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

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT06102941
Status
Recruiting

Conditions

  • Obsessive-Compulsive Disorder in Children

Eligibility Criteria

Sex
ALL
Age
8 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Control Training (CT) — DEVICE
    4 weeks of an 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 with individually titrated difficulty to engage cognitive control processes.

Study Details

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.

Key Dates

Start date
Jun 27, 2024
Status verified
Nov 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

NIH Toolbox Cognition Battery [ Time Frame: Baseline, 2-week follow-up (mid-training), and 4-week follow-up (post-training) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Marsh Lab
646-774-5868
Rachel Marsh, PhD (PRINCIPAL_INVESTIGATOR)

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