Brain Function and Cognitive Control Training in Children With Obsessive-Compulsive Symptoms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorColumbia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Cognitive Control Training
DeviceDigital, 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Cognitive Training for Subclinical Obsessive-Compulsive SymptomsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
NIH Toolbox Cognition Battery
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.
Time frame
Baseline, post-cognitive training (4 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: