Promoting Sleep to Prevent Substance Use in Adolescence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Primary Substance Use
研究概览
简要总结
The goal is to adapt and refine an innovative, developmentally-appropriate universal health promotion intervention to reduce insufficient sleep among adolescents aged 14 to 16, while engaging teens in the adaptation process to maximize the relevance, appeal, and effectiveness of the program for diverse school settings.
详细描述
The goal is to adapt and refine an innovative, developmentally-appropriate universal health promotion intervention to reduce insufficient sleep among adolescents aged 14 to 16, while engaging teens in the adaptation process to maximize the relevance, appeal, and effectiveness of the program for diverse school settings.
The investigators aim to conduct a pilot feasibility randomized controlled trial (RCT) among adolescents (n = 300) who will be randomized to Sleep Fitness (SF) or Sleep Education (SE) to obtain effect size estimates in preparation for a larger scale intervention study. This pilot trial is designed to obtain preliminary data for the following hypotheses:
SF, compared to SE, will produce greater pre-post improvement in sleep after treatment and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources).
SF, compared to SE, will produce greater pre-post reductions in substance use after treatment and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources).
SF, compared to SE, will produce greater pre-post improvement on selected mental health outcomes (anxiety, depression) after treatment and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources).
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)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion and
排除标准
- •are considered at the level of schools, classes, and students.
- •Inclusion Criteria:
- •Schools: Only general education high schools, not "newcomer" schools that target immigrants with limited English ability. Our rationale is that we need students to read and understand English well enough to complete our study measures and understand the intervention.
- •Classes: After the selection of schools, we will select classes that are representative of the school, insofar as they do not reflect Advanced Placement or remedial classes and utilize similar criteria for admission to the classes (e.g. health, advisory) so that we minimize differences between the classes in the study.
- •Students: All participants must receive parental consent, provide their own consent, and must have sufficient English language ability
- •Exclusion Criteria:
- •We propose no exclusion criteria for students who receive parental consent, provide their own assent, and have sufficient English language ability.
研究组 & 干预措施
Sleep Fitness Intervention
The intervention consists of 5-7 sessions on sleep science, the connection between sleep and substance use, behavior change strategies, and motivation to change behavior.
干预措施: Sleep Fitness Intervention (Behavioral)
Psychoeducation (PE)
The control classes will receive an 1-session psycho-educational (PE) intervention that provides information on sleep but does not provide guidance for implementing behavior change and does not explicitly teach about sleep's relationship to substance use.
结局指标
主要结局
Primary Substance Use
时间窗: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)
Measures from Monitoring the Future: 30-day use
Primary Sleep
时间窗: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)
Sleep Diary 1 Week: Total sleep time (Average of weeknights)
次要结局
- Anxiety Symptoms(Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources))
- Depressive Symptoms(Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources))