Obsessive-Compulsive Disorder in ChildrenNCT06102941
Cognitive Control Targets for the Treatment of Obsessive Compulsive Disorder in Young Children
A study of Obsessive-Compulsive Disorder in Children, run by Columbia University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Obsessive-Compulsive Disorder in Children
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Marsh Lab, 646-774-5868, childocdstudy@cumc.columbia.edu
Rachel Marsh, PhD
About this study
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.
Read the detailed 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.
- Being tested
- Cognitive Control Training (CT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Control Training (CT)Device
Also called AKL-T01, Akili
4 weeks of an 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 with individually titrated difficulty to engage cognitive control processes.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training for Obsessive-Compulsive Disorder | Experimental | This is an open-label, one-arm study. Children who meet DSM-V diagnostic criteria for OCD and have clinically significant obsessive-compulsive symptoms (CY-BOCS score>16) will complete 4-weeks of at-home cognitive training. Receives: Device: Cognitive Control Training (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH Toolbox Cognition Battery
Standardized Cognitive Function Composite Scores will be derived from the following NIH Toolbox tasks: 1) Flanker inhibitory control and attention task, 2) Dimensional Change Card Sort (DCCS) test of set-shifting function, 3) List of Working Memory Test, and 4) Pattern Comparison Processing Speed Test.
Measured: Baseline, 2-week follow-up (mid-training), and 4-week follow-up (post-training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start27 Jun 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive Disorder in ChildrenStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Rachel Marsh, Columbia University
- Investigators
- Rachel Marsh, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102941
- Sponsor's protocol ID
- AAAU8631
- Other IDs
- 1R61MH129544-01A1
- Status last verified
- Nov 2025
- First submitted
- 16 Oct 2023
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Control Targets for the Treatment of Obsessive Compulsive Disorder in Young Children
- ClinicalTrials.gov ID
- NCT06102941
- Acronym / sponsor ID
- AAAU8631
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training for Obsessive-Compulsive Disorder | Experimental | Device: Cognitive Control Training (CT)This is an open-label, one-arm study. Children who meet DSM-V diagnostic criteria for OCD and have clinically significant obsessive-compulsive symptoms (CY-BOCS score>16) will complete 4-weeks of at-home cognitive training. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Control Training (CT)Also: AKL-T01, Akili4 weeks of an 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 with individually titrated difficulty to engage cognitive control processes. | Device | Cognitive Training for Obsessive-Compulsive Disorder |
Primary outcome
NIH Toolbox Cognition Battery
Time frame: Baseline, 2-week follow-up (mid-training), and 4-week follow-up (post-training)
Standardized Cognitive Function Composite Scores will be derived from the following NIH Toolbox tasks: 1) Flanker inhibitory control and attention task, 2) Dimensional Change Card Sort (DCCS) test of set-shifting function, 3) List of Working Memory Test, and 4) Pattern Comparison Processing Speed Test.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Obsessive-Compulsive Disorder in Children
Recruiting
Mindfulness Intervention for Psychological and Family Dynamics in Children With Body-Focused Repetitive Behaviors
Mindfulness Skills, Psychosocial Education
Active, not recruiting
Using Personalized Assessments in the Treatment of Childhood OCD
Obsessive-Compulsive Disorder
Recruiting
ICBT for OCD in Children With Autism
Obsessive-Compulsive Disorder, Autism Spectrum Disorder
Active, not recruiting
Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder
Obsessive-Compulsive Disorder in Children, Anxiety Disorder of Childhood
Recruiting
CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD
Cognitive Behavioral Therapy, Obsessive-Compulsive Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Marsh principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Obsessive-Compulsive Disorder in Children, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marsh Lab (646-774-5868, childocdstudy@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIH Toolbox Cognition Battery (time frame: Baseline, 2-week follow-up (mid-training), and 4-week follow-up (post-training)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.