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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
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Obsessive-compulsive Disorder Behavioral: Group-based family cognitive-behavioural therapy Other: Waitlist

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).

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Other: Waitlist
Baseline and post-12 sessions

Outcome Measures

Primary Outcome Measures :
  1. 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.

Eligibility Criteria

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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): NCT01635569

Contact: Diana Franco Yamin, MA dfrancoy@bcchr.ca

Canada, British Columbia
BC Children's Hospital Research Institute Recruiting
Vancouver, British Columbia, Canada
Principal Investigator: S. Evelyn Stewart, MD         
Sponsors and Collaborators
University of British Columbia
Michael Smith Foundation for Health Research
Principal Investigator: S. Evelyn Stewart, MD University of British Columbia
More Information

Responsible Party: Evelyn Stewart, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01635569     History of Changes
Other Study ID Numbers: H12-01656
First Posted: July 9, 2012    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017

Keywords provided by Evelyn Stewart, University of British Columbia:
Obsessive-compulsive disorder
Cognitive-behavioural therapy

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders