Clinical trial NCT03123146: Cognitive Behavioural Therapy for Children With Autism Spectrum Disorder and Obsessive Compulsive Behaviour
Official title: Functional Behavior-based Cognitive-Behavioral Therapy for Obsessive Compulsive Behavior in Children With Autism Spectrum Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Obsessive-Compulsive Behavior
Keywords: Cognitive Behavioral Therapy
Lead sponsor: Brock University
Sponsor class: OTHER
Collaborators: name: Ontario Mental Health Foundation
name: Ontario Ministry of Health and Long Term Care
First posted: 2017-04-21
Enrollment: 37
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Individuals with high functioning autism spectrum disorder (ASD) frequently experience obsessions and/or compulsions that are similar to those specified in Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5) criteria for obsessive compulsive disorder (OCD). However, little research exists on effective interventions for OCD symptoms (referred to as OCBs) in ASD. In a randomized controlled trial, a manualized functional behavior-based cognitive-behavior therapy (Fb-CBT) consisting of traditional CBT components (psychoeducation and mapping, cognitive-behavioral skills training, exposure, and response prevention) as well as function-based behavioral assessment will be evaluated. Participants will be assigned randomly to Fb-CBT or treatment as usual (TAU). Primary and secondary outcome measures will be used to evaluate the efficacy of the treatment, and will be administered at pre and post-intervention as well as six month follow-up.


Eligibility criteria: Inclusion Criteria:

* Previous diagnosis of ASD
* Presence of OCBs as defined by Sameness, Ritualistic and Compulsive subscales on the RBS-R
* a Full Scale IQ (WISC-IV; Wechsler, 2004) ≥ 70
* parent indicated no planned change in child medication during the study (unless the physician deemed the change medically necessary)

Exclusion Criteria:

* participation in treatment for anxiety
* participation in treatment for repetitive behaviour
* participation in treatment for intensive behavioural intervention

Primary outcomes:
measure: Change in Repetitive Behavior Scale (RBS_SCR)
timeFrame: Assessment occurred at baseline and 2 weeks following end of treatment, as well as at follow-up (6 months following the cessation of treatment)
measure: Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
timeFrame: Assessment occurred at baseline and 2 weeks following end of treatment
Secondary outcomes:
measure: Change in Repetitive Behavior Scale 100 (RBS_100)
timeFrame: Assessment occurred at baseline and 2 weeks following the end of treatment, as well as at follow-up (6 months following the cessation of treatment)
measure: Change in The child Obsessive-Compulsive Impact Scale-Revised (COIS-R)
timeFrame: Assessment occurred at baseline and 2-weeks following the end of treatment, as well as at follow-up (6 months following the cessation of treatment)
measure: Parent OCB Rating Scale.
timeFrame: Scale was completed by parents at baseline, each day throughout the 9-week treatment period, and at follow-up (6 months following the cessation of treatment)
Other outcomes:
Locations:
city: St Catharines
country: Canada
facility: Brock University
state: Ontario
Study officials:
affiliation: Brock University
name: Tricia Vause, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vause T, Jaksic H, Neil N, Frijters JC, Jackiewicz G, Feldman M. Functional Behavior-Based Cognitive-Behavioral Therapy for Obsessive Compulsive Behavior in Children with Autism Spectrum Disorder: A Randomized Controlled Trial. J Autism Dev Disord. 2020 Jul;50(7):2375-2388. doi: 10.1007/s10803-018-3772-x.