Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT01635569

Conditions

Obsessive-compulsive Disorder

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

Interventions

Group-based family cognitive-behavioural therapy

Waitlist

Study Details

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.

Conditions

Obsessive-compulsive Disorder

Study ID

NCT01635569

Start date

Oct 1, 2012

Status verified date

May, 2023

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

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-BOCSā‰„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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: OCD-affected subjects (Group 1)

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

active comparator: OCD-affected subjects (Group 2)

Waitlist affected-controls awaiting a treatment spot.

Interventions

Group-based family cognitive-behavioural therapy

Baseline and post-12 sessions

Waitlist

Baseline and post-12 sessions

Primary outcome measure

  • Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS) [ Time Frame: Baseline, midpoint, completion of 12 GF-CBT sessions, one-month follow-up ]

Central Contacts and Locations

Central contacts

Diana Franco Yamin, MA

dfrancoy@bcchr.ca

Locations

BC Children's Hospital Research Institute

Recruiting

Vancouver, British Columbia, Canada

Principal Investigator:

S. Evelyn Stewart, MD

More Information

Sponsor

University of British Columbia

Last update posted

May 12, 2023

Last verified

May, 2023

Keywords

  • Obsessive-compulsive disorder
  • Pediatric
  • Group-based
  • Cognitive-behavioural therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2023-05-12.