NCT06102941 Cognitive Control Targets for the Treatment of Obsessive Compulsive Disorder in Young Children
| NCT ID | NCT06102941 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Obsessive-Compulsive Disorder in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-06-27 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-06-27 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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;
Contact & Investigator
Rachel Marsh
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT06102941 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 12 Years, studying Obsessive-Compulsive Disorder in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06102941 currently recruiting?
Yes, NCT06102941 is actively recruiting participants. Contact the research team at childocdstudy@cumc.columbia.edu for enrollment information.
Where is the NCT06102941 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06102941 clinical trial?
NCT06102941 is sponsored by Columbia University. The principal investigator is Rachel Marsh at Columbia University. The trial plans to enroll 60 participants.