Clinical Outcomes in Pediatric Obsessive-Compulsive Disorder
|Obsessive-compulsive Disorder||Behavioral: Group-based family cognitive-behavioural therapy Other: Waitlist|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Clinical Outcomes Following Group-based Family Cognitive-Behaviour Therapy in Pediatric Obsessive-Compulsive Disorder (OCD)|
- Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS) [ Time Frame: Baseline, midpoint, completion of 12 GF-CBT sessions, one-month follow-up ]CY-BOCS: gold-standard measure of OCD severity in pediatric OCD.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||June 2019|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Active Comparator: OCD-affected subjects (Group 1)
OCD-affected subjects will participate in 12 sessions of group therapy (as per GF-CBT protocol).
Behavioral: Group-based family cognitive-behavioural therapy
Baseline and post-12 sessions
Active Comparator: OCD-affected subjects (Group 2)
Waitlist affected-controls awaiting a treatment spot.
Baseline and post-12 sessions
Effective OCD treatment approaches in children and youth include cognitive-behaviour therapy (CBT) and serotonergic medications; however, the disorder is under-diagnosed and access to care is frequently delayed or difficult to obtain. Moreover, despite the important role of family accommodation as an outcome predictor, standard CBT does not systematically include parents and mechanisms of response are not fully understood. The investigators propose to address this challenge by evaluating a novel treatment approach called Group-based Family CBT (GF-CBT).
To determine clinical and neural effects of GF-CBT, we will perform a case-control study of two groups: Group 1 - OCD-affected youth receiving GF-CBT treatment (N=90); Group 2 - OCD-affected youth receiving no new treatment (waitlist controls; N=90).
The investigators will collect clinical outcome data related to OCD severity, individual and family functioning at four time points for Group 1 subjects and at two time points for Group 2 subjects. For Group 1 subjects, these time points include baseline, at midpoint, at the completion of 12 sessions, and at one-month follow-up (all time points are +/- one week). For Group 2 subjects, time points will be at baseline and after a time delay equivalent to completion of 12 GF-CBT sessions. Clinical measures will be used to compare changes between GF-CBT treatment and waitlist-control groups (Groups 1 versus 2).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01635569
|Contact: Diana Franco Yamin, MAfirstname.lastname@example.org|
|Canada, British Columbia|
|BC Children's Hospital Research Institute||Recruiting|
|Vancouver, British Columbia, Canada|
|Principal Investigator: S. Evelyn Stewart, MD|
|Principal Investigator:||S. Evelyn Stewart, MD||University of British Columbia|