Leveraging Implementation Science to Develop a Mindfulness-Based Intervention to Reduce Alcohol Misuse and Tobacco Use Among Sexual Violence Survivors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Recruitment and retention of 70% of the sample at 3-month follow-up
研究概览
简要总结
The goal is this pilot randomized trial is to learn if intervention 1 is feasible and acceptable. A secondary aim is to learn if intervention 1 reduces alcohol misuse and tobacco use in sexual assault survivors. The main questions it aims to answer are:
- Is intervention 1 feasible to implement?
- Is intervention 1 an acceptable intervention among the primary population, sexual assault survivors?
- Does intervention 1 reduce alcohol misuse and tobacco use?
Researchers will compare intervention 1 to an attention-placebo control group (e.g., online resources on healthy eating and nutrition).
Participants will:
- take online surveys at baseline, 1 month follow-up, and 3-month follow-up
- answer text-message questions at baseline and post-test
- view and engage in an educational program
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
- None
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-24 years of age
- •currently enrolled as a full-time undergraduate at GSU
- •self-reported lifetime SV victimization
- •self-reported SV victimization in the past 6 months
- •drank alcohol within the last 30 days
- •must own a smartphone
排除标准
- •not applicable
结局指标
主要结局
Recruitment and retention of 70% of the sample at 3-month follow-up
时间窗: 3 month follow-up
Feasibility of the sample is assessed by recruitment and retention of at least 70% participants at 3 month follow-up
Acceptability of the mindfulness-based intervention benchmark of 80% self-reported acceptability
时间窗: immediate post-test
Self-reported assessment of the following domains: quality, usefulness, relevancy, extent to which situations depicted are realistic, extent to which attitudes changed on alcohol and tobacco use, and managing stress. Higher scores indicate higher perceived acceptability of the intervention in the indicated domains (e.g., quality, usefulness, relevancy, extent to which situations depicted are realistic, extent to which attitudes changed on alcohol and tobacco use, and managing stress).
次要结局
- Alcohol misuse assessed by Timeline Follow-Back Measuring Alcohol Consumption(3 month follow-up)
研究者
Anne Marie Schipani-McLaughlin
Assistant Professor
Georgia State University