Improving Psychological Wellbeing and Decreasing Psychological Distress Among Youth in the Legal System: Multi-Site Feasibility Trial of a Mindfulness Meditation App
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- App adherence (binary)
研究概览
简要总结
This multi-site feasibility clinical trial aims to assess the feasibility of implementing a 1-month app-based meditation program with youth in 4 heterogeneous juvenile legal systems across Oregon and New York. The primary question it is designed to answer is: Will youth adequately adhere to the 1-month meditation app across sites? Secondary feasibility outcomes pertain to recruitment, randomization, retention, and survey completion.
详细描述
The investigators aim to enroll 120 youth (30/site) 13-20 years old who report regular access to an Apple or Android smartphone. Following completion of a baseline survey, participants will be individually randomized at a 1:1 ratio to 1 of 2 smartphone app conditions: (1) Bodhi AIM (Action In Mindfulness), a 30-day meditation app or (2) HIB (Health In Balance), a health promotion control app matched to Bodhi AIM for time and structure. Follow-up assessments will occur at 1 and 6 months. All study activities will be remote.
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
Both participants and outcome assessors will be blind to condition through completion of the baseline assessments. Condition will become apparent to both participants and assessors at the time of app download, but will not be revealed to assessors at any of the follow-up time points until after the quantitative measures are complete.
入排标准
- 年龄范围
- 13 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •13-20 years old
- •In probation or related programming (i.e., in legal programming but not detained) in Oregon or New York State
- •Have access to an Apple/Android smartphone
- •Understand and provide assent/consent
- •Have legal guardian permission (if under 18 years old)
- •English-speaking, due to norming of instruments
排除标准
- •- There are no exclusion criteria.
研究组 & 干预措施
Bodhi AIM
Participants randomized to the intervention arm will receive the Bodhi AIM meditation app.
干预措施: Bodhi AIM (Behavioral)
HIB
Participants randomized to the active control arm will receive the HIB health promotion app.
干预措施: HIB (Behavioral)
结局指标
主要结局
App adherence (binary)
时间窗: 1 month
Percentage of participants who play at least one file on their study app after baseline.
App adherence (continuous)
时间窗: 1 month
Average number of daily app files played over the 1-month intervention period.
次要结局
- Enrollment(Baseline)
- Randomization(Baseline)
- Retention(1 month, 6 months)
- Health questionnaire completion(Baseline, 1 month, 6 months)
- Acceptability of Intervention Measure (AIM)(1 month)
- Intervention Appropriateness Measure (IAM)(1 month)
- Feasibility of Intervention Measure (FIM)(1 month)
研究者
Ashley D Kendall
Principal Investigator
University of Illinois at Chicago