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

Last updated: October 31, 2024
Sponsor: Columbia University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obsessive-compulsive Disorder

Anxiety Disorders

Panic Disorders

Treatment

Cognitive Control Training (CT)

Clinical Study ID

NCT06102941
AAAU8631
1R61MH129544-01A1
  • Ages 8-12
  • All Genders

Study 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

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 forAffective Disorders and Schizophrenia for School-Age Children Present and LifetimeVersion (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 ObsessiveCompulsive 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 psychotropicmedication for at least three months) and not receiving current psychotherapy forOCD;

  • Ability to tolerate a treatment-free period (i.e., no treatment other than studyCBT);

  • Capacity to provide informed assent

Exclusion

Exclusion Criteria:

  • Current or past diagnosis of major depressive disorder, PTSD, substance/alcoholabuse, psychotic disorder, bipolar disorder, eating disorder, pervasivedevelopmental disorder, substance/alcohol dependence, or any other Axis I disordernot listed above;

  • Active suicidal ideation;

  • Females who are pregnant or nursing;

  • Any major medical or neurological problem (e.g., unstable hypertension, seizuredisorder, head trauma); -Positive urine screen for illicit drugs;

  • Presence of metallic device or dental braces;

  • IQ <80;

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Cognitive Control Training (CT)
Phase:
Study Start date:
June 27, 2024
Estimated Completion Date:
November 30, 2025

Study Description

Obsessive-Compulsive Disorder (OCD) often onsets in childhood and, if not effectively treated, can lead to lifelong illness and poor functional outcomes. Cognitive behavioral therapy (CBT) with exposure and response prevention (EXRP) is the gold-standard, first-line treatment for children with OCD. However, as many as 40% of pediatric patients treated fail to remit. Based on the extant literature and our preliminary data showing that cognitive control functions are altered in children with OCD, this study is designed to test the hypothesis that cognitive control training (CT) should engage the Cognitive System to prime and augment EXRP response. A 2-year proof of concept study will be conducted to determine if CT enhances cognitive control behavioral performance (target engagement) in 60 children (8-12 years old) with OCD sampled from the general community and affiliated clinics. Children will receive 4 weeks of an at-home computerized cognitive training program (AKL-T01; FDA-approved for pediatric ADHD) 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. Children will complete the NIH Toolbox prior to, mid (2-weeks), and post-CT (4-weeks). Cognitive control behavior will be indexed by NIH Toolbox Cognitive Function Composite. Participants will complete MRI scans pre- and post-CT and then be offered a 12-week course of gold-standard CBT EXRP (or community referrals) after CT. Resting state functional connectivity between task control networks and the Default Mode Network will be explored as a potential mechanism of action.

Connect with a study center

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • New York State Psychiatric Institute

    New York, New York 10032
    United States

    Active - Recruiting

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