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Clinical Outcomes in Pediatric Obsessive-Compulsive Disorder

This study is currently recruiting participants.
Verified July 2017 by Evelyn Stewart, University of British Columbia
Sponsor:
ClinicalTrials.gov Identifier:
NCT01635569
First Posted: July 9, 2012
Last Update Posted: July 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Michael Smith Foundation for Health Research
Information provided by (Responsible Party):
Evelyn Stewart, University of British Columbia
  Purpose
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 Intervention
Obsessive-compulsive Disorder Behavioral: Group-based family cognitive-behavioural therapy Other: Waitlist

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Evelyn Stewart, University of British Columbia:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 180
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)
Arms Assigned Interventions
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

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).

  Eligibility

Information from the National Library of Medicine

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


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

Locations
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
Investigators
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 Submitted: June 27, 2012
First Posted: July 9, 2012
Last Update Posted: July 6, 2017
Last Verified: July 2017

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

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