Piacentini 2011
Piacentini 2011
Piacentini 2011
P
ediatric obsessive-compulsive disorder (OCD) domized controlled trials for pediatric OCD
is a common, functionally impairing, and yielded effect sizes of 1.45 (95% CI ⫽ 0.68-2.22)
distressing condition that can be debilitat- for CBT and 0.48 for pharmacotherapy (95% CI ⫽
ing in its severe forms.1-3 Untreated, the disorder 0.36-0.61)8; however, weaknesses in comparison
is usually chronic, disrupts normal development, conditions and other features complicate interpre-
and places youth at risk for multiple concurrent tation of the extant data. Based on existing compar-
and long-term psychiatric comorbidities.3 Thus, ative efficacy and safety data, CBT has emerged as
the development and testing of effective inter- the most often recommended first-line treatment
ventions for childhood OCD remains a clear for OCD in youth.4,8,9
public health priority. Nonetheless, efforts to optimize CBT and to
To date, evidence has emerged to support the establish its effectiveness for pediatric OCD lag
efficacy of both exposure-based cognitive-behavioral behind similar efforts for other disorders,9 and,
therapy (CBT) and pharmacological intervention surprisingly, no treatments for this disorder cur-
with the serotonin reuptake inhibitors (SRIs) for rently meet criteria as a well-established evidence-
this disorder.4-9 A recent meta-analysis of ran- based psychosocial treatment.10 Although the
CBT literature for pediatric OCD may seem may undermine response.15-17 In particular, ac-
crowded, a recent review4 identified only two commodation (i.e., participation in rituals and/or
methodologically rigorous published random- modification of routines) is highly common
ized controlled trials (e.g., Type 1 studies),11 among families of OCD youth15,17 and may me-
comprising a total of 81 subjects treated with CBT diate the link between symptom severity and
alone.7,12 Although several less rigorously de- functional impairment.17 Family accommodation
signed CBT trials (e.g., Type 2 studies, defined as is thought to be a barrier to treatment inasmuch
including a comparison group but with other as it reinforces avoidance behaviors and under-
methodological limitations)11 have been pub- mines exposure-based exercises.15
lished,4 methodological concerns, including Unfortunately, research evaluating systematic
lack of randomized assignment, small sample efforts to address family accommodation and
size, or comparison of different intensity levels related factors is complicated by the heteroge-
of the same treatment, partially limit the im- neous nature of the literature with regard to the
pact of these trials for determining the efficacy intensity and structure of family involvement,
of exposure-based therapy for childhood OCD. especially because some level of parental in-
Importantly, no adequately powered, random- volvement in treatment is typically specified for
ized controlled CBT trial for pediatric OCD has OCD youth. Barrett et al.4 attempted to clarify
used a matched active comparison condition confusion over what constitutes a “family treat-
designed to control for the nonspecific effects of ment” by defining individual child ⫹ family
exposure-based CBT. Such a design is critical for interventions (FCBT) as those treatments that
determining whether the mechanisms underly- specify structured weekly intervention sessions
ing an observed treatment effect go beyond the focused on changing family dynamics as op-
nonspecific consequences of attention or the ex- posed to primarily individual child treatments
pectation of change.10 Moreover, because they that include family members in a less structured
are designed to isolate putative “active” treat- or less frequent manner, often as a brief check-in
ment elements, psychotherapy trials that use at the end of individual sessions. Using this
active comparison groups both increase confi- definition, only two studies, one Type 1 (N ⫽
dence in the specific explanatory model on which 77)12 and one Type 2 (N ⫽ 40),18 have critically
the treatment is based and suggest that particular evaluated FCBT, and only one18 found post-
kinds of training and experience may be neces- treatment changes in family dynamics, with fam-
sary to produce the desired treatment effect.10 ilies receiving intensive FCBT demonstrating
Thus, the design of the current study, which greater reduction in family accommodation com-
contrasts individual exposure– based CBT for the pared with those receiving weekly treatment.
child plus a concurrent family intervention Moreover, in a partially overlapping sample of
(FCBT) with a matched active psychosocial com- children receiving FCBT through one of two
parison treatment consisting of psychoeducation separate open-label studies (N ⫽ 49), decreases in
about OCD plus relaxation training (PRT), rep- family accommodation over the course of treat-
resents an important step for establishing the ment predicted reduced symptom severity and
efficacy of FCBT for child OCD, especially in OCD-related impairment post-treatment.19 Al-
light of past non-OCD pediatric anxiety trials though these findings require replication under
that failed to differentiate CBT from compari- controlled conditions, they suggest that efforts to
son therapies.13,14 target relevant family dynamics may lead to
The need for expanded research in this area is improved treatment outcomes.
