Cognitive Control Targets for the Treatment of Obsessive Compulsive Disorder in Young Children

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to examine the effects of a game-like program called cognitive control training (CT) for children with obsessive compulsive disorder (OCD). Children enrolled in this study will receive 4 weeks of the at-home computerized cognitive training program (AKL-T01) delivered on iPad (25 minutes/day, 5 days/week). Styled as a child-friendly video game, AKL-T01 CT taps focused attention, response inhibition, and working memory using a series of games to engage cognitive control processes. Children will complete the NIH Toolbox prior to, mid (2-weeks), and post-CT (4-weeks). Participants will complete MRI scans pre- and post-CT and then be offered a 12-week course of gold-standard Cognitive behavioral therapy with exposure and response prevention (or community referrals) after CT. The long-term goal of this study is to test how this CT intervention may enhance cognitive control capacity to reduce symptoms and improve response to cognitive behavioral therapy with exposure and response prevention in children with OCD.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 12
Healthy Volunteers: f
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• Ages between 8 and 12 years;

• Clinically significant OCD as the principal problem. This is defined as follows: they must meet DSM-V criteria for OCD as assessed with the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL). OCD must be the primary source of interference and distress (based on clinical evaluation with K- SADS-PL and Children's Yale-Brown Obsessive Compulsive Scale (C-YBOCS) and they must have clinically significant symptoms (i.e., C-YBOCS) ≥ 16;

• Not on psychotropic medication (either treatment-naïve or free of psychotropic medication for at least three months) and not receiving current psychotherapy for OCD;

• Ability to tolerate a treatment-free period (i.e., no treatment other than study CBT);

• Capacity to provide informed assent

Locations
United States
New York
Columbia University Irving Medical Center
RECRUITING
New York
Time Frame
Start Date: 2024-06-27
Estimated Completion Date: 2025-11
Participants
Target number of participants: 60
Treatments
Experimental: Cognitive Training for Obsessive-Compulsive Disorder
This is an open-label, one-arm study. Children who meet DSM-V diagnostic criteria for OCD and have clinically significant obsessive-compulsive symptoms (CY-BOCS score\>16) will complete 4-weeks of at-home cognitive training.
Related Therapeutic Areas
Sponsors
Leads: Columbia University
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov