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

NCT06102941 | Recruiting FDA Device

• 2 other identifiers: AAAU86311R61MH129544-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obsessive-Compulsive Disorder in Children

Outcome Measures

Primary Outcomes (1)

• NIH Toolbox Cognition Battery

  Standardized Cognitive Function Composite Scores will be derived from the following NIH Toolbox tasks: 1) Flanker inhibitory control and attention task, 2) Dimensional Change Card Sort (DCCS) test of set-shifting function, 3) List of Working Memory Test, and 4) Pattern Comparison Processing Speed Test.

  Baseline, 2-week follow-up (mid-training), and 4-week follow-up (post-training)

Study Arms (1)

Cognitive Training for Obsessive-Compulsive Disorder

EXPERIMENTAL

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.

Device: Cognitive Control Training (CT)

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.

Also known as: AKL-T01, Akili

Cognitive Training for Obsessive-Compulsive Disorder

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Current or past diagnosis of major depressive disorder, PTSD, substance/alcohol abuse, psychotic disorder, bipolar disorder, eating disorder, pervasive developmental disorder, substance/alcohol dependence, or any other Axis I disorder not listed above;
• Active suicidal ideation;
• Females who are pregnant or nursing;
• Any major medical or neurological problem (e.g., unstable hypertension, seizure disorder, head trauma); -Positive urine screen for illicit drugs;
• Presence of metallic device or dental braces;
• IQ \<80;

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Study Officials

• Rachel Marsh

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marsh Lab

CONTACT

646-774-5868; childocdstudy@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 26, 2023
• Study Start: June 27, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)