Skip to content

Brain Function and Cognitive Control Training in Children With Obsessive-Compulsive Symptoms

Brain Function and Cognitive Control Training in Children With Obsessive-Compulsive Symptoms

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07839013
Acronym
AKILI - OCS
Enrollment
60
Registered
2026-09-24
Start date
2026-10-15
Completion date
2030-06-30
Last updated
2026-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive-Compulsive Symptoms, Cognitive Control

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.

Interventions

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.

Sponsors

Columbia University
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
NIH Toolbox Cognition BatteryBaseline, post-cognitive training (4 weeks)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.

Countries

United States

Contacts

CONTACTDana Diaz
ChildBrainTrain@nyspi.columbia.edu(646) 774-5128
PRINCIPAL_INVESTIGATORDana Diaz, PhD

Columbia University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 25, 2026