NCT01635569

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Oct 2012Jun 2027

First Submitted

Initial submission to the registry

June 27, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 9, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
14.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

14.7 years

First QC Date

June 27, 2012

Last Update Submit

May 10, 2023

Conditions

Keywords

Obsessive-compulsive disorderPediatricGroup-basedCognitive-behavioural therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

OCD-affected subjects (Group 1)

ACTIVE COMPARATOR

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

Behavioral: Group-based family cognitive-behavioural therapy

OCD-affected subjects (Group 2)

ACTIVE COMPARATOR

Waitlist affected-controls awaiting a treatment spot.

Other: Waitlist

Interventions

Baseline and post-12 sessions

OCD-affected subjects (Group 1)

Baseline and post-12 sessions

OCD-affected subjects (Group 2)

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Current diagnosis of bipolar disorder, psychosis, mental retardation or pervasive developmental disorder (e.g., autism), and current or past substance dependence/abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Children's Hospital Research Institute

Vancouver, British Columbia, Canada

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • S. Evelyn Stewart, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Franco Yamin, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

June 27, 2012

First Posted

July 9, 2012

Study Start

October 1, 2012

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 12, 2023

Record last verified: 2023-05

Locations