Clinical Outcomes in Pediatric Obsessive-Compulsive Disorder
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|ClinicalTrials.gov Identifier: NCT01635569|
Recruitment Status : Recruiting
First Posted : July 9, 2012
Last Update Posted : July 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obsessive-compulsive Disorder||Behavioral: Group-based family cognitive-behavioural therapy Other: Waitlist||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Outcomes Following Group-based Family Cognitive-Behaviour Therapy in Pediatric Obsessive-Compulsive Disorder (OCD)|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2019|
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
- 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.
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): NCT01635569
|Contact: Diana Franco Yamin, MAemail@example.com|
|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|