriately
costed, yet most therapists reported that the trial had taken much more of their time than they had
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anticipated, which made their workload difficult to manage. Some therapists had had to work unpaid
and one therapist found it stressful negotiating their time with their manager and the trial team.
For example, the technical aspects (e.g. recording and uploading the sessions) took up a lot of time,
sessions were time-consuming to plan and set up, and there was also administrative work, such as
booking appointments and inputting data, which some felt had not been fully accounted for. There
was also no time allocated for discussions with carers, which therapists felt would have been helpful.
Some therapists found that assessments took longer than allocated. This all meant that some therapists
had to complete trial-related work in their own time:
It was really difficult to manage kind of doing clinical research within the demands of . . . my NHS day
job . . . that was probably one of the hardest things I would say, being able to manage the time that the
study required, which was way above what I guess was ever anticipated or described to us.
T205
Goal-setting
Most carers found goal-setting straightforward, although some carers reported that, as there were
multiple issues that they wanted to tackle, it was difficult to prioritise which to focus on. One carer
found setting realistic goals difficult, as they were not sure how much their child would be able to
achieve in 6 months. Another carer pointed out that, as they had become so used to their child’s
difficulties in everyday life, it was difficult to identify what they needed to work on. Some children
were able to set realistic goals for themselves; however, one child wanted to set goals based on what
his peers were able to do, which he would have found difficult to achieve.
Therapists reported that carers needed prompting to set more specific goals that were functional,
measurable and realistic, as they tended to come up with general objectives, such as wanting their child
to be less aggressive. Children were mostly not able to be involved in goal-setting and, therefore, some
therapists did this over the telephone with carers. In some cases, goals set by carers did not necessarily
relate to what their child wanted to achieve. Some carers needed prompting to think of goals, and
therapists reported that the COPM was useful in helping them think through their child’s difficulties.
Potential for the adoption of sensory integration therapy as usual care

All carers thought that SIT should be available as usual care because it had benefited their child and because
of the lack of support available for children with autism and SPDs. All carers would ‘definitely’ recommend
the intervention to others because it had helped their child, and some had already recommended it.
Most therapists felt that if there were sufficient resources, SIT (at the intensity offered during the trial)
should be available as usual care for children where appropriate. Therapists saw that SIT made a big
difference to some children and enjoyed being able to deliver one-to-one therapy tailored to the child:
I was absolutely staggered by the outcomes that we achieved.

T201
[SIT is] really much more targeted and . . . it really felt as though we were getting to the bottom of and
really kind of problem-solving these . . . difficulties . . . with the child and with the family . . . I didn’t feel
as though these children are going to need much more beyond this, whereas the usual care feels like,
you kind of wonder when they’ll be back.
T210
However, some therapists felt that a sensory integration approach alongside other approaches would
be more helpful in achieving children’s goals:
I think that sensory integration therapy is just a tool in the occupational therapy toolbox . . .
I don’t think it’s the first port of call.
T212
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If the intervention were to be adopted as usual care, therapists identified that considerably greater
resources would be needed in terms of room capacity and funding for increased staff time and
specialist training. Therapists suggested that research demonstrating the effectiveness of SIT would
be needed to convince managers and funders that it should be implemented more widely. Therapists
anticipated that waiting lists for therapy would increase because there would be great demand for it.
Adherence
Overall, 54 (78.3%) participants allocated to the intervention arm received at least 13 SIT sessions
during the intensive stage. The median number of SIT sessions received was 20 (IQR 16–21). A full
breakdown can be found in Chapter 6.
Adverse events
There were no SAEs during the trial. One AE was reported to the trial team by a therapist as a SAE;
however, it was clear this did not meet the criteria of ‘serious’ as laid out in the reporting guidance.
Contamination
Changes during trial participation

Most carers reported that there had been no changes to the support that their child received during the
trial period. However, one child allocated to usual care had received intervention consistent with SIT,
one child started accessing support from local charities (after not meeting fidelity requirements of SIT),
one child had started a specialist school and one child had received a statement of special educational
needs. Six children had started new extracurricular activities (mainly sports) while participating in the trial.
Impact of the trial on therapists’ practice

Most therapists said that their approach to delivering usual care had not changed because of their
involvement in the trial. For some therapists, this was because they did not have the time to implement
any of the sensory integration approaches in their usual practice. Two therapists felt that they had
increased their knowledge of sensory integration and one carer had shared some of what they had
learnt with colleagues and carers.
Contextual factors
Carer understanding of sensory integration therapy

Although therapists found it easy to explain the trial to carers, explaining the intervention was more
complex. Therapists felt that carers had a basic understanding of SIT, but that not all carers fully
understood the approach, which affected the extent to which they engaged with the therapy (see
Chapter 9 for further details).
Clinic space and equipment

The main facilitator to intervention delivery reported by therapists was having a good clinic space with
a variety of equipment. Several therapists mentioned that it was useful having an assistant to help set
up the room for each therapy session.
Therapists appreciated having a variety of equipment to work with, which was helpful for intervention
delivery, as sessions could be adapted to challenge each child. However, sessions were time-consuming
to plan because they were tailored to individual children and intervention sessions took longer to set
up than usual-care sessions (typically 15–30 minutes to set up, with the same time required to put
the equipment away). Some therapists had a dedicated therapy room that was partially set up, which
enabled them to prepare for sessions more quickly, as only minor changes had to be made. However,
other therapists had to set the room up from scratch each time, which was physically challenging, for
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example setting up heavy suspended equipment. Those therapists who had a technician to help them
set up said that this was extremely helpful and, in some cases, necessary:
[You need] time . . . as well to think . . . what am I hoping to achieve in this session and how am I going to
set the room up to achieve what I want to, so it’s all that mental thinking that you’re doing as well as just
putting the equipment up.
T203
Changeovers could also be problematic, for example the room had to be cleaned between sessions if
therapists used messy play.
Therapeutic relationship with the child

Carers commented that therapists put a lot of effort into engaging with their child and were able to
develop a good rapport and working relationship, which enabled rapid improvements to be made:
She just loved all of it . . . because I think [the therapist] just worked really hard to get that, like that
connection with her.
Therapists agreed that being able to see one child over a number of sessions enabled them to build
a good rapport. The fact that the intervention was enjoyable for children also helped with their
therapeutic relationship:
It’s a therapy that I feel is great because the kids love to engage in it and feel empowered by it . . .
when you’ve built up those relationships you get that ability to be able to push them a little bit, to
challenge . . . their sensory systems that particularly need to be challenged . . . if you’ve got the child on
your side then it feels like you can actually work with them and challenge them and move them forward.
T206
Support and training for therapists

Most therapists felt well supported to deliver the intervention. However, therapists identified that it
would have been useful to have an extra member of staff to assist in therapy sessions, for example
to help with the recording, provide technical support or assist with setting up and taking down the
equipment. Some therapists did have this support, which was invaluable. One therapist found
the videos of the sessions helpful to look back on, although this was carried out in their own time,
but others said that they did not have time to do this.
In general, therapists found that intervention training was sufficient. The session to observe therapy
and assess whether or not it met the fidelity measures was described by one therapist as particularly
useful. Some therapists already delivered SIT as part of their usual practice and it was felt that those
therapists who had not may have struggled. Some therapists felt that they were relative ‘novices’ in
delivering SIT and one therapist reported feeling out of their depth and lacking knowledge for the
more analytical aspects.
Mentorship was described as very helpful, with mentors providing advice and guidance to help with
the planning of future sessions, including discussing specific issues experienced. However, one therapist
did not receive mentorship and several therapists started mentorship sessions later than intended, for
example not until after they had seen their first child as part of the trial. Some therapists experienced
technical difficulties sharing session videos with their mentor. One therapist had useful support from
a colleague who was experienced in SIT and another therapist said that it would have been useful if
colleagues were delivering the therapy at the same time so that they could have discussed ideas.
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Not all therapists used the trial Facebook group, some because they were not confident in using IT
and others because they were not aware that there was one. For those therapists who did use it, they
reported that the group was not very active. Therapists suggested that it would have been helpful to
have group discussions with peers also delivering the intervention.
Conclusions
The process evaluation demonstrated that recruitment of participants and therapists and delivery of
intervention all met required thresholds. Recruited participants were also probably representative of
the population with autism presenting to services. Findings were consistent with those from the internal
pilot in that recruitment criteria were met and there was little difficulty in generating expressions of
interest. Participant recruitment into the study was, in part, tempered by therapist availability. Retention
of participants was good, as was retention of therapists, although practicalities of juggling NHS caseloads
with the trial meant that the overall trial recruitment period and, therefore, delivery of intervention was
longer than initially anticipated.
Data show that structural and process fidelity were high. In cases where process fidelity was lower
than anticipated, therapists were given extra support through mentoring. In these cases, it is possible
that some fidelity elements may not have been present in the video clip selected or reflected poor
agreement among raters.
Carers generally found trial processes acceptable and enjoyed being part of the trial. However, there
were areas where adaptations could be made. Both therapists and carers reported that entering data
online was not particularly easy. In the case of reporting diary data, carers generally struggled with this
and often forgot or had difficulty using the online system. In their normal practice, therapists were
used to taking hard-copy notes and, therefore, found an online system difficult to use during sessions.
Therapists felt that there were numerous technical processes involved as part of their role in collecting
data (e.g. setting up cameras, uploading data and finding WiFi), which added to their burden. However,
therapists generally felt well supported by the trial team who were able to resolve queries in real time.
Overall, adherence to the intervention was high, although, on a practical level, carers sometimes found
it difficult to fit the intensive phase of the intervention in with other events in their personal lives
(e.g. school, holidays and leave from work). The intervention was safe, with no SAEs reported. There
was minimal contamination in the control arm and families allocated to SIT did not report receipt of
any other significant intervention or contact with services.
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Chapter 9 Carer experiences of usual

care, and carer and therapist experiences
of the intervention
Methods
Overview
Semistructured interviews were carried out with a sample of carers and therapists who delivered
the SIT intervention. Before taking part in an interview, carer participants were asked to complete a
timeline of the support that they and their child had received, which was used to facilitate discussion
of their experiences. The aims of the qualitative study were to explore the (1) support experiences of
families (outside the SenITA trial, i.e. usual care) and (2) perceived impact and clinical effectiveness
of the SIT intervention for children with autism and SPDs.
Participants
Interviews were conducted with 13 occupational therapists who delivered the SIT intervention and
carers of 30 children enrolled in the SenITA trial (Table 45).
TABLE 45 Carer interviews: participant characteristics
Characteristic n
Sex of child
Male 23
Female 7
Child age group (years)
5–6 6
7–8 9
9–10 8
11 7
Child ethnicity
White British 23
Mixed ethnic background 2
White other 2
Not disclosed 3
Trial arm
Intervention 20
Control 10
Trial region
Wales 20
Cornwall 6
North Buckinghamshire 4
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EXPERIENCES OF USUAL CARE AND OF THE INTERVENTION
Sampling and recruitment

For the carer interviews, participants were purposively sampled from the SenITA trial database, aiming
for variation in terms of sex of child and age. Two-thirds of children in the interview study were
recruited from the intervention arm to enable a more in-depth exploration of the perceived impact of
the SIT intervention.
Carers were invited to take part in an interview once their child had reached the 6-month follow-up
point of the SenITA trial. A qualitative researcher contacted carers by telephone or e-mail (in accordance
with their stated contact preferences) to ask if they would consider taking part in an interview. Those carers
who agreed were sent an information pack, which included a PIS, a template timeline with completion
instructions and several coloured pens. Potential participants were re-contacted after approximately 1 week
to check whether or not they would be willing to participate. Fifty carers were purposively sampled
from the trial database and 30 agreed to participate, giving a response rate of 60%. Of the 20 carers
who were sampled but did not participate, 15 could not be reached to discuss participation, three declined
to take part as they had insufficient time and two said that they did not wish to take part in an interview,
but did not give a reason.
All therapists (n = 16) who delivered the SIT intervention were e-mailed by the qualitative researcher
to ask if they would be willing to participate in an interview once they had delivered all intervention
sessions for at least one child as part of the trial. The e-mail included a participation information sheet
with details of the interview study. Thirteen therapists agreed to take part in an interview and three
could not be reached to discuss participation, giving a response rate of 81%.
Study materials
Separate sets of interview questions for carers and therapists were developed by qualitative researchers,
with input from the SenITA Trial Management Group and parent/carer advisory group. Carer interview
questions focused on experiences of the SIT intervention (for participants in the intervention arm only),
if and how the intervention had affected their child’s behaviour and the implementation of activities or
strategies suggested by the occupational therapist (for carers of children in the intervention group) and
experiences of support for their child’s autism outside the SenITA trial (for all carers). Therapist interview
questions focused on experiences of delivering the SIT intervention, perceptions of the impact of the
intervention and the receptiveness of carers to suggestions of activities or strategies. Both sets of
interview questions also covered carers’ and therapists’ experiences of trial processes (see Chapter 8 for
related findings).
Before taking part in an interview, carers were asked to complete a template timeline of the support
that they and their child had received. Carers were provided with timeline completion instructions
that requested them to include any key events in their child’s life and the different forms of support
experienced for their child.
Data collection
Interviews were conducted at a mutually convenient time and in accordance with participant preferences,
that is either face to face at the participant’s home/workplace or over the telephone. Most therapist
interviews took place over the telephone (n = 10), whereas most carer interviews were face to face (n = 19).
Therapist interviews lasted between 27 and 58 minutes (mean 40.2 minutes, SD 10.6 minutes). Parent/
carer interviews lasted between 12 and 86 minutes (mean 38.0 minutes, SD 17.6 minutes). With the
consent of participants, all interviews were audio-recorded. Around half (n = 13) of carers completed
the timeline template prior to the interview, whereas others said that they had insufficient time or had
not remembered to do so. Following the interview, all carer participants were given a £10 shopping
voucher to thank them for taking part.
Analysis
All interviews were transcribed verbatim and analysed using a framework approach66 by two qualitative
researchers. First, transcripts were read in full and key themes were identified in accordance with the aims
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of the qualitative study. These key themes addressed both aspects of the study, that is the support
experiences of families (carer interviews only) and the perceived effectiveness of SIT (interviews with
therapists and carers of children in the intervention arm). Transcripts were then re-examined and
emergent subthemes were identified within each main theme by the first qualitative researcher. After
discussion with the second qualitative researcher, a thematic framework was developed and entered
into NVivo. All interviews were then coded in NVivo by the first qualitative researcher, with 10% of
transcripts coded by the second qualitative researcher to enhance reliability. Tables were created to
summarise the experiences of each interview participant, corresponding to each theme and subtheme.
The inclusion of illustrative quotes enabled the validity of findings to be reviewed. Both qualitative
researchers met to discuss the identified themes and discussion continued until consensus was reached.
Results: part 1 – support experiences of families
Timelines completed by carers gave an overview of the support received by families. There was
wide variation in experiences. However, in the early years of children’s lives, the involvement of
professionals followed a similar pattern. Carers noted that they first became aware of signs that
their child might be autistic at the age of 1 or 2 years, when the main professional point of contact
was their health visitor. Early concerns were raised with the health visitor, but often dismissed.
Professionals tended to notice children’s speech difficulties at an early stage, resulting in support
from speech and language therapists and/or paediatricians. When children started formal education,
this appeared to initiate additional support, for example from psychologists, occupational therapists
and charitable organisations. However, in most cases, specialist autism support was not provided until
children reached the later years of primary school. Some support provision – for example the EarlyBird
programme (i.e. a specialist parental support programme) provided by NAS – could be accessed only
when a child had been diagnosed with autism. After receiving a diagnosis, there was much greater
variation in service provision and, aside from the EarlyBird programme, no clear pathway to support.
Three key themes were identified from interview transcripts and timelines, each with three emergent
subthemes (Table 46). Each theme is discussed in the following sections, supported by participant quotes,
which are labelled with participant identification numbers.
TABLE 46 Themes and subthemes: support experiences of families
Main theme Subtheme
Support provision Variation in support received
Support changes since diagnosis
Carers’ learning and research
Usefulness of support Generic vs. specialist
Statutory vs. voluntary
Professionals vs. experts by experience
Unmet support needs Barriers to accessing support
Gaps in support
Limits in support
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Support provision
Variation in support received

