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Trial record 42 of 87 for:    Developmental Disabilities | ( Map: Canada )

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

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ClinicalTrials.gov Identifier: NCT03123146
Recruitment Status : Completed
First Posted : April 21, 2017
Last Update Posted : April 21, 2017
Sponsor:
Collaborators:
Ontario Mental Health Foundation
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Tricia Vause, Brock University

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Obsessive-Compulsive Behavior Behavioral: Functional Behavior-Based Cognitive Behavioral Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional Behavior-based Cognitive-Behavioral Therapy for Obsessive Compulsive Behavior in Children With Autism Spectrum Disorder: A Randomized Controlled Trial
Actual Study Start Date : June 1, 2010
Actual Primary Completion Date : February 1, 2014
Actual Study Completion Date : February 1, 2014

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123146


Locations
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Canada, Ontario
Brock University
St Catharines, Ontario, Canada, L2S3A1
Sponsors and Collaborators
Tricia Vause
Ontario Mental Health Foundation
Ontario Ministry of Health and Long Term Care
Investigators
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Principal Investigator: Tricia Vause, PhD Brock University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tricia Vause, Associate Professor, Brock University
ClinicalTrials.gov Identifier: NCT03123146     History of Changes
Other Study ID Numbers: 09-066-VAUSE
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tricia Vause, Brock University:
Cognitive Behavioral Therapy
Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Compulsive Behavior
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Impulsive Behavior