Task Control Circuit Targets for Obsessive Compulsive Behaviors in Children

Not Applicable

Completed

• Conditions: Obsessive-compulsive Disorders and Symptoms in Children
• Interventions: Behavioral: Cognitive Behavioral Therapy; Other: Community Referral as appropriate

• Registration Number: NCT03584945
• Lead Sponsor: University of Michigan

Brief Summary

This study will use magnetic resonance imaging (MRI) to assess the function and structure of overlapping task control circuits in children with a range of Obsessive-Compulsive symptoms (OCS). The functioning of task control circuits will be assessed using the well-validated Multisource interference task (MSIT). This study will also assess functional and anatomical connectivity within task control circuits in the same children, and determine whether disturbances in these overlapping circuits are associated with Obsessive-Compulsive Disorder (OCD) symptom severity. Behavioral measures will be administered to further assess regulatory, learning and memory functions. Children with OCD will then be offered a standard course of up to 12 cognitive behavioral therapy (CBT), either via remote video conference sessions or in person visits when clinically indicated, before scanning (along with age-and gender-matched control participants) in order to assess how these circuits may change with treatment. Children with subclinical OC symptoms will be offered referral for treatment on an as-needed basis. In addition, de-identified data may be used in the future to conduct secondary data analyses. As more about OC symptoms and neurobiological mechanisms of interest in the current study are understood, data may be used to answer questions beyond those described in this protocol. All study procedures will be conducted on-site at Columbia University/the New York State Psychiatric Institute (New York, NY) and the University of Michigan's outpatient Child and Adolescent Psychiatry (Ann Arbor, Michigan).

Detailed Description

Recruitment is complete.

Study Timeline

• Study First Submitted: 2018-06-29
• Study First Submitted QC: 2018-06-29
• Study First Posted: 2018-07-12
• Study Start: 2019-03-24
• Primary Completion: 2023-06-03
• Study Completion: 2023-06-03
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-11
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obsessive Compulsive Disorder	Cognitive Behavioral Therapy	-
Subclinical Obsessive-Compulsive symptoms (OCS)	Community Referral as appropriate	-

Primary Outcome Measures

Name	Time	Method
Blood oxygen-level dependent (BOLD) functional MRI signal during a cognitive conflict task	up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups); approximately 15-20 minutes

Secondary Outcome Measures

Name	Time	Method
Obsessive Compulsive Inventory - Child Version (OCI-CV)	baseline assessment of all participants (OCD, subclinical OCS and HC)	Self-report assessment of obsessive compulsive symptoms, non-clinical to clinical range.
Blood oxygen-level dependent (BOLD) functional connectivity MRI of task control circuits	up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups);approximately 10 minutes
Child Yale-Brown Obsessive Compulsive Scale	up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups);approximately 1 hour	Child Yale-Brown Obsessive Compulsive Scale (CYBOCS) is scored on a scale of 0 to 40, with 40 being the most severe.

Trial Locations

Locations (2)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States