Skip to main content
OpenTrials
Completed

NCT Number: NCT03123146

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Spectrum Disorder Behavior Child Development Disorders, Pervasive Compulsive Behavior Impulsive Behavior Mental Disorders Neurodevelopmental Disorders Obsessive-Compulsive Behavior

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brock University

St. Catharines, Ontario, L2S3A1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Behavior-Based Cognitive Behavioral Therapy

Behavioral

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.

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

Tricia Vause

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Apr 21, 2017
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.