Task Control Circuit Targets for Obsessive Compulsive Behaviors in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 169
- Locations
- 3
- Primary Endpoint
- Blood oxygen-level dependent (BOLD) functional MRI signal during a cognitive conflict task
Study Overview
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. U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. This study will resume analysis of results from its two sites for results reporting after OHRP and the IRB has approved the resumption of research.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Blood oxygen-level dependent (BOLD) functional MRI signal during a cognitive conflict task
Time Frame: up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups); approximately 15-20 minutes
Secondary Outcomes
- Obsessive Compulsive Inventory - Child Version (OCI-CV)(baseline assessment of all participants (OCD, subclinical OCS and HC))
- 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)
Investigators
Kate D. Fitzgerald
Professor
Columbia University