driven by several additional concerns. Perhaps Finally, only one prior published controlled
most important is the realization of substantial FCBT trial for childhood OCD has employed a
room for improvement in treatment outcomes for credible psychosocial comparison condition.20
pediatric OCD, particularly in light of findings Although that study included a relaxation train-
that more than one-half of study participants fail ing comparison condition similar to that used
to achieve symptom remission in response to here, that study was primarily a feasibility trial
CBT,7 regardless of treatment condition. One (N ⫽ 42) that was not powered to address
potential target for optimizing the efficacy of efficacy adequately and that differed from the
existing approaches is the inclusion of interven- current study in several important ways, includ-
tion techniques to address family factors that ing a the use of a parent-focused, play-therapy
protocol designed for use with 5- to 8-year-old trials.gov (NCT00000386). Before study enrollment,
children. As a result, generalization of findings to informed consent was provided by a parent or guard-
youngsters more than 8 years of age, who com- ian and children provided assent.
prise the largest share of treatment-seeking youth
with OCD, is limited. Unfortunately, the ab- Participants
sence of rigorous comparative efficacy data for Participants 8 through 17 years were recruited from a
exposure-based CBT versus a credible psycho- pediatric OCD specialty clinic at a major university
social intervention limits conclusions about the medical center. Inclusion criteria included the follow-
efficacy of this treatment and its active ingre- ing: a primary DSM-IV diagnosis of OCD24; a CY-
dients, and impedes its potential classification BOCS total score ⬎15; an IQ ⬎70; and freedom from
as a “well-established” or even “probably effi- use of any psychotropic medication for OCD at
cacious” evidence-based intervention accord- study entry. Participants were excluded if they met
ing to current guidelines.4,10 criteria for any psychiatric illness that contraindi-
cated study participation, including suicidality, psy-
The goal of the current study was to examine,
chosis, pervasive developmental disorder, mania, or
in randomized controlled fashion, the efficacy of substance dependence.
a manualized multi-component treatment that
included individual child–focused exposure-
based CBT plus a concurrent family intervention Procedure
designed to facilitate family disengagement from Interested families completed a telephone screening to
the affected child’s OCD symptoms (FCBT) and a ascertain potential eligibility. Qualifying families were
comparison individual treatment comprising then invited to the Clinic to complete informed con-
sent/assent and a baseline eligibility evaluation. Out-
psychoeducation about OCD and systematic re-
reach efforts, including flyers, print ads, and mailings,
laxation training. The PRT included several ac-
were specifically targeted toward media outlets and
tive elements common to quality CBT to enhance providers serving predominantly minority popula-
its credibility and to provide a more stringent test tions to enhance the representativeness of the study
of FCBT. Despite earlier negative trials,13,14 more sample. Diagnostic eligibility was determined by the
recent studies have found exposure-based CBT to Anxiety Disorders Interview Schedule, Fourth Edition
be superior to psychosocial comparison treat- (ADIS-IV),25 administered along with the Children’s
ment for youth with non-OCD anxiety.21,22 Based Yale–Brown Obsessive Compulsive Scale26 and a bat-
on these studies as well as prior adult OCD tery of standardized self-report measures assessing
research,23 we hypothesized that FCBT would functional impairment, family dynamics, and comor-
prove superior to PRT in reducing OCD severity, bid symptomatology.
After completion of the baseline assessment and
associated impairment, and family accommoda-
final determination of eligibility, participants were
tion of OCD symptoms. In addition, and to
randomly assigned to either active (FCBT) or compar-
provide more information regarding the poten- ison (PRT) treatment. To minimize a potential treat-
tial mechanisms underlying FCBT, we also exam- ment by therapist confound, therapist assignment was
ined the temporal relationship between changes balanced over time so that each therapist treated
in family accommodation and changes in OCD participants in both treatment conditions. Trained
symptom severity and impairment. evaluators blinded to treatment condition conducted
assessments with families at baseline, at treatment
weeks 4 and 8, and post-treatment (week 14). Positive
responders to either intervention completed follow-up
METHOD assessments at 1 and 6 months post-treatment to
Study Design examine the durability of observed treatment gains.
A total of 71 children and adolescents were randomly
assigned to 12 sessions over 14 weeks of FCBT or PRT.