The support received varied widely. Eight families had accessed between one and three forms of support,
whereas nine families had received support from ≥ 10 professionals or organisations. No differences in
support accessed were observed relating to the sex, age or location of the child. However, families living in
Cornwall identified that there were limited services available locally. There was not a defined pathway to
receiving support, which families accessed in a variety of ways, including as a result of parental networks
and independent research and via school, medical professionals and charitable organisations. There was
often a domino effect, with families being referred to one support organisation, which then referred them
to a second form of support, and so on. One carer found that support seemed to be automatically provided
once their child had received a diagnosis, but others had needed to proactively find support themselves:
[School] referred us to Team Around the Family, they came out, did an assessment . . . [that] led to
CAMHS . . . they led us to OT . . . then we were passed on . . . to neurodevelopmental.
P15
I wasn’t hanging around waiting for stuff to happen . . . Once you have official diagnosis . . . you’re in the
system and then suddenly everything kind of kicks in.
P6
I went off and did ASD parenting courses, as you do. And probably went into doing quite a lot of self-led
learning and finding support groups for me and for the children . . . Everything we’ve done, we’ve done ourselves.
P23
Support changes since diagnosis

Once children received a diagnosis of autism, this enabled some to receive additional support.
This additional support was most notable in school (e.g. the provision of a statement of special
educational needs or a specialist school placement). However, some families accessed no additional
support following diagnosis:
They just give you a book and . . . there we go, there’s nothing, there’s no therapy available or anything . . .
I thought they’d be like, he’s diagnosed, here are some therapies you can access . . . The only thing the
assessment changed is my peace of mind that it’s not me, it’s not my parenting . . . but that was the
only [benefit] because we haven’t got access to anything extra really . . . it’s pointless, well it’s hard.
P13
Carers’ learning and research

Despite diagnosis not always resulting in additional support for families, carers identified that it empowered
them to look for resources themselves and this had given them a greater understanding of their child
(e.g. in relation to their behaviour and SPDs) and enhanced their ability to give them the support that
they needed:
Some people say why would you want to put a label on it, it’s not about putting a label on her, but we
didn’t know if we were doing things correctly . . . because obviously looking back now, some of the things
that we were doing wasn’t helping, it was making things worse.
P16
Once their child had been diagnosed, many carers found local or online support groups and worked to
increase their own knowledge of autism. However, their ability to do this depended on the networks
and finance available to them. For example, some carers were able to pay for support, whereas others
attended relevant courses through their own work in a similar field and some were able to gain advice
from friends with specialist knowledge.
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Usefulness of support
Generic versus specialist

Specialist support was viewed as being the most useful, whereas carers reported that more generic support
tended not to address their child’s needs. For example, health visitors, who were often the initial source
of support for carers and able to refer to specialist provision, were mainly described by carers as being
dismissive of early concerns about autism. Likewise, carers identified that CAMHS and SLT appeared
unable to deliver support that addressed the needs of their child. In contrast, carers viewed specialist
support as being very useful, particularly parenting courses focused on autism and specialist OT advice,
for example relating to their child’s SPDs:
I had concerns from quite a young age, but the health visitor I felt dismissed my concerns, because I was
seeing lots of red flags and I think . . . they were thinking I was overanalysing.
P20
[CAMHS are] just . . . not equipped to deal with autism . . . she’s got severe, severe anxiety . . . but she’s not
being treated for it because they don’t know how . . . We did a bit of work with one lady, after 4 weeks,
she said ‘Oh I’m unable to help her . . . she just doesn’t understand it’ . . . Meanwhile . . . it’s getting a
whole lot worse and having a massive impact on her life.
P8
I’ve been on loads and loads of [parenting] training . . . the only course I can honestly say that I did enjoy
was the EarlyBird course. Now . . . that was a great help . . . more realistic . . . I really got on with the
parents there, they were in the same situation as me and that’s what I wanted . . . it opened my eyes,
I understand, understood a lot more.
P16
Statutory versus voluntary

Although statutory services (e.g. SLT and CAMHS) tended to be seen as unhelpful, carers reported that
charitable organisations and local disability groups provided the most useful support, even when they
were not specialist autism services. These forms of support helped to fill the identified gaps left by
statutory services and were described as a vital source of help and advice. A key benefit of disability
groups is that they enabled children to take part in activities (e.g. soft play, swimming and the cinema)
that they usually experienced difficulties accessing. Carers noted that these groups provided a less
pressured environment than they had encountered in mainstream activities:
[A local] charity helping disabled children [learn] through play . . . has been a lifeline . . . [The psychologist]
is able to talk to him with the action figures, or with the Lego . . . they can talk about feelings through
that, which is a great asset because . . . empathy was really hard for him. He really struggled.
P9
The National Autistic Society . . . they’re really good. We . . . meet up with other families every now and
again so we go down to . . . an indoor play centre just down the road. Sometimes they rent it out for an
evening . . . we also go to the cinema . . . where they do . . . dimmed lights which is good.
P2
Professionals versus experts by experience

As discussed previously, carers identified that professionals who they had come into contact with often
did not have expertise in autism and, therefore, could not provide support that met the needs of their
child. In some cases, professionals were described as ‘dismissive’ or ‘judgemental’. Conversely, contact
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(online or face to face) with other carers who were in a similar situation was valuable in allowing useful
ideas or strategies to be shared and provided a non-judgemental form of support:
You see it time and time again, it’s schools being unsupportive. Professionals saying, ‘There’s absolutely
nothing wrong’, even though it’s staring them in the face. It’s the parent, you know, the parental blame . . .
your parenting skills.
P29
She was very negative . . . towards [our] parenting . . . And I actually spoke to CAMHS after all this and
said, ‘I don’t want her coming back’, because . . . she made me, well she made us both feel like [we] haven’t
done enough really.
P24
You know that somewhere [on the Facebook group] there’ll be . . . someone saying, yeah I hear what
you’re saying, I’ve been there, I get it, you’re not the only one. And that can be a massive thing, because
obviously being a parent of a child who’s got extra needs, it can feel quite lonely . . . and it’s nice to know
that someone actually understands.
P29
Unmet support needs
Barriers to accessing support

Children’s difficulties being dismissed by professionals was a key barrier to support and resulted
in delayed diagnosis, in a lack of support in school and in referrals for additional help being rejected.
Several carers reported waiting years for their child’s autism diagnosis, despite noticing indicators
of autism early on. In some cases, children (particularly girls) masked their difficulties when outside
the home, which meant that signs of autism were sometimes missed by professionals. Schools were
identified as important in providing support for some families. However, other carers reported that
their child’s sensory needs were not recognised, understood or consistently met in the classroom:
I thought he was autistic for, you know, years now. But [school] weren’t bothered because he’s quite
compliant and no trouble. You know they wouldn’t refer us to the Ed Psych [educational psychologist]
because he’s not, his behaviours aren’t extreme or anything . . . they always refused to do anything really.
P13
He masks at school, he’s a complete masker at school . . . they love him, because he’s as good as gold.
He’s never broken a rule in his life . . . he doesn’t present in the way people think is autistic. And I keep
hearing, oh girls mask, girls mask, [but] boys do it too.
P23
At school he has a very strict rigid sensory timetable . . . six sensory breaks throughout the day . . .
[but] when . . . he’s good for a couple of weeks . . . they slack on [it] . . . and then he’ll start to kick off.
I’m like, ‘Well, are you doing all the sensory stuff?’. ’Oh no, because he’s been really good’.
P25
Gaps in support
A key gap in support was direct therapy for children, particularly OT addressing sensory issues. Some
carers noted that most services they had encountered appeared to focus on support for carers rather
than the child themselves, or that they were diagnostic rather than support services. Carers felt that
it would be useful to have one ongoing point of contact to provide ad hoc advice in relation to issues
arising and to signpost to relevant services. For several families, the main or only continuous support
that they received was from their child’s school. Specifically, carers identified an important unmet need
for mental health provision for children with autism. Some families had been unable to access CAMHS
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because of high referral thresholds (with children not eligible for help even where there were incidences
of serious attempted self-harm), whereas others who did receive services found that provision was limited
or not helpful:
[Support has been] more for us as parents, rather than [him].

P15
What I find now . . . if there’s an issue that crops up, because [three sources of support] have all finished,
[I’ve] only really got the school to deal with now, so if I have an issue, I have got I suppose the Autistic
Society . . . but I find I haven’t got anyone . . . like a professional I can actually ask . . . you know, what
could I do to help this sort of situation?
P2
[We put in] another CAMHS referral because he started self-harming, putting things around his neck and
that, but that got rejected.
P27
There’s no help . . . for these children at all . . . I think it took six referrals to CAMHS . . . she grabbed a
knife, tried to chop her own head off . . . they weren’t really worried about it . . . how bad do things have
to get before an intervention comes?
P8
Limits of support
Carers reported that the support their family received appeared to be time-limited or had stopped
once their child had received a diagnosis. In cases where support had helped their child, children found
the ending of services confusing and carers were frustrated. Limitations in funding or provision had
meant that some families had experienced long waiting lists for support or were unable to afford the
support that they felt their child needed. Carers living in Cornwall identified that local services were
limited or non-existent and, therefore, some families were not provided with specialist support or had
to travel long distances to access it:
I find the support have stopped . . . [the] occupational therapist has gone, it’s like everyone’s gone now.
So we’ve got no support . . . [and] he’s still struggling every day.
P14
He’s had so many like different departments involved in his care . . . Now . . . it’s like right . . . we’ve helped
you . . . we can’t do no more . . . so basically everybody’s signed him off. He’s confused because he now
thinks that everyone’s just dropped him and doesn’t care.
P17
I’ve looked into private SI [SIT], but I can’t afford it, it’s stupidly expensive . . . it’s like £50-odd a session.
I mean, I can’t afford that.
P13
We’ve been waiting about 8 months now for the next step [following diagnosis] and I don’t know when
that’s going to be.
P1
It’s very hard in Cornwall to get onto any parenting course that’s in the evening, and [the courses are
far away, so] I have to either catch the ferry . . . or drive the hour round trip, all around the coast . . .
It’s not practical and it, it puts you off, you think . . . what’s the point, and . . . try and battle on.
P24
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Results: part 2 – perceived impact of sensory integration therapy
Three key themes were identified from interview transcripts in relation to the perceived impact of SIT
and within each key theme there were several emergent subthemes (Table 47). Each theme is discussed
below and is supported by participant quotes. Quotes from carers are labelled with ‘P’, followed by their
participant identification number. Quotes from therapists are labelled with ‘T’, followed by their participant
identification number.
Effect on the child
Became calmer
Most carers identified that their child had become calmer following the intervention. For example,
meltdowns and instances of aggressive behaviour reduced, and concentration in school improved.
Some carers noted that their child remained calmer and more relaxed for several days after each
intervention session. Carers reported that children had learnt coping skills and techniques, which they
had been able to put into practice at home and at school. It was also identified by both carers and
therapists that children became more self-aware and, therefore, they were better able to recognise
their own feelings and sensory needs, enabling children to have more control over their behaviour:
[The sessions were] so good for him that . . . the rest of the day, well even the rest of the week . . . it made
a big difference to him, his behaviour was better, he could concentrate more.
P109
He learnt pretty quickly from the beginning the techniques to calm himself down. And so that was really
beneficial for him, to understand . . . what might make him feel better or what, what might make him
feel worse.
P308
I think she was able to understand and recognise her own needs . . . that was a big . . . learning curve for
her . . . understanding that when my body feels like this, this is what I need to do about it.
T210
That little bit of space in time, before the meltdown happens, she can actually say what she needs to
avoid the meltdown . . . [She] is now aware of her body and what she needs to keep things under control.
P514
TABLE 47 Themes and subthemes: perceived impact of SIT
Main theme Subtheme
Effect on child Became calmer
Developed skills
Increased tolerance of everyday tasks
Increased confidence and independence
Effect on school and family life Changed everyday life
Learning for carers
Strategies for home and school
Limitations Changes not always sustained
Not always the best approach
Outcomes dependent on parental engagement
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Developed skills
While receiving the intervention, children’s fine and gross motor skills improved. For example, children
developed their ability to complete everyday tasks, such as getting washed and dressed, going to the
toilet unaided and using a knife and fork. Improved physical skills enabled some children to access
new activities, such as playing football, riding a bicycle and utilising a greater range of playground
equipment, meaning that some were more able to join in with their peers. Children’s awareness of,
and confidence in, their own body also improved, including through developments in co-ordination,
balance, spatial awareness and motor planning, and this increased physical confidence and meant that
some were more willing to attempt new activities:
One of the things that stood out for me . . . it might not seem like a big thing but for him it was . . .
we went to a park and he just sat on the swing upright instead of prone, and he was able to do that with
his friend, whereas before he would have just avoided it, because he wouldn’t have wanted to show his
friend that he didn’t sit on the swing.
P703
[One boy] loved football . . . and he was able to participate in playground football, having done this
intervention . . . He just wasn’t able to do it, for various reasons, before . . . in the playtimes he would go
to like a nurture class instead of going [outside].
T211
I feel that his confidence in his own body has increased. Before we would go to the park or something
and he wouldn’t really explore the apparatus and stuff, but now he can, I can see that he’s got confidence
to try things . . . I think he’s got more body awareness, and I think it’s just really increased his general
confidence in himself and his ability of what his body can do.
P703
For one child her self-esteem had really increased and [her] willingness to try new things . . . she went on a
school trip . . . [to] an activity centre . . . and her mum [said] . . . before she wouldn’t have attempted to go
on any of the equipment. But, but this time she tried absolutely everything . . . it’s just giving her that kind
of confidence about what she can do with her body.
T213
Increased tolerance of everyday tasks

Following the intervention, carers noticed that their child’s ability to tolerate everyday tasks, such as
washing, nail cutting and hair brushing, had improved and this had meant fewer meltdowns and enabled
some children to access activities that they had previously been unable to participate in (e.g. swimming).
Notably, although one carer reported that their child’s tolerance of toothbrushing had increased, several
identified that this was still an issue:
If you’ve got a child who is unable to tolerate water, and then . . . can’t go swimming, can’t access a splash
park, [or] can’t tolerate wearing a helmet . . . [and then] can’t do those lovely early childhood occupations,
like ride a scooter or a bike, then they’re missing out, aren’t they . . . The first child that I worked with . . .
[learnt] to tolerate those things . . . [and] he was able to ride a scooter, which he’d never done . . .
before because he wouldn’t wear a helmet.
T210
The toothbrushing was a complete failure. He still won’t do that at all.

