Cognitive Behavioural Therapy for Children With Autism Spectrum Disorder and Obsessive Compulsive Behaviour

April 19, 2017 updated by: Tricia Vause

Functional Behavior-based Cognitive-Behavioral Therapy for Obsessive Compulsive Behavior in Children With Autism Spectrum Disorder: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • St Catharines, Ontario, Canada, L2S3A1
        • Brock University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fb-Cognitive Behavioral Therapy
Functional Behavior-Based Cognitive Behavioral Therapy: Group activities, individual work in parent-child dyads, group parent training, and social skills exercises.
Behavioral: Functional Behavior-Based Cognitive Behavioral Therapy
Fb-CBT involved nine 2-hour weekly sessions with three to four children in each group and two therapists. Therapy consisted of group activities, individual work in parent-child dyads, group parent training, and social skills exercises.
No Intervention: Treatment as Usual (TAU)
Children assigned to this condition received "usual care," meaning that they could continue with any services. This group acted as a control group whereby access to intervention was patient-directed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Repetitive Behavior Scale (RBS_SCR)
Time Frame: Assessment occurred at baseline and 2 weeks following end of treatment, as well as at follow-up (6 months following the cessation of treatment)
The RBS is a 43-item parent rating measure of repetitive behavior. It is comprised of a four-point Likert scale ranging from (0) behavior does not occur, to (3) behavior occurs and is a severe problem . The RBS_SCR scale specifically focusses on the assessment of sameness, compulsive, and ritualistic behaviors
Assessment occurred at baseline and 2 weeks following end of treatment, as well as at follow-up (6 months following the cessation of treatment)
Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
Time Frame: Assessment occurred at baseline and 2 weeks following end of treatment
A 10-item, semi-structured interview used to assess symptom severity for children ages 6 through 17 years. Each item is rated on a 5-point ordinal scale from 0 (none) to 4 (extreme)' For the purpose of this study, only the 5-item Compulsion score was used pre and post-treatment.
Assessment occurred at baseline and 2 weeks following end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Repetitive Behavior Scale 100 (RBS_100)
Time Frame: 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)
The final item on the RBS-R asks caregivers to rate on a scale from 1 to 100 how much OCBs affect the child and the people around them (1 is not a problem to 100 is as bad as can be imagined; Bodfish et al., 1999).
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)
Change in The child Obsessive-Compulsive Impact Scale-Revised (COIS-R)
Time Frame: 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)
A 33-item, parent-report questionnaire that assesses OCD-related impairment in various areas of the child's life, including school, social, and home/family activities. For each item, the parent rates the child's level of impairment on a 4-point Likert scale from 0 (not at all) to 3 (very much).
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)
Parent OCB Rating Scale.
Time Frame: 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)
A Likert-type scale ranging from 1 (desired post-treatment levels of OCBs) to 3 (partial improvement from pre-treatment levels) to 5 (pre-treatment levels of OCBs) was used by parents to rate OCBs.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tricia Vause

Collaborators

Ontario Ministry of Health and Long Term Care
Ontario Mental Health Foundation

Investigators

  • Principal Investigator: Tricia Vause, PhD, Brock University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2010

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

April 13, 2017

First Submitted That Met QC Criteria

April 19, 2017

First Posted (Actual)

April 21, 2017

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-066-VAUSE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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