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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03123146
Other study ID # 09-066-VAUSE
Secondary ID
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
Health authority
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

Study Design


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)
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