NCT07839013

Brief Summary

The goal of this clinical trial is to learn about brain function and cognition in children ages 8-12 who have subclinical obsessive-compulsive symptoms (OCS), such as unwanted thoughts or repetitive behaviors. The study will also examine whether patterns of brain activity are related to how children respond to cognitive training. The main questions this study aims to answer are:

  • Are there different patterns of brain activity related to cognitive control among children with OCS?
  • Are these patterns related to differences in OCS or cognition?
  • Can brain activity before training help predict changes in cognitive control or OCS severity after cognitive training? Participants will:
  • Complete clinical interviews, questionnaires, and tests of cognition.
  • Have a magnetic resonance imaging scan while completing a cognitive control task.
  • Complete video-game-based cognitive training on an iPad for about 25 minutes a day, 5 days a week, for 4 weeks.
  • Complete another set of clinical interviews and questionnaires after the training.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
45mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 24, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

October 15, 2026

Expected
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

September 24, 2026

Status Verified

September 1, 2026

Enrollment Period

3.7 years

First QC Date

September 18, 2026

Last Update Submit

September 18, 2026

Conditions

Obsessive-Compulsive SymptomsCognitive Control

Outcome Measures

Primary Outcomes (1)

  • NIH Toolbox Cognition Battery

    Standardized Fluid Cognition Composite Score derived from the NIH Toolbox Cognition Battery. Scores are norm-referenced with a mean of 100 and standard deviation of 15; higher scores indicate better cognitive functioning.

    Baseline, post-cognitive training (4 weeks)

Study Arms (1)

Cognitive Training for Subclinical Obsessive-Compulsive Symptoms

EXPERIMENTAL

This is an open-label, one-arm study. Children who have subclinical obsessive-compulsive symptoms (CY-BOCS score 1-12) will complete 4-weeks of at-home cognitive training.

Device: Cognitive Control Training

Interventions

Cognitive Control TrainingDEVICE

Digital, at-home cognitive training program (AKL-T01) delivered on iPad (25 minutes/day, 5 days/week) for 4 weeks. Styled as a child-friendly video game, AKL-T01 cognitive training taps skills like 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 Subclinical Obsessive-Compulsive Symptoms

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 8 to 12 years at the time of consent (i.e., 8.00 - 12.99 years).
  • Will have definite obsession(s) and/or compulsion(s)
  • NO current or lifetime history of meeting DSM-5 criterion B for OCD.
  • Not on psychotropic medication (either treatment-naïve or free of psychotropic medication for at least one month) or on stable medication regime for ADHD (e.g., stimulants).
  • Capacity to provide written informed assent by the participants and permission by the parent/guardian.

You may not qualify if:

  • DSM-5 current major depressive disorder.
  • DSM-5 current or lifetime diagnosis of OCD, PTSD, substance/alcohol abuse, psychotic disorder, bipolar disorder, eating disorder, pervasive developmental disorder.
  • Current or lifetime history of a major medical or neurological problem (e.g., unstable hypertension, seizure disorder, major head trauma).
  • Active suicidal ideation with some intent to act.
  • Presence of metallic device (ferromagnetic implants or dental braces).
  • Females who are pregnant or nursing.
  • Wechsler Abbreviated Scale of Intelligence II Full-scale IQ \<80.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Study Officials

  • Dana Diaz, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Diaz

CONTACT

(646) 774-5128ChildBrainTrain@nyspi.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
Assistant Professor of Medical Psychology (in Psychiatry)

Study Record Dates

First Submitted

September 18, 2026

First Posted

September 24, 2026

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2030

Last Updated

September 24, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)