Clinical Outcomes in Pediatric Obsessive-Compulsive Disorder

Obsessive-compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01635569
• Other study ID #: H12-01656
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2012
• Est. completion date: June 2027

Study information

• Verified date: May 2023
• Source: University of British Columbia
• Contact: Diana Franco Yamin, MA
• Email: dfrancoy[@]bcchr.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Obsessive-compulsive Disorder

Intervention

Behavioral:
• Group-based family cognitive-behavioural therapy
Baseline and post-12 sessions

Other:
• Waitlist
Baseline and post-12 sessions

Locations

Country	Name	City	State
Canada	BC Children's Hospital Research Institute	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Michael Smith Foundation for Health Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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