Clinical Outcomes in Pediatric Obsessive-Compulsive Disorder

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Obsessive-compulsive Disorder

Intervention / Treatment
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* Behavioral: Group-based family cognitive-behavioural therapy
* Other: Waitlist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OCD-affected subjects (Group 1)<br>OCD-affected subjects will participate in 12 sessions of group therapy (as per GF-CBT protocol). | Behavioral: Group-based family cognitive-behavioural therapy<br>* Baseline and post-12 sessions<br>|
| Active Comparator: OCD-affected subjects (Group 2)<br>Waitlist affected-controls awaiting a treatment spot. | Other: Waitlist<br>* Baseline and post-12 sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS) | CY-BOCS: gold-standard measure of OCD severity in pediatric OCD. | Baseline, midpoint, completion of 12 GF-CBT sessions, one-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obsessive-compulsive disorder, Pediatric, Group-based, Cognitive-behavioural therapy