An unbalanced randomization scheme (70:30) was Treatment Conditions
employed to minimize the number of subjects receiv- Child CBT Plus Family Intervention. The Child CBT
ing comparison treatment and to facilitate planned Plus Family Intervention (FCBT) protocol consisted of
within-group secondary analyses examining therapeu- 12 sessions, 90 minutes each, delivered over 14 weeks
tic process in FCBT. The unbalanced randomization according to a detailed treatment manual since pub-
was taken into account in study power calculations. In lished.27,28 The first 10 sessions were delivered weekly
total, 49 participants were randomized to FCBT and 22 with 2-week intervals between the last two sessions to
to PRT. The trial was approved by the University foster generalization and smooth termination from
Institutional Review Board and registered on clinical treatment. The initial two sessions involved both the
patient and parents and focused on educating the treatment for either parents (FCBT [n ⫽ 48]: mean ⫽
family about OCD, presenting the treatment rationale, 5.4, SD ⫽ 1.1; PRT [n ⫽ 22]): mean ⫽ 5.0, SD ⫽ 1.7; p ⫽
creating a symptom hierarchy, and implementing a .24) or children (FCBT [n ⫽ 48]: mean ⫽ 5.0, SD ⫽ 1.4;
behavioral reward system for treatment participation. PRT (n ⫽ 22): mean ⫽ 4.5, SD ⫽ 1.6, p ⫽ .24).
Thereafter, the first hour of each session centered on
individual ERP, and the last half hour was devoted to
family sessions focusing on psychoeducation designed Therapist Training, Supervision, and Fidelity
to correct misattributions about childhood OCD, to Treatment was provided by doctoral-level psycholo-
reduce feelings of blame and guilt, and to promote gists and advanced clinical child psychology interns
increased treatment compliance and awareness. Em- with specialty training in CBT for pediatric OCD.
phasis was placed on helping parents to disengage Training began with a systematic review of study
from their child’s OCD behaviors, promoting develop- treatment manuals to ensure understanding and com-
mentally appropriate patterns of family interaction, petent delivery of all treatment procedures. Therapists
and addressing relapse prevention and maintenance of were then required to treat at least one non–study
therapeutic gains. Although both parents (or primary patient under live or videotaped observation before
caregivers) were strongly encouraged to attend all being allowed to treat study patients.
sessions, to enhance sample generalizability this was Throughout the study, therapists participated in
not an explicit requirement of participation. How- weekly group supervision and case review. All ther-
ever, at least one parent attended each FCBT session. apy sessions were videotaped, and approximately 10%
To enhance the developmental sensitivity of FCBT, of FCBT session (n ⫽ 53) videotapes, distributed
the treatment manual presented techniques in pre- evenly across the 12 treatment sessions, were ran-
ferred order of administration but provided alterna- domly selected for adherence/quality review by expe-
tive wordings and examples for different ages. The rienced CBT therapists. Sessions were rated for adher-
developmentally appropriate use of language and ence to the treatment manual (range ⫽ 0-100) and
examples was a key focus of ongoing therapist overall quality (range ⫽ 0-10) using detailed forms
supervision. developed for the study. These ratings indicated good
Psychoeducation/Relaxation Training. Participants in therapist adherence (mean ⫽ 88.2, SD ⫽ 7.9) and
PRT received training in progressive muscle relax- treatment quality (mean ⫽ 8.1, SD ⫽ 1.1).
ation29 administered according to the same schedule
as FCBT. PRT was selected as the comparison treat-
ment because of its credibility as an anxiety treat- Measures
ment13 and its acceptability to participants in a prior Anxiety Disorders Interview Schedule: Child and
adult OCD trial.23 Parent Versions. The Anxiety Disorders Interview
To further enhance the acceptability and credibility Schedule: Child and Parent Versions (ADIS:C/P)25 is a
of PRT, the first two sessions were similar to those for semi-structured psychiatric diagnostic interview ad-
FCBT and were attended by both the child and par- ministered separately to parent and child. A clinical
ents. These sessions focused on information gathering, severity rating (CSR) of 4 or higher on a 0-8 scale is
psychoeducation about OCD, presenting a treatment indicative of clinically significant disorder and was
rationale, creating an OCD symptom hierarchy, and required for an OCD diagnosis. The ADIS has demon-
developing a behavior reward system targeting com- strated sound psychometric properties.30,31 Interview-
pliance with weekly assigned practice of the relaxation ers presented child and parent-reported symptom
exercises learned in session. The remaining 10 sessions level data, but not DSM-IV diagnoses, for 37% of the
consisted of both muscular and verbally cued relax- sample (N ⫽ 26) to a best-estimate panel led by
ation techniques plus 15 minutes with parents at the licensed clinicians experienced in the evaluation of
session end to review the child’s current status and the childhood OCD.31 Although not a formal assessment
weekly homework assignments. Importantly, any in- of interrater reliability, interviewer diagnoses of OCD
struction to parents about how to manage or deal with were confirmed by the panel in 25 of 26 cases (96%).
their child’s OCD symptoms, including exposure, or Children’s Yale-Brown Obsessive Compulsive Scale.
