Attention Training to Modify Error-related Negativity and Risk for Anxiety in Adolescence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- Change in Anxiety Symptoms
研究概览
简要总结
This is a multi-site study to examine error-related brain activity (i.e., the error-related negativity) and anxiety symptoms in 11 to 14 year-olds (N=600) at two time points separated by two years. The study examines the degree to which error-related negativity can predict anxiety prospectively over two years, and whether a computerized game that alters attention to threat can alter error-related negativity and trajectories of anxiety.
详细描述
Approximately 600 youths between the ages of 11 and 14 and their parents will be assessed. Adolescents will be evaluated at baseline using event-related potentials, self-report, and interview-based measures. The error-related negativity will be evaluated immediately (it takes less than 5 minutes to process and score a single subjects' error-related negativity ), and adolescents with good error-related negativity data (~90%, based on scorable error-related negativity data) will be randomly assigned to either an 8-week (i.e., 16 session) adaptive attention bias modification (N=180) or control condition (N=180) or a waitlist condition (N=180) group. Each session lasts 20 minutes, and participants will be asked to complete two 20-minute sessions per week. Participants will be assessed immediately at post, using the same measures from the baseline assessment. All participants will complete a 2-year follow-up lab visit using the same measures from the baseline assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Research assistants assign participants to condition; the investigator is unaware of the assignment. Participants are unaware of the distinction between ABM and CC, though they would know if they were in the wait list group.
入排标准
- 年龄范围
- 11 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children and parent must speak English well enough to complete the study assessments
排除标准
- •current threat of harm to self or others, bipolar illness, psychosis, thought disorder, pervasive developmental disorder, mental retardation, neurological diseases that impair cognition, or significant head injuries (past 3 months).
结局指标
主要结局
Change in Anxiety Symptoms
时间窗: baseline to 2 year follow-up
Symptoms of Anxiety on the Screen for Child Anxiety Related Emotional Disorders (SCARED)
次要结局
未报告次要终点
研究者
Greg Hajcak
Professor
Florida State University