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

Primary Purpose

Autism Spectrum Disorder, Obsessive-Compulsive Behavior

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Functional Behavior-Based Cognitive Behavioral Therapy
Sponsored by
Tricia Vause
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Cognitive Behavioral Therapy

Eligibility Criteria

7 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brock University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fb-Cognitive Behavioral Therapy

Treatment as Usual (TAU)

Arm Description

Functional Behavior-Based Cognitive Behavioral Therapy: Group activities, individual work in parent-child dyads, group parent training, and social skills exercises.

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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).
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).
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.

Full Information

First Posted
April 13, 2017
Last Updated
April 19, 2017
Sponsor
Tricia Vause
Collaborators
Ontario Mental Health Foundation, Ontario Ministry of Health and Long Term Care
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1. Study Identification

Unique Protocol Identification Number
NCT03123146
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2010 (Actual)
Primary Completion Date
February 1, 2014 (Actual)
Study Completion Date
February 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tricia Vause
Collaborators
Ontario Mental Health Foundation, Ontario Ministry of Health and Long Term Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Obsessive-Compulsive Behavior
Keywords
Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fb-Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
Functional Behavior-Based Cognitive Behavioral Therapy: Group activities, individual work in parent-child dyads, group parent training, and social skills exercises.
Arm Title
Treatment as Usual (TAU)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Functional Behavior-Based Cognitive Behavioral Therapy
Intervention Description
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 Outcome Measure Information:
Title
Change in Repetitive Behavior Scale (RBS_SCR)
Description
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
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)
Title
Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
Description
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.
Time Frame
Assessment occurred at baseline and 2 weeks following end of treatment
Secondary Outcome Measure Information:
Title
Change in Repetitive Behavior Scale 100 (RBS_100)
Description
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).
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)
Title
Change in The child Obsessive-Compulsive Impact Scale-Revised (COIS-R)
Description
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).
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)
Title
Parent OCB Rating Scale.
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tricia Vause, PhD
Organizational Affiliation
Brock University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brock University
City
St Catharines
State/Province
Ontario
ZIP/Postal Code
L2S3A1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
30293128
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.
Results Reference
derived

Learn more about this trial

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

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