Targeting Negative Affect Through Mindfulness Training in Youth at Risk for Internalizing Problems - R61
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Momentary Negative Affect Assessed With Ecological Momentary Assessment
研究概览
简要总结
Randomized controlled trial comparing a coached, app-based mindfulness intervention versus a no-intervention control condition. Primary outcome: adolescents' reports of affect as measured with ecological momentary assessment (EMA) at post-intervention. Participants will include 120 youth ages 12-17 years old.
详细描述
This is a randomized controlled trial testing a 9-session, coached, app-based mindfulness intervention on adolescents' reports of affect as measured with ecological momentary assessment (EMA). Participants will include 120 youth ages 12- to 17-years-old randomized to either the Youth Mindful Awareness Program (YMAP) or to an assessment only control condition. Participation is open to all genders and youth of all races and ethnicities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors of outcomes will be masked to intervention condition
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ages 12- to 17-years-old
- •has access to a smartphone, tablet, or other mobile device on which they can access the mindfulness app and complete EMA reports. Youth without a device will be provided with one for their time in the study.
排除标准
- •current DSM5 diagnosis of an anxiety or depressive disorder with significant clinical impairment
- •current alcohol or substance use disorder; currently suicidal
- •lifetime diagnosis of bipolar disorder, schizophrenia, autism, conduct disorder, or developmental delay
- •reading level below 4th grade
- •not English speaking at a level that would allow them to participate in the intervention and assessments.
结局指标
主要结局
Momentary Negative Affect Assessed With Ecological Momentary Assessment
时间窗: 5 days
Momentary negative affect (mNA) in EMA is the experience of negative emotional states in the moment. Participants complete the Ecological Momentary Assessment (EMA) 4 times a day for 5 days, at random moments across the day (usually once in the morning, once in the early afternoon, once in the late afternoon and once in the evening). The EMA affect measure includes 7 items rated on a 4-point scale; average scores range from 1.00 to 4.00; higher scores indicate more negative affect (NA).
次要结局
未报告次要终点
研究者
Judith Garber
Principal Investigator
Vanderbilt University