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Clinical Outcomes in Pediatric Obsessive-Compulsive Disorder

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01635569
Enrollment
180
Registered
2012-07-09
Start date
2012-10-01
Completion date
2027-06-30
Last updated
2023-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive-compulsive Disorder

Keywords

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

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).

Interventions

BEHAVIORALGroup-based family cognitive-behavioural therapy

Baseline and post-12 sessions

OTHERWaitlist

Baseline and post-12 sessions

Sponsors

Michael Smith Foundation for Health Research
CollaboratorOTHER
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS)Baseline, midpoint, completion of 12 GF-CBT sessions, one-month follow-upCY-BOCS: gold-standard measure of OCD severity in pediatric OCD.

Countries

Canada

Contacts

Primary ContactDiana Franco Yamin, MA
dfrancoy@bcchr.ca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026