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Clinical Trials/NCT01635569
NCT01635569
Recruiting
N/A

Clinical Outcomes Following Group-based Family Cognitive-Behaviour Therapy in Pediatric Obsessive-Compulsive Disorder (OCD)

University of British Columbia1 site in 1 country180 target enrollmentOctober 1, 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obsessive-compulsive Disorder
Sponsor
University of British Columbia
Enrollment
180
Locations
1
Primary Endpoint
Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS)
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Obsessive-Compulsive Disorder (OCD) is a common neuropsychiatric illness beginning in childhood. Effective OCD treatments include cognitive-behaviour therapy (CBT) and medications but access to treatment is difficult and does not systematically include parents. The investigators will evaluate clinical and neural effects of Group-based Family CBT (GF-CBT), via a case-control study including: Group 1 - OCD cases receiving GF-CBT (N=90); Group 2 - OCD waitlist cases (N=90). Effects will be measured between baseline and completion of 12 GF-CBT sessions: comparing OCD severity and functioning changes between Groups 1 and 2.

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
October 1, 2012
End Date
June 2027
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Evelyn Stewart, MD

Principle Investigator

University of British Columbia

Eligibility Criteria

Inclusion Criteria

  • Male or female, aged 5-18 years old
  • Ability of subject and parent to provide informed assent/consent
  • English-speaking
  • Current DSM IV-TR Axis I diagnosis of childhood-onset OCD; Moderate to severe OCD (CY-BOCS≥16/40)

Exclusion Criteria

  • Current diagnosis of bipolar disorder, psychosis, mental retardation or pervasive developmental disorder (e.g., autism), and current or past substance dependence/abuse

Outcomes

Primary Outcomes

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 Sites (1)

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