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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03123146
• Other study ID #: 09-066-VAUSE
• Status: Completed
• Phase: N/A
• First received: April 13, 2017
• Last updated: April 19, 2017
• Start date: June 1, 2010
• Est. completion date: February 1, 2014

Study information

• Verified date: April 2017
• Source: Brock University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 1, 2014
• Est. primary completion date: February 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Compulsive Behavior
• Disease
• Obsessive-Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

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.

Locations

Country	Name	City	State
Canada	Brock University	St Catharines	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Tricia Vause	Ontario Mental Health Foundation, Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Repetitive Behavior Scale (RBS_SCR)	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)
Primary	Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)	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	Change in Repetitive Behavior Scale 100 (RBS_100)	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)
Secondary	Change in The child Obsessive-Compulsive Impact Scale-Revised (COIS-R)	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)
Secondary	Parent OCB Rating Scale.	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)