Clinical Outcomes in Pediatric Obsessive-Compulsive Disorder

NCT ID: NCT01635569

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-01
• Study Completion Date: 2027-06-30

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).

Conditions

Obsessive-compulsive Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OCD-affected subjects (Group 1)

OCD-affected subjects will participate in 12 sessions of group therapy (as per GF-CBT protocol).

Group Type: ACTIVE_COMPARATOR

Group-based family cognitive-behavioural therapy

Intervention Type: BEHAVIORAL

Baseline and post-12 sessions

OCD-affected subjects (Group 2)

Waitlist affected-controls awaiting a treatment spot.

Group Type: ACTIVE_COMPARATOR

Waitlist

Intervention Type: OTHER

Baseline and post-12 sessions

Interventions

Group-based family cognitive-behavioural therapy

Baseline and post-12 sessions

Intervention Type: BEHAVIORAL

Waitlist

Baseline and post-12 sessions

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michael Smith Foundation for Health Research

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Evelyn Stewart, MD

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

S. Evelyn Stewart, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

BC Children's Hospital Research Institute

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Diana Franco Yamin, MA

Role: CONTACT

dfrancoy@bcchr.ca

Other Identifiers

H12-01656

Identifier Type: -

Identifier Source: org_study_id