discussion of the impact of these symptoms on family The Children’s Yale-Brown Obsessive Compulsive
functioning, was prohibited. The final session also Scale (CYBOCS)26 is a 10-item, clinician-completed
contained a “feedback” component with the child and scale (range ⫽ 0-40) assessing severity of illness over
parents to review treatment gains and strategies for the previous week. Psychometric properties are well
maintenance of gains. At the end of the first treatment documented, and the CYBOCS is considered the
session, parents and children separately rated their gold/criterion standard measure for pediatric OCD
confidence that their assigned treatment would be research.32,33
helpful using a seven-point scale (1 ⫽ not at all Clinical Global Impression-Improvement Scale.34 The
confident to 7 ⫽ extremely confident). There were no Clinical Global Impression-Improvement Scale (CGI-I)
significant differences in expectancy across the two provides a global rating of clinical improvement from
baseline with scores, ranging from 1 (very much im- Simple between-group tests were conducted with
proved) to 7 (very much worse). IEs provided CGI-I 2 and t tests. A last-observation-carried-forward ap-
ratings at each post-baseline evaluation. Participants proach was used to address missing dichotomous
receiving a CGI-I rating of 1 (very much improved) or data. For measures with four time-points of data (i.e.,
2 (much improved) by the IE at the end of treatment pretreatment, week 4, week 8, and post-treatment),
(week 14) were considered treatment responders. data were examined primarily using hierarchical linear
Child Obsessive Compulsive Impact Scale—Revised. modeling (HLM), because of the ability of HLM to model
The Child Obsessive Compulsive Impact Scale— change over time using more than two data points, to
Revised (COIS-R)35 assesses OCD-specific functional include incomplete longitudinal cases (e.g., cases with
impairment across multiple domains of youth func- only three of four repeated measures) and to include
tioning. Both the parent and child forms require re- random effects in the model. When significant between-
spondents to answer 33 items using a 0 (not at all) to 3 groups differences were found, secondary post hoc anal-
(very much) Likert scale. Both child and parent forms yses of covariance (ANCOVA) for post-treatment scores
demonstrate adequate psychometric properties includ- (controlling for baseline) were conducted, and effect sizes
ing internal consistency, concurrent validity, and test– (ES) were computed comparing post-treatment means
retest reliability.35 (MRT-MERP/SDpooled).38
Family Accommodation Scale—Parent Report. The
Family Accommodation Scale—Parent Report (FAS-
PR) is a modification of original Family Accommoda- RESULTS
tion Scale (FAS), a psychometrically sound, 13-item, Sample Characteristics
clinician-rated measure that assesses the degree to A total of 76 youngsters completed the initial
which relatives of persons with OCD have accommo- assessment, of whom 71 were deemed eligible
dated patient rituals over the preceding month.36 Fol- and randomized to FCBT or PRT (Figure 1). The
lowing the strategy used by others,15,17,37 the present two groups did not differ on any demographic or
study used a parent self-report format that was iden- clinical variables at baseline. The mean age of the
tical in scoring and content to the original FAS with
participants was 12.2 years (SD ⫽ 2.5 years);
items rated on a five-point (0-4) Likert scale. The
36.6% were male, and 77.5% were Caucasian.
FAS-PR was reliable in the present sample (␣ ⫽ 0.88).
Approximately 25% of the sample had a prior
history of psychotropic medication use, and six
Interviewer Training, Supervision, and Reliability individuals (8.5%) were on stable regimens of
Interviewers were doctoral-level clinical psychologists non-OCD medications at study entry (Table 1).
or graduate students with prior training or experience Two-thirds (66.2%) of the sample met criteria
in the assessment of childhood anxiety. Training in- for another DSM-IV diagnosis at entry, with
volved attending a presentation on the administration almost 30% meeting criteria for two or more
of the ADIS, CYBOCS, and CGI-I, observing and additional disorders (Table 2). Collectively, non-
coding a videotaped interview, co-rating multiple live OCD anxiety disorders were most common
interviews conducted by a trained diagnostician, and (46.5%), with generalized anxiety disorder the
following satisfactory completion of the earlier steps, most common single co-occurring diagnosis
conducting at least one evaluation while under the
(33.8%). Although a primary (e.g., most impair-
supervision of a trained diagnostician. Interviewers
received ongoing group supervision over the course of
ing) diagnosis of OCD was a requirement of
the study. Independent rating of 37% of randomly study entry, subsequent inspection revealed the
selected CYBOCS audiotapes indicated excellent inter- inadvertent inclusion of one child with a diagno-
rater reliability for this measure at baseline (N ⫽ 26; sis of intermittent explosive disorder (IED) rated
ICC ⫽ 0.96) and post-treatment (N ⫽ 23; ICC ⫽ 0.99). as marginally more impairing than OCD. Given
this near equivalence in severity and the fact that
the child was otherwise eligible for the study,
Statistical Analyses these data were retained for subsequent analyses.
