RECRUITING

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

Conditions

Obsessive-Compulsive Disorder in Children

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-27

Study Completion:2025-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06102941

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	* 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;

Inclusion Criteria

Exclusion 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

* 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;

Contacts and Locations

Study Locations (Sites)

Columbia University Irving Medical Center

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-27

Study Completion Date2025-11

Study Record Updates

Study Start Date2024-06-27

Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

Obsessive-Compulsive Disorder in Children