Recruiting

Cognitive Control

Sponsor:

Columbia University

Code:

NCT06102941

Conditions

Obsessive-Compulsive Disorder in Children

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Not accepted

Interventions

Cognitive Control Training (CT)

Study Details

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

Study ID

NCT06102941

Start date

Jun 27, 2024

Status verified date

Nov, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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;

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Cognitive Control Training (CT)

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.

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 and Locations

Central contacts

Marsh Lab

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

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Marsh Lab

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

Principal Investigator:

Rachel Marsh, PhD

More Information

Sponsor

Columbia University

Last update posted

Nov 6, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2025-11-06.