P506
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Increased confidence and independence

It was commonly identified by both carers and therapists that children’s confidence increased during
the intervention. For example, carers reported that children were more willing to try new activities
or foods and could cope more effectively with new situations and changes. Some children had begun
to socialise more and, as their confidence increased and communication skills developed, they became
more able to express their needs to others, which had enabled them to become more independent.
For example, one carer reported that she was now more confident that her child – who had previously
been looked after by family members only – would cope in holiday clubs:
Even [the therapist] saw a huge difference in him in the time that she’s been working with him, from a
boy who didn’t feel that he had the confidence to do anything to all of a sudden just waltzing in, going off
and doing his own thing.
P109
It’s really improved his confidence . . . he’s happy to go out in the community, he’s happy to try new things
. . . he’s been less anxious . . . His parents have noticed a massive difference in his behaviour at home and
he’s engaging in things that he never engaged in before, he’s doing things he’s never done before.
T207
Effect on family and school life
Changed everyday life

Some carers described the intervention as ‘life-changing’ for their child and the whole family. In some
cases, this was because it was the first helpful form of support that they had been able to access.
As children learnt new skills, had increased in independence and were better able to tolerate everyday
tasks, their meltdowns reduced and daily routines became less problematic, resulting in less stress and
improved quality of life for carers. Carers identified that children had improved their ability to cope
with changes and new situations, meaning that they were more confident in going on family days out.
Notably, several carers stated that now their child had received the intervention they could envisage
them becoming independent in the future. For some children, teachers had also commented that their
confidence, skills and general behaviour had improved. Carers too reported that children had increased
in their ability to cope in the classroom:
Before the [intervention] I didn’t know what to do or where to go because he was struggling so much,
but it seems to have made him settle down a lot . . . It’s literally changed his life but changed our
life as well. You know, it’s only a short space of time but it has made so much difference to us . . .
I am just completely in awe of the differences in him.
P109
Before the [intervention] I used to question whether he would ever be independent enough to live on his
own. Whereas now I am starting to feel that maybe he would be OK.
P109
I’ve seen an improvement in [her] . . . and it’s not only me, it’s been school as well, they’ve noticed her
behaviour has improved . . . she’s overall calmer and she can cope with situations better.
P514
Learning for carers

Carers reported that the intervention enabled them to understand their child better. For example,
carers had increased their understanding of their child’s sensory needs, enabling them to make changes
at home and at school. Understanding the reasons behind their child’s behaviour made some carers
more confident and improved parent–child relationships, as they realised that some behaviours they
120

had previously perceived as negative were because of their child’s sensory difficulties. As a result
of this improved understanding, some carers became empowered to advocate for their child by, for
example, ensuring that they were appropriately supported in school:
It’s helped us understand him a little bit more . . . I hadn’t appreciated . . . that he doesn’t like tilting his
head backwards . . . and so we’re sort of working on ways . . . [to] try and help him . . . So that’s sort of
been quite interesting, realising, learning about that for him.
P609
I think it was a huge step for mum in a way, whereas [before] she felt so helpless . . . what’s going on with
my daughter and how can I help her, to the point of OK I can do this, that and the other . . . Definitely
empowered her.
T206
We couldn’t really understand why she did certain things . . . what [the intervention] did was identify what
she was doing and why . . . Just from learning why she does all the things she does . . . you just realise
actually that she’s not being awkward, she’s not being selfish or stroppy, she has to do it that way to
function and I think that’s the biggest thing we got from it, is maybe understanding her a little more.
P219
Strategies for home and school

Therapists had given carers strategies and ideas to try at home, which they mostly found effective.
For example, advice to encourage children to be more physically active had helped to regulate their
behaviour. Therapists had taught relaxation techniques to some older children, which had been used
successfully at home and at school. Therapists had also provided ideas of sensory activities that carers
could implement at home to address the needs of individual children, such as messy play or obstacle
courses. Carers reported that suggestions of equipment to purchase were particularly helpful. For example,
items such as a weighted blanket, which had helped their child to relax, and larger equipment such
as swings or gym balls, which children could use to self-regulate. Some children had used suggested
equipment, such as wobble cushions, in school, which had helped to improve their concentration.
Therapists had also suggested strategies to help carers handle specific situations, such as giving children
step-by-step instructions or providing sensory stimulation to children before carrying out certain tasks
(e.g. hair brushing or nail cutting):
[The therapist] suggested an air cushion for him, for him to sit on in school and apparently it’s really good
for concentration and stuff. So she lent us one to try and it worked really well.
P109
We noticed car doors are a big thing, he won’t open the car door if it’s wet, but . . . [now] we tend
to give him a lot of pressure on his hands and things before he goes out, before he leaves the house.
And then he’ll open the door, without even thinking about it. So it’s just little things like that.
P308
Limitations
Changes not always sustained

For some children, carers reported that changes in behaviour and tolerance of everyday tasks were
sustained following the intervention. Some children had continued to make progress when carers
carried out activities suggested by the therapist and as a result of greater support provision at school.
However, some carers identified that their child’s behaviour had deteriorated after the intervention
sessions finished, for example with increased meltdowns. Although some carers felt that their child
121
would need therapy continuously, others suggested that lengthening the intervention could help to
bring about more lasting changes:
He will still wear his helmet [and go in] his car seat . . . it’s really lasted, it’s really desensitised him to
certain things, you know. I dread to think what he’d be like if we turn that back, oh God.
P304
I think it needs to be continuous input, [otherwise] it doesn’t really work . . . I don’t think it, it works and
then you’re cured as such. You need to continue to do it . . . But I think it’s helped him, because we’ve got
ideas at home that he can use.
P506
Not always the best approach

The therapist interviews did not include any questions relating to the perceived appropriateness of
the intervention for children participating in the trial. However, a minority of therapists strongly
felt that using pure SIT was restrictive. These therapists suggested that a flexible approach – whereby
a range of techniques could be applied to tackle different therapy goals – would be more helpful,
as SIT was not always the most efficient or appropriate way of achieving set outcomes. In particular,
it was difficult to tackle issues such as problems with toothbrushing in the play environment, rather
than in the context of the child’s home. Therapists also reported that using SIT to address functional
skills necessitated a lot of input, as they were required to hypothesise how improvements in
sensory integration could affect children’s skill performance, rather than working on improving the
skills themselves:
Out of the three children [I saw] . . . if I hadn’t been part of the research, probably only one of those
children I would have looked at using [SIT] for them. The other two children I would have used very
different mechanisms to achieve the goals . . . in a much shorter . . . time . . . There was one about cutlery
and I think if we [had] just looked at different adaptive cutlery, I think that they would have achieved
that goal.
T205
You had to write your hypothesis . . . so for instance, when the child set bottom-wiping as a goal . . . my
hypothesis was that because she had tactile issues and issues understanding where her body was in space . . .
as she became more aware of her environment, was able to process tactile information more readily . . . she
would have more success with bottom-wiping . . . It did work . . . But it’s an awful lot of input to give, to get
to that.
T212
Outcomes dependent on carer engagement

Therapists identified that children’s progress was facilitated when carers were fully engaged with the
intervention. Some carers were fully committed in terms of attendance, were interested in ideas
suggested by the therapist and were keen to learn. Carers tried to suggest activities and strategies at
home, and some purchased sensory equipment. However, where carers were less committed, their child’s
progress was limited. For example, some carers did not ensure that their child attended intervention
sessions regularly, did not implement suggestions at home or appeared not to be motivated to learn more
about their child’s difficulties. Therapists noted that for therapy goals to be reached and changes to be
sustained, it was important that activities from the sessions were continued at home.
Some families faced barriers to implementing the suggested activities at home. For example, some
families did not have the time to engage in one-to-one activities with their child, as they had other
children who also had additional needs, and some carers themselves had autism or sensory issues, which
affected their ability to understand SIT and to engage in sensory play with their child. For instance,
122

some carers did not realise the importance of play, did not understand how to play or had an aversion
to messy play:
The first child that I worked with . . . alongside the [intervention] the parents have made sure they’ve been
doing lots of [physical activity] with him outside, outside the sessions as well, and I’ve seen an absolutely
massive difference in him, he’s like a different child.
T207
Some have been very . . . on board and open to any suggestions . . . others I think [have] not fully understood
the commitment and found it quite hard and then that makes our life hard, because then we’re seeing
changes but we’re not able to progress them . . . because their parents are not taking them on.
T208
She’d missed out on a lot of sensory experiences . . . And, you know her mum and dad did recognise that.
So that was really interesting. And it was during some of the sessions where we used a lot of messy play
and worked on her tactile system, you know you could see the parents were horrified . . . and they were
able to recognise that they had some tactile issues themselves.
T201
It was a real challenge with the parents with autism to help them understand [the intervention] and I’m
really not sure that they did.
T212
Summary
Support provision for families varied widely, and there was no clear pathway of support for children
and families following autism diagnosis. In some cases, access to support was dependent on carers’
resources. Non-specialist services tended not to meet children’s needs. However, specialist provision
was generally not accessed until the later years of primary school. Key barriers to support included
professionals being dismissive of children’s needs, limited local service provision and lengthy waiting
lists. Unmet support needs included a need for direct therapy for children, specialist mental health
provision and ongoing information and advice for carers.
Following the SIT intervention, carers and therapists reported that children became calmer, developed
their physical skills, were better able to tolerate everyday tasks and increased in confidence and
independence, and this resulted in changes in day-to-day family and school life, making daily routines
and changes being easier to manage. Carers developed a better understanding of their child and were
able to implement strategies and activities suggested by the therapist. However, for some children,
changes in behaviour were not sustained following the intervention. A minority of therapists felt
that using SIT was not the right approach for all children who they provided therapy to. For example,
functional skills, such as toothbrushing, may be better addressed in the context of the child’s home.
It was also noted by therapists that therapy outcomes were dependent on the level of parental engagement
in the intervention.
123
Chapter 10 Discussion
Overview
In this chapter, a summary of the results is presented, with interpretation of findings discussed in the
context of previous research and the original commissioning brief for this study, which noted that,
although SIT is sometimes delivered in the NHS, there is limited evidence to support effectiveness
(as also stated in the NICE clinical guideline for children with autism17).
Summary and interpretation of findings
Recruitment and retention

The overall recruitment target (revised as per planned sensitivity analysis of sample size assumptions
following the internal pilot) was met and 77.5% of randomised participants provided outcome data
at the primary outcome time point. Loss to follow-up was slightly higher than the estimated 20%.
However, given that all other assumptions relating to the sample size calculation were met, power to
detect the target standardised effect size of 0.5 for the primary analysis remained at 90%. Longer-term
(12-month) retention was lower at just under 70% (69.6%), although no between-arm difference was
evident and this may reflect the complex life circumstances of the population (i.e. carers of young
children with neurodisability who may also be working and caring for other children/family members).
Baseline characteristics and reach

Participants were well balanced across arms in terms of baseline characteristics. Most (79%) participants
were male and white British (88%), reflecting those likely to have received an autism diagnosis. Autism
is underdiagnosed in girls111 and ethnic minority boys112 for a variety of complex reasons, including
stereotypical beliefs about presenting symptoms and perceived stigma. Most (71.7%) participants were
recruited from South Wales and had a mean age of approximately 7 years and 10 months. Recruited
participants showed significant sensory dysfunction. Eligibility criteria required at least probable
dysfunction on two or more sensory dimensions of the SPM and the total score, or definite dysfunction
on one dimension and total score. All potential participants screened met criteria, in line with available
SPD prevalence estimates in autism,9–11 and 77.5% of participants had definite sensory dysfunction.
A significant proportion of participants (25%) also had a diagnosis of ADHD.
Usual care and contamination

As detailed in Chapter 2, and confirmed during the internal pilot phase (see Chapter 4) and qualitative
interviews with carers (see Chapter 9), usual care for young children with autism and SPDs is highly
variable and, in many cases, comprises no formal OT intervention. Sensory-based difficulties are commonly
reported and there is a clearly expressed demand from carers for services that specifically address sensory
difficulties. Current NHS provision is generally focused on delivery of sensory strategies and advice
(e.g. generic written information, bespoke leaflet, parent/carer groups and one-to-one consultations),
although evidence to support the use of sensory strategies is limited (see Chapter 1). Some direct
therapy may be offered using a sensory integration approach, but this does not generally meet fidelity
criteria for SIT, in terms of both content and dose/frequency of contact. Where carers do access SIT,
this is generally from private practitioners and, therefore, is inaccessible to most families. In terms of
contamination, one trial participant allocated to the control arm received SIT, but sensitivity analysis
suggests that this is unlikely to have influenced interpretation of results and no other evidence of sustained
contact with OT services was reported. We found no evidence to suggest that families allocated to SIT
were in receipt of significant OT intervention.
125
DISCUSSION
Fidelity and intervention receipt

Overall, SIT was delivered with good fidelity. All clinics were rated as achieving structural fidelity,
meaning that the level of therapist training, documentation and the physical environment (including
equipment) met the required standard for SIT. Ten out of 12 therapists met criteria for process fidelity
consistently across sessions (i.e. ensured safety and established therapeutic alliance, and provided the
appropriate level of challenge and sensory opportunity). It was not possible, however, to rate fidelity
for all therapists (as no useable recordings were available for 4 out of 16 therapists). However, therapists
did receive mentoring throughout intervention delivery, with a focus on aspects central to fidelity.
Rater agreement was generally good, although lower average scores for two therapists may reflect
poor inter-rater agreement, particularly where more than two ratings per session were available.
The pattern of intervention receipt was variable, although 78.3% of participants allocated to the
intervention arm had received 13 out of 20 SIT sessions during the intensive delivery phase (defined
as the target dose, of a possible 26 sessions overall). However, many participants received more than
13 sessions in total, with a median of 20 sessions received.
Acceptability
In terms of acceptability of trial procedures, most carers were very positive about their experience
of taking part in the trial. A significant proportion of carers allocated to receive the intervention,
however, reported some degree of difficulty or inconvenience in travelling to appointments, particularly
given the frequency of contact. Outcome measures were also felt to be acceptable. Diary completion
(detailing contact with other services) was poor, although the introduction of an automated text
reminder service did increase response rates. Therapists reported a degree of difficulty with some trial
processes and technology and were generally unfamiliar with the level of documentation required in
clinical trials. In addition, most therapists reported difficulty in completing assessments and paperwork
within the time estimated as per excess treatment costs.
Carers of children randomised to receive SIT reported high levels of satisfaction with the intervention,
and many carers felt that it had been of significant benefit to their child and often to the wider family,
in terms of facilitating activities it had not previously been possible to engage in. Carers and therapists
tended to report that children were calmer, more independent and better able to tolerate everyday
tasks following receipt of SIT. Carers also reported increased understanding of their child and felt able
to implement strategies suggested by the therapist. However, perceived positive changes in behaviour
were not necessarily sustained in all cases once therapy was complete.
Therapists’ experience of delivering SIT was also generally very positive. Many NHS therapists reported
being unused to offering treatment so intensively and, although some therapists had found the
experience challenging, felt that it had been professionally rewarding and was an approach that could
offer benefit to some children. However, most therapists viewed SIT as part of a range of treatment
options, the appropriate choice of which would depend on the child and their needs.
Behavioural outcomes
There was no evidence of a statistically significant difference between trial arms for the primary
outcome, that is irritability/agitation, which is a measure of challenging behaviour (as assessed by the
ABC-I67 at either 6 or 12 months). Parent-assessed ABC-I ratings at 6 months were, on average, higher
than teacher ratings (where available). It is likely, however, that this indicates a true difference in
behaviour and functioning in different settings, rather than a reporting bias on the part of either type
of participant. Exploratory subgroup analyses suggest a differential effect of SIT on ABC-I at 6 months
by sex of child, indicating that SIT was more effective for male participants. Subgroup analyses also
indicate that the intervention was more effective in participants with a comorbid ADHD diagnosis. It is
important to note, however, that even where statistically significant subgroup effects suggest clinically
relevant change, that these analyses are hypothesis-generating only and may reflect multiple testing.
We found no evidence of a differential effect of SIT on 6-month ABC-I scores by level of SPD, general
126

comorbidity, ID or other neurodevelopmental or genetic condition. Likewise, no effect of SIT was

observed for other ABC subscales (i.e. lethargy/social withdrawal, stereotypic behaviour, hyperactivity
or inappropriate speech) at each time point.
Additional sensitivity analyses suggest that scores on the ABC-I at 6 months were generally better
in those who initiated and received SIT. However, adjusting for the initiation of SIT did not alter the
conclusions drawn based on the primary analysis (i.e. there was no evidence of a difference between
the intervention arm and the control arm). Sensitivity analyses did not indicate any pandemic-related
effects on outcome. No between-arm differences were observed at 6 or 12 months for adaptive behaviour,
socialisation or daily living skills (using VABS domains). As detailed in Chapter 6, an error in administration
of the VABS measure resulted in the introduction of an artificial ‘ceiling effect’ for these subdomains,
meaning that it was less sensitive to change. A statistically significant between-arm difference was
observed for the communication domain (indicating a negative intervention effect), although this is felt
likely to reflect a combination of multiple testing, ceiling effects and an outlier in the control arm, rather
than a clinically meaningful difference. Further sensitivity analyses would be unlikely to add to the
interpretation of results, given that no other marginal effects were observed and the pattern of results
was similar to that observed for all other outcome measures.
Parenting stress, quality of life and health utility

No between-arm differences were evident for parenting stress, quality of life or health utility.
However, subgroup analyses suggest a differential effect of SIT on carer stress (using the APSI)
at 6 months by region. A similar effect was observed for the presence of other neurodevelopmental
or genetic conditions on carer stress, although this may indicate type I error.
Functional outcomes: occupational performance

There is strong evidence to suggest that carer-rated goal performance and satisfaction increased
significantly with SIT exposure. This finding is in line with two previous trials of SIT,33,34 which reported
significant effects for GAS. However, as detailed in Chapter 1, both trials were underpowered and did not
assess maintenance of skills (i.e. did not include longer-term follow-up), and descriptions of comparators/
usual care were limited.33,34 It is possible that, given the individualised nature of SIT as an intervention,
individualised goal-based outcome measures would be more sensitive to change. However, it is uncertain
whether or not improvements in performance can be maintained in the longer term. Furthermore, data
were available (COPM) for a subset of intervention participants only. It was not possible to collect these
data from participants in the control arm, as participants in the control arm were not routinely seen by
occupational therapists and not all intervention therapists recorded goals consistently.
Health economic analysis

Delivery of SIT incurred significant additional costs. When intervention costs were not included in
total NHS/PSS costs, NHS/PSS costs of care for usual care-only participants were significantly higher
than for SIT participants. The mean difference in ABC-I scores between arms did not achieve statistical
significance at 6 or 12 months, suggesting no additional clinical benefit of SIT. Economic evidence
suggests that SIT has a low probability of being a cost-effective option compared with usual care.
Summary
In summary, the SenITA trial was a robustly conducted evaluation of the clinical effectiveness and
cost-effectiveness of SIT for behavioural, functional and quality-of-life outcomes. Targets for recruitment,
retention and other key parameters used to estimate sample size were met, maintaining 90% power at
the primary analysis time point. Usual care was significantly different from the intervention offered as
part of the trial and was delivered with good fidelity and adherence. In addition, there is no evidence of
significant contamination in the control arm or of those allocated to SIT receiving meaningful intervention
via other routes. No adverse effects were reported. The population recruited are likely to be representative
of young children with a diagnosis of autism and presenting to services, although this is distinct from
being truly representative of the target population, given the well-documented underdiagnosis of autism
in girls and minority ethnic children.
127
DISCUSSION
Trial procedures and outcome measures were acceptable to carers, and therapists generally found
involvement in the trial to be a positive experience. However, many therapists reported issues with
management of trial documentation and technology and many felt that the time allowed for assessment
and recording clinical notes was insufficient. Carers in the intervention arm reported high levels of
satisfaction and benefit of SIT, although no statistically significant quantitative change in carer stress was
observed. Both carers and therapists tended to report improvements in well-being and daily functioning,
although there is no evidence to suggest that these effects were maintained following the end of therapy.
Therapists’ experience of delivering SIT was also generally positive, and most felt it to be an approach that
could offer benefit to some children, depending on their needs.
There were, however, no statistically significant effects of SIT on any behavioural, functional, quality-
of-life or well-being outcomes at either 6 or 12 months (with the exception of the VABS communication
subdomain, as discussed above). Sensitivity analyses do suggest that scores on the ABC-I at 6 months
were generally better in participants who received SIT and that intervention may work better for boys
and participants with a comorbid ADHD diagnosis, although these were exploratory analyses and should
not be overinterpreted. Carer-rated goal performance and satisfaction did increase significantly with SIT
exposure. However, there is no evidence to suggest that improvements were maintained, and data were
available for only a subset of intervention arm participants. Health economic evaluation also indicates that
SIT is unlikely to represent a cost-effective treatment option when compared with usual care.
Strengths and limitations
Strengths
The key strength of the SenITA trial is that it was adequately powered to answer the key question in
the original commissioning bid of ‘What is the effectiveness and cost-effectiveness of SIT for children
with autism?’. Important outcomes, as detailed in the commissioning brief, were challenging behaviours,
socialisation, engagement with activities and sensory sensitivities. Other potential outcomes listed
included adherence to the therapy manual, process indicators, health-related quality of life, carer burden,
adverse effects and cost-effectiveness. The trial was sufficiently powered to determine effectiveness of
manualised SIT on the primary outcome, that is, a measure of challenging behaviour. The intervention
was also delivered with good fidelity and adherence and was acceptable to both families and therapists;
no adverse effects were reported. Inclusion of longer-term (12-month) outcome assessment is also a
strength, as previous studies33,34 of SIT have assessed outcomes post intervention only (or at an equivalent
time point in the comparator arm).
This trial has also made a significant contribution to knowledge around what is generally delivered as
usual care to children with autism and SPDs. In addition, the trial has highlighted the gap between
services generally available to families (e.g. advice, strategies to improve functional/daily living skills)
and services that carers would most value (e.g. intervention to support behavioural problems).
Limitations
Although SIT was generally delivered with good fidelity and all therapists met the required minimum
threshold for training and experience, most therapists in Wales were employed by the NHS and had
little recent experience of delivering full-fidelity SIT within their NHS roles. In England, trial therapists
were working privately, as we were unable to recruit sufficiently trained and experienced therapists in
England for a variety of reasons, including a reluctance of therapists to offer therapy via participation
in the trial that was not otherwise available and, therefore, setting a level of expectation among families
that could not be sustained. Subsequently, therapists at English sites were more used to delivering SIT
with this population and did not have to juggle the competing demands of local service targets. Therapists
also reported that the time allowed for assessment and clinical reasoning was insufficient, particularly
at initiation of therapy, meaning that the total costs of intervention would probably be higher than
indicated in practice.
128

