Clinical Outcomes in Pediatric Obsessive-Compulsive Disorder
Primary Purpose
Obsessive-compulsive Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Group-based family cognitive-behavioural therapy
Waitlist
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-compulsive Disorder focused on measuring Obsessive-compulsive disorder, Pediatric, Group-based, Cognitive-behavioural therapy
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
Sites / Locations
- BC Children's Hospital Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
OCD-affected subjects (Group 1)
OCD-affected subjects (Group 2)
Arm Description
OCD-affected subjects will participate in 12 sessions of group therapy (as per GF-CBT protocol).
Waitlist affected-controls awaiting a treatment spot.
Outcomes
Primary Outcome Measures
Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS)
CY-BOCS: gold-standard measure of OCD severity in pediatric OCD.
Secondary Outcome Measures
Full Information
NCT ID
NCT01635569
First Posted
June 27, 2012
Last Updated
May 10, 2023
Sponsor
University of British Columbia
Collaborators
Michael Smith Foundation for Health Research
1. Study Identification
Unique Protocol Identification Number
NCT01635569
Brief Title
Clinical Outcomes in Pediatric Obsessive-Compulsive Disorder
Official Title
Clinical Outcomes Following Group-based Family Cognitive-Behaviour Therapy in Pediatric Obsessive-Compulsive Disorder (OCD)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2012 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Michael Smith Foundation for Health Research
4. Oversight
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-compulsive Disorder
Keywords
Obsessive-compulsive disorder, Pediatric, Group-based, Cognitive-behavioural therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OCD-affected subjects (Group 1)
Arm Type
Active Comparator
Arm Description
OCD-affected subjects will participate in 12 sessions of group therapy (as per GF-CBT protocol).
Arm Title
OCD-affected subjects (Group 2)
Arm Type
Active Comparator
Arm Description
Waitlist affected-controls awaiting a treatment spot.
Intervention Type
Behavioral
Intervention Name(s)
Group-based family cognitive-behavioural therapy
Intervention Description
Baseline and post-12 sessions
Intervention Type
Other
Intervention Name(s)
Waitlist
Intervention Description
Baseline and post-12 sessions
Primary Outcome Measure Information:
Title
Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS)
Description
CY-BOCS: gold-standard measure of OCD severity in pediatric OCD.
Time Frame
Baseline, midpoint, completion of 12 GF-CBT sessions, one-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Franco Yamin, MA
Email
dfrancoy@bcchr.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S. Evelyn Stewart, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Children's Hospital Research Institute
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S. Evelyn Stewart, MD
12. IPD Sharing Statement
Learn more about this trial
Clinical Outcomes in Pediatric Obsessive-Compulsive Disorder
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