Brain Function and Cognitive Control Training in Children With Obsessive-Compulsive Symptoms (AKILI - OCS)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Dana Diaz
- Telefonnummer: (646) 774-5128
- E-post: ChildBrainTrain@nyspi.columbia.edu
Studieorter
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New York
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New York, New York, Förenta staterna, 10032
- Columbia University Irving Medical Center
-
Kontakt:
- Dana Diaz
- Telefonnummer: (646) 774-5128
- E-post: ChildBrainTrain@nyspi.columbia.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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).
- Capacity to provide written informed assent by the participants and permission by the parent/guardian.
Exclusion Criteria:
- 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.
- Presence of metallic device (ferromagnetic implants or dental braces).
- Females who are pregnant or nursing.
- Wechsler Abbreviated Scale of Intelligence II Full-scale IQ <80.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Cognitive Training for Subclinical Obsessive-Compulsive Symptoms
This is an open-label, one-arm study. Children who have subclinical obsessive-compulsive symptoms (CY-BOCS score 1-12) will complete 4-weeks of at-home cognitive training. |
Digital, 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
NIH Toolbox Cognition Battery
Tidsram: Baseline, post-cognitive training (4 weeks)
|
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. |
Baseline, post-cognitive training (4 weeks)
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Dana Diaz, PhD, Columbia University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- ACYY1655
- 1K01MH141273-01A1 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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