Sample size determination was based on expected
intent-to-treat response rates on the primary outcome
Responder Status
measure (CGI-I), of 60% for FCBT and 25% for PRT,
70:30 randomization to active and comparison treat-
Intent-to-treat analyses with the CGI-I revealed a
ment respectively, and a significance level of p ⬍ .05. significantly higher response rate at week 14 for
Based on these assumptions, a total sample size of 72 FCBT as compared with PRT (57.1% versus
(FCBT, n ⫽ 50; PRT, n ⫽ 22) was determined to 27.3%; 2 ⫽ 5.40, p ⬍ .05). Analysis of treatment
provide 82% power to detect at least a 35% between completers yielded similar results (68.3% versus
group difference in treatment response rate.38 35.3%, 2 ⫽ 5.40, p ⬍ .05).
FIGURE 1 Study enrollment and retention. Note: FCBT ⫽ Child Cognitive Behavioral Therapy Plus Family
Intervention; FU ⫽ follow-up; PRT ⫽ Psychoeducation plus Relaxation Training.
TABLE 1 Baseline Sample Demographics and Clinical TABLE 2 Diagnostic Status at Baseline
Characteristics
Total FCBT PRT
Total FCBT PRT (N ⴝ 71) (N ⴝ 49) (N ⴝ 22)
(N ⴝ 71) (N ⴝ 49) (N ⴝ 22) n (%) n (%) n (%)
Mean age (SD) 12.2 (2.5) 12.4 (2.6) 11.6 (2.0) Tic disorder 8 (11.3) 6 (12.2) 2 (9.1)
Gender (%) Tourette disorder 3 (4.2) 3 (6.1) 0 (0.0)
Male 36.6 40.8 27.3 Chronic motor tic 3 (4.2) 2 (4.1) 1 (4.5)
Female 63.4 59.2 72.7 disorder
Ethnicity (%) Transient tic disorder 2 (2.8) 1 (2.0) 1 (4.5)
White 77.5 77.6 77.3 Anxiety disorder 33 (46.5) 26 (53.1) 7 (31.8)
Latino 9.9 10.2 9.1 Generalized anxiety 24 (33.8) 18 (36.7) 6 (27.3)
Asian 4.2 4.1 4.5 Social anxiety 9 (13.9) 5 (10.2) 4 (18.2)
African American 2.8 2.0 4.5 Separation anxiety 7 (9.9) 5 (10.2) 2 (9.1)
Other/Mixed 5.6 6.1 4.5 Specific phobia 5 (7.0) 2 (4.1) 3 (13.6)
Current Living Panic 1 (1.4) 1 (2.0) 0 (0.0)
Situation (%) ADHD 9 (13.9) 7 (14.3) 2 (9.1)
Both biological 73.2 67.3 86.4 Combined type 6 (8.5) 5 (10.2) 1 (4.5)
parents Inattentive type 3 (4.2) 2 (4.1) 1 (4.5)
Single parent 18.3 22.4 9.1 Oppositional defiant 3 (4.2) 2 (4.1) 1 (4.5)
Other 8.5 10.2 4.5 disorder
Prior medication Mood disorder 3 (4.2) 3 (6.1) 0 (0.0)
history (%) Dysthymia 2 (2.8) 2 (4.1) 0 (0.0)
Any psychiatric 25.4 22.4 31.8 Major depressive 1 (1.4) 1 (2.0) 0 (0.0)
SSRI/SRI 21.1 20.4 22.7 episode
Stimulant 7.0 6.1 9.1 Other 2 (2.8) 0 (0.0) 2 (9.1)
Other 3.7 4.1 9.1 Number of co-occurring
On current 8.5 9.1 8.5 diagnoses
medication (%)a None 24 (33.8) 15 (30.6) 9 (40.9)
Obsessions (%) One 26 (36.6) 20 (40.8) 6 (27.3)
Contamination 71.8 65.3 86.4 Two 15 (21.1) 11 (22.4) 4 (18.2)
Aggressive 78.9 75.5 86.4 Three 6 (8.4) 3 (6.1) 3 (13.6)
Sexual 18.3 16.3 22.7
Note: ADHD ⫽ attention-deficit/hyperactivity disorder; FCBT ⫽ Child
Hoarding 33.8 34.7 31.8
Cognitive Behavioral Therapy Plus Family Intervention; PRT ⫽ Psy-
Superstitious 28.2 30.6 22.7
choeducation plus Relaxation Training.
Somatic 49.3 40.8 68.2
Religious 50.7 46.9 59.1
Miscellaneous 73.2 71.4 77.3
Compulsions(%)
Cleaning 67.6 63.3 77.3
The COIS-RC does not have established clin-
Checking 63.4 61.2 68.2
Repeating 69.0 75.5 54.6
ical cut-points; therefore, to evaluate the clini-
Counting 30.7 26.5 40.1 cal significance of observed changes, treatment
Ordering 70.4 69.4 72.7 completers were grouped according to whether
Hoarding 38.0 34.7 45.5 they either had no COIS items scored above 1
Superstitious 28.1 26.5 31.8 at post-treatment (i.e., no more than minimal
Involving others 69.0 67.4 72.7 OC-related impairment in any functional) or
Miscellaneous 94.4 93.9 95.5 whether they had any COIS items scored above
Note: Contamination and Somatic Obsessions were significantly more
1 (reflecting more than minimal impairment).
common in Psychoeducation plus Relaxation Training (PRT) vs Child In FCBT, 24 children (66.7%) reported minimal
Cognitive Behavioral Therapy Plus Family Intervention (FCBT) (p ⬍ impairment on the COIS-RC, whereas 12
.05). SSRI/SRI ⫽ Selective Serotonin Reuptake Inhibitor/Serotonin (33.3%) reported more than minimal impair-
Reuptake Inhibitor.
ment. In contrast, only a minority of children
a
Current Medication: FCBT: methylphenidate ⫽ 3, trazodone (report-
edly for sleep) ⫽ 1; PRT: Adderall ⫽ 1, clonodine (reportedly for who received PRT (n ⫽ 5; 31.3%) reported
tics) ⫽ 1. minimal impairment on the COIS-RC, whereas
11 (68.8%) reported more than minimal impair-
ment (2 ⫽ 5.63, p ⬍ .05).
TABLE 3 Numbers, Means, 95% Confidence Intervals, and Within-Group Effect Sizes (d) for Study Outcome
Measures by Treatment Condition and Week
FCBT PRT
CYBOCS
Week 0 49 24.7 (23.4–26.1) 22 25.3 (23.4–27.2)
Week 4 48 21.7 (20.2–23.2) 20 23.5 (21.2–25.8)
Week 8 43 18.6 (16.5–20.7) 17 18.9 (15.2–22.6)
Week 14 40 13.3 (10.7–15.9) 17 17.2 (13.0–21.4)
d ⫽ 2.37 d ⫽ 1.80
COIS-RC
Week 0 48 15.4 (12.8–18.8) 22 14.9 (9.2–20.6)
Week 4 48 10.9 (8.4–13.4) 20 11.6 (6.5–16.7)
Week 8 42 9.2 (6.3–12.1) 16 15.5 (9.1–21.9)
Week 14 39 5.6 (3.3–8.0) 16 14.3 (8.0–20.6)
d ⫽ 0.81 d ⫽ 0.05
COIS-RP
Week 0 47 22.4 (19.0–25.8) 22 21.4 (13.8–29.0)
Week 4 48 21.2 (17.2–25.2) 21 20.5 (13.8–27.2)
Week 8 43 17.4 (13.0–21.8) 17 16.2 (10.4–22.0)
Week 14 39 10.6 (7.1–14.1) 17 11.2 (7.3–15.1)
d ⫽ 1.01 d ⫽ 0.57
FAS-PR
Week 0 48 17.5 (14.5–20.5) 22 18.0 (13.7–22.3)
Week 14 39 9.3 (6.4–12.2) 17 15.2 (10.5–19.9)
d ⫽ 0.78 d ⫽ 0.27
Note: COIS-R ⫽ Child Obsessive Compulsive Impact Scale—Revised Parent-Report; COIS-RC ⫽ Child Obsessive Compulsive Impact Scale—Revised
Child-Report; CYBOCS ⫽ Children’s Yale–Brown Obsessive Compulsive Scale; FAS-PR ⫽ Family Accommodation Scale—Parent Report; FCBT ⫽ Child
Cognitive Behavioral Therapy Plus Family Intervention; PRT ⫽ Psychoeducation plus Relaxation Training.
FIGURE 2 Change in Children’s Yale–Brown Obsessive Compulsive Scale (CYBOCS) total score by treatment
condition over time. Note: FCBT ⫽ Child Cognitive Behavioral Therapy Plus Family Intervention; PRT ⫽
Psychoeducation plus Relaxation Training.
ing assessment. This effect was reduced by more these 26 subjects were as follows: post-treatment:
than 50%, to a 0.48-point corresponding reduc- mean ⫽ 9.7 (95% CI ⫽ 6.0-12.0); 1-month follow-
tion in COIS-RC scores in the PRT group. There up: mean ⫽ 4.1 (95% CI ⫽ 2.8-5.3); 6-month
was no significant effect found in the COIS-RP follow-up: mean ⫽ 3.2 (95% CI ⫽ 1.8-4.5). Of the
model. six PRT responders, five (83%) completed the 1-
and 6-month follow-up assessments, although
CGI-I data were missing for one subject at 6
Durability of Treatment Response
months. Overall, 60% (3/5) maintained their
Of 28 initial FCBT responders, 26 (93%) com-
positive response at 1 month and 75% (3/4) at
pleted follow-up assessments, with 81% (21/26)
6 months. Mean CYBOCS total scores for these
maintaining their positive response status (CGI-I
subjects were as follows: post-treatment: mean ⫽
⬍3) at 1 month and 73% (19/26) at 6 months
9.8 (95% CI ⫽ 5.3-14.3); 1-month follow-up:
post-treatment. Mean CYBOCS total scores for
mean ⫽ 4.2 (95% CI ⫽ 1.1-7.3); 6-month follow-
up: mean ⫽ 3.4 (95% CI ⫽ ⫺0.6-7.4).
