Brain Function and Cognitive Control Training in Children With Obsessive-Compulsive Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- NIH Toolbox Cognition Battery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Cognitive Control Training (Device)
结局指标
主要结局
NIH Toolbox Cognition Battery
时间窗: 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.
次要结局
未报告次要终点
研究者
Dana Diaz
Assistant Professor of Medical Psychology (in Psychiatry)
Columbia University