For a variety of pragmatic reasons, including therapist availability and workload, some participants
allocated to receive SIT did not start intervention within the intended time frame and had, therefore,
received a potentially lower dose of SIT by the primary outcome assessment time point. Sensitivity
analyses, however, indicate that this is highly unlikely to have significantly affected any key findings.
A further limitation is the artificial ceiling effect observed for domains of the VABS. Interpretation of
the positive effect on carer-reported goal performance is also limited by the fact that not all intervention
therapists reported this consistently and that it was not possible to measure this in the control arm, as
participants were not generally in contact with services.
Conclusions and implications
The results of the SenITA trial indicate that SIT shows no clinical benefit across a range of outcomes
(i.e. behavioural, functional, social, quality of life and well-being) over and above standard care for
young children with autism and at least moderate SPDs. In addition, the results also indicate that SIT
is not a cost-effective treatment option in this population. Several subgroup effects were observed,
although these should be considered hypothesis-generating only and would require further exploration.
Subgroup effects are, however, consistent with qualitative data, indicating that therapists felt that SIT
could be of benefit to some, but not all, children with autism and sensory difficulties. It is likely that
SIT is effective for individualised (carer-reported) performance goals; however, it is not known if this
effect is observed over and above standard care and if improvements can be maintained following the
end of treatment.
129
Acknowledgements
W e would like to thank all of the children and parents/carers who took part in the SenITA trial.
Many thanks go to all SenITA trial therapists, mentors and parents/carers who contributed to
the study through the advisory group, and to all independent members of the Trial Steering Committee
and Data Monitoring Committee. Thanks to Jacqui Thornton and Dunla Gallagher for their input to
qualitative analysis of usual-care data (see Chapter 2) and to Kath Smith for input to the intervention
handbook and therapist training. Thanks also to Jade Williams at the Centre for Trials Research for
providing administrative support.
Contributions of authors
Elizabeth Randell (https://orcid.org/0000-0002-1606-3175) managed the trial, contributed to report

writing and prepared the report for publication.
Melissa Wright (https://orcid.org/0000-0002-1011-4795) carried out the statistical analysis and wrote
up the results for publication.
Sarah Milosevic (https://orcid.org/0000-0003-1973-8286) carried out interviews with carers and

therapists, led the qualitative analysis and contributed to report writing.
David Gillespie (https://orcid.org/0000-0002-6934-2928) managed the statistical analysis and

contributed to report writing.
Lucy Brookes-Howell (https://orcid.org/0000-0002-8263-7130) led the qualitative components of the

trial and contributed to qualitative analysis and report writing.
Monica Busse-Morris (https://orcid.org/0000-0002-5331-5909) provided expertise in evaluation of

therapeutic interventions and contributed to report writing.
Richard Hastings (https://orcid.org/0000-0002-0495-8270) provided expertise in research in children

with autism and contributed to report writing.
Wakunyambo Maboshe (https://orcid.org/0000-0002-9195-0030) carried out data management.
Rhys Williams-Thomas (https://orcid.org/0000-0002-1779-3460) carried out trial and data management

activities and collected quantitative data.
Laura Mills carried out quantitative data collection.
Renee Romeo (https://orcid.org/0000-0003-3871-9697) managed the health economics analysis and

contributed to report writing.
Nahel Yaziji (https://orcid.org/0000-0002-2273-7957) carried out the health economics analysis.
Anne Marie McKigney provided clinical and research expertise in relation to children with autism.
Alka Ahuja (https://orcid.org/0000-0003-2658-2021) provided clinical and research expertise in

relation to children with autism.
Gemma Warren led the patient and public involvement component of the trial.
131
ACKNOWLEDGEMENTS
Eleni Glarou (https://orcid.org/0000-0001-5666-2458) contributed to interpretation of therapeutic

mechanisms and qualitative data.
Sue Delport (https://orcid.org/0000-0001-8065-5493) co-led the study, provided clinical expertise in

relation to OT and the trial intervention, and contributed to report writing.
Rachel McNamara (https://orcid.org/0000-0002-7280-1611) co-led the study and contributed to

report writing and preparation of the final report.
Data-sharing statement
All available data, study handbooks and the full trial protocol can be obtained by contacting the
corresponding author.
132

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Health Technology Assessment

Sensory integration therapy for children

Elizabeth Randell ,1* Melissa Wright ,1

*Lead and corresponding author

Published June 2022

Randell E, Wright M, Milosevic S, Gillespie D, Brookes-Howell L, Busse-Morris M, et al. Sensory

ISSN 2046-4924 (Online)

Impact factor: 4.014

Editorial contact: journals.library@nihr.ac.uk

Criteria for inclusion in the Health Technology Assessment journal

NIHR Journals Library Editors

Dr Tessa Crilly Director, Crystal Blue Consulting Ltd, UK

Ms Tara Lamont Senior Adviser, Wessex Institute, University of Southampton, UK

Dr Catriona McDaid Reader in Trials, Department of Health Sciences, University of York, UK

Professor Geoffrey Meads Emeritus Professor of Wellbeing Research, University of Winchester, UK

Please visit the website for a list of editors: www.journalslibrary.nihr.ac.uk/about/editors

Editorial contact: journals.library@nihr.ac.uk

NIHR Journals Library www.journalslibrary.nihr.ac.uk

Sensory integration therapy for children with autism and

Elizabeth Randell ,1* Melissa Wright ,1 Sarah Milosevic ,1

*Lead and corresponding author RandellE@cardiff.ac.uk

NIHR Journals Library www.journalslibrary.nihr.ac.uk

List of figures xvii

List of abbreviations xix

Plain English summary xxi

Scientific summary xxiii

Chapter 4 Internal pilot evaluation 37

NIHR Journals Library www.journalslibrary.nihr.ac.uk

Chapter 6 Quantitative results 53

Chapter 7 Health economics 73

Chapter 8 Process evaluation: recruitment, retention, fidelity and safety 93

NIHR Journals Library www.journalslibrary.nihr.ac.uk

Chapter 10 Discussion 125

Strengths and limitations 128

NIHR Journals Library www.journalslibrary.nihr.ac.uk

TABLE 2 Contact with services (n = 159) 9

TABLE 3 Interventions received by families (n = 159) 11

TABLE 4 Therapist advice given to carers 16

TABLE 5 Interventions for children/families 16

TABLE 6 Schedule of enrolment, interventions and assessments 28

TABLE 7 Contents of the research assistant data collection manual 29

TABLE 8 Contents of the SenITA intervention therapist data collection manual 31

TABLE 9 Criteria for progression from internal pilot to full trial 39

TABLE 10 Respondents by geographical region (pilot evaluation phase) 40

TABLE 11 Recruitment figures against progression criteria 41

TABLE 12 Retention figures against progression criteria 42

TABLE 13 Summary of internal pilot findings 43

TABLE 15 Levels of adaptive responses 51

TABLE 16 Baseline characteristics 54

TABLE 17 Summary of baseline ADOS scores by trial arm 56

TABLE 18 Descriptive statistics of SIT implementation for six participants 59

TABLE 19 Baseline scores by arm 60

TABLE 20 Outcome scores at 6 and 12 months 61

TABLE 23 Comparison of COPM scores between session 1 and session 24 67

TABLE 24 Subgroup analyses for ABC-I at 6 months 68

TABLE 25 Subgroup analyses for Carer Stress at 6-months 69

TABLE 28 Primary outcome analysis under different scenarios 72

TABLE 29 Unit cost (2020/21) of SIT sessions 75