TABLE 4 Response Status as Determined by Week 14
Children’s Yale–Brown Obsessive Compulsive Scale DISCUSSION
(CYBOCS) Total Score
This study tested the efficacy of a family-focused
CYBOCS FCBT PRT CBT protocol (FCBT) for pediatric OCD com-
Total Score n (%) n (%) pared with a credible psychosocial comparison
treatment involving OCD psychoeducation and
0–10 (Remitted) 17 (42.5) 3 (17.6)
11–15 (Subclinical) 10 (25.0) 5 (29.4)
relaxation training (PRT). As expected, primary
16–24 (Moderately ill) 10 (25.0) 5 (29.4) analyses found that youth receiving FCBT dem-
24–40 (Severely ill) 3 (7.5) 4 (23.5) onstrated larger overall response rates and more
rapid reduction of OCD symptom severity and
Note: FCBT ⫽ Child Cognitive Behavioral Therapy Plus Family Interven- child-reported functional impairment than those
tion; PRT ⫽ Psychoeducation plus Relaxation Training.
receiving PRT. Moreover, FCBT was associated
with more rapid decreases in family accommo- tions,7,20 the present findings suggest that one
dation than PRT. These findings were confirmed should use caution in interpreting the existing
in some, but not all, secondary analyses. Changes literature, and the findings speak to the impor-
in family accommodation temporally preceded re- tance of more methodologically rigorous treat-
ductions in CYBOCS symptom severity for both ment designs going forward. Importantly, and in
FCBT and PRT. However, reduced accommodation line with prior negative trials using active com-
preceded improvement in child-reported OC- parison treatments,13,14 the relatively large effect
specific functional impairment only for FCBT. To sizes for PRT may have contributed to the lack of
our knowledge, this is the first controlled demon- significant post-treatment ANCOVA findings.
stration of the temporal ordering of changes in It is also encouraging to note that FCBT was
family accommodation and outcome in a pediatric associated with significant reductions in both
sample. FCBT was associated with a twofold parent and child-reported, OC-specific functional
greater rate of remission of OCD than PRT (43% impairment. However, PRT was also associated
versus 18%, respectively). In addition, acute re- with a significant reduction in parent- but not
sponders in both conditions maintained their gains child-reported impairment, such that the treat-
over the 6-month follow-up interval providing ment by time interaction was significant only for
some evidence for the durability and clinical sig- child-reported impairment. The reasons for this
nificance of initial treatment response. Controlled discrepancy are not immediately clear. The most
examination of response durability over longer parsimonious explanation is that children are
follow-up periods is needed to better determine simply more accurate reporters of their psychos-
the long range and specific impact of successful ocial functioning than parents. However, it is
CBT on course of disorder, impairment, and also possible that PRT may have facilitated an
other outcomes. increased level of psychosocial functioning in
On a broader level, findings from this study are children that was noted by parents, but not
consistent with the existing literature. In particular, reported by the children themselves perhaps
the response and remission rates demonstrated for because these activities were still distressing to
FCBT largely parallel those from other randomized accomplish. Alternatively, differential treatment
controlled CBT trials4,7,20 and suggest that exposure- effects on functioning may require longer periods
based CBT is an efficacious and potentially du- of observation by parents to detect than our 14
rable39 treatment for pediatric OCD in the major- week acute phase allowed. There has been growing
ity of cases. Moreover, the use of an active emphasis on the importance of addressing func-
comparator strategy designed to control for sev- tional outcomes,1,2 and, regardless of the mecha-
eral critical elements of exposure-based treat- nism underlying the functional changes observed
ment extends prior research and serves to in- in the present study, these findings speak to the
crease confidence in study findings as well as the value of FCBT in reducing OCD-related interfer-
conceptual model underlying this treatment ence and enhancing global functioning.
approach.10 The present findings also shed light on family
The magnitude of the between-group effect processes that may influence treatment outcome
size (d ⫽ 0.4) found for FCBT in this trial also for youth with OCD. Accommodation is well
needs to be evaluated in the context of the study documented among families of youth with
comparison group. Although the within-group OCD15,16,17 and is hypothesized to undermine
ES for FCBT (2.4) was comparable to those from the success of exposure-based CBT. Nonetheless,
other controlled pediatric OCD trials (e.g., 2.6,7 prior controlled efforts to change family dynam-
2.2,20 and 3.6,12), the within-group ES found for ics have produced largely negative results. The
PRT in this study (1.8) was far superior to those present findings are encouraging in that they
reported for comparison conditions used in other provide the first controlled evidence that weekly
controlled studies (e.g., ⫺0.20 for waitlist,12 1.0 treatment with brief, individual child CBT in
for relaxation training,20 and 1.1 for pill pla- combination with a structured family interven-
cebo7). Notably, PRT outperformed the POTS tion can reduce parent-reported involvement in
sertraline-only condition, which yielded a within- OC symptoms, and that this reduction in accom-
treatment ES of only 1.3.7 Although the pediatric modation may precede improvement in both
OCD research community has been moving to- symptom severity and OCD-related functional
wards the use of more active comparison condi- impairment. However, the fact that the treatment
group by slope interaction was only marginally treatment development and refinement for nonre-
significant (p ⫽ .05) does not allow us to conclude sponders to initial intervention.
that the reductions in accommodation that pre- Despite the methodological strengths noted
ceded OCD symptom reduction are specific to earlier, along with careful quality adherence pro-
the FCBT group only. Whether this is actually the cedures, therapist assignment balanced across
case or the result of insufficient statistical power conditions, and a largely medication-free and
remains to be established. relatively ethnically heterogeneous sample, a
Although FCBT was designed to reduce fam- number of study limitations must also be noted.
ily accommodation to support the child’s ability First, the study design did not allow for a con-
to engage in exposure plus response prevention, trolled evaluation of treatment durability as eth-
it is also not possible at present to rule out the ical concerns led us to remove nonresponders
alternative hypothesis that reductions in OCD from the study to week 14 in order to provide
severity resulting from individual child treat- them with clinical treatment. Second, the lack of
ment instead led to decreased family involve- parent and child treatment credibility ratings
ment independent of the family intervention, or does not exclude the possibility that between-
that the observed effects are reciprocal or bidi- group treatment differences were influenced by
rectional in nature, particularly in light of the fact informant bias towards FCBT. However, this
that a group by time interaction effect on the concern is at least partially mitigated by the fact
time-varying covariate analyses were only signif- that parent and child ratings of expected benefits
icant for functional impairment and not for were reasonably high and did not significantly
symptom severity. Although failure to demon- differ across the two conditions. In addition,
strate a specific temporal relationship between because the same therapists provided both treat-
reduced accommodation and symptom severity ments, it is also possible that, despite efforts to
for FCBT may have been due to inadequate prevent this, active elements of FCBT may have
statistical power, clarification of this conundrum inadvertently bled into the PRT protocol and led
requires additional study. to some proportion of the positive effects associ-
Even though prior FCBT studies for childhood ated with the comparison treatment. The lack of
OCD have produced encouraging results, the therapist adherence ratings for PRT does not
present findings have important implications allow us to examine this concern directly. How-
for furthering the classification of FCBT as an ever, the potential therapist-by-treatment con-
evidence-based intervention.10 Both expert con- found resulting from restricting therapists to one
sensus and professional-group guidelines have condition only is arguably a far greater, and less
recommended some degree of family involve- controllable, threat to the internal validity of the
ment in child OCD treatment40,41; however, study than potential bleed. Third, while enhanc-
empirical support for these recommendations ing the representativeness of the sample to more
remains limited.4 Our use of an adequately pow- typical treatment settings, our decision to not ex-
ered randomized design, systematic standard- plicitly require both parents to attend each FCBT
ized assessment, and a credible comparison session likely resulted in a less than ideal dose of
group qualify this study for Type 1 methodolog- the family intervention in some cases. Decisions
ical classification11 and provide the necessary such as these speak to the difficulty in balancing
evidence to elevate FCBT from a “possibly effi- internal and external validity needs.
cacious” to a “probably efficacious” treatment for Finally, although the study was powered to
childhood OCD.4,10 Although this may seem to address primary aims, the study sample size, espe-
be little more than an incremental advance, the cially in light of the relative potency of PRT, limited
determination of FCBT as a “probably effica- the statistical power available for some secondary
cious” treatment is particularly important in a study analyses, did not allow us to examine pre-
field where scientifically untested interventions dictors in a more comprehensive manner or allow
are common and clinical outcomes often leave definitive conclusions to be drawn from all of the
much to be desired. However, we also note that, predictor analyses that were conducted.
similar to the POTS Study,7 more than 40% of It is also important to note that the current study
subjects receiving FCBT failed to achieve responder design does not allow us to estimate the incremen-
status, highlighting the variable response to pedi- tal benefit of FCBT over more traditional individual
atric OCD treatment and the need for additional child CBT; such trials have yet to be published for
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