Targeted Intervention for Insufficient Sleep Among Typically-Developing Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Attrition
研究概览
简要总结
The overall aim of Dr. Levenson's research proposal is to test the acceptability, feasibility, and preliminary outcomes of a sleep promotion program delivered to 13-15 year olds who report insufficient sleep. Dr. Levenson will examine the feasibility and acceptability of the program through a randomized pilot trial (n=40) that uses a two-period, wait-list control design. Then, Dr. Levenson will test whether the program is associated with changes in sleep, motivation, and four outcome domains: academic functioning, attention, risk behavior, and affect. Such a broadly relevant program has the potential for enormous public health impact by improving sleep and facilitating healthy development across a range of domains among typically-developing adolescents who are highly vulnerable to adverse consequences.
详细描述
General Description:
This study has two sub-studies: one for youth who experience behaviorally insufficient sleep syndrome (BISS) and one for youth who obtain sufficient sleep. This includes a randomized controlled trial for youth who obtain insufficient sleep (BISS), and a universal education (UE) only intervention for youth who obtain sufficient sleep.
All participants will complete a pre-consent screen. Those with sufficient sleep will complete consent/assent and a full screening assessment, and they will watch a sleep education video (UE). If eligible for the sufficient sleeper study, the full screening assessment will serve as a baseline assessment as well. Participants will complete a follow-up assessment about one month later.
Those who pre-screen as insufficient sleepers will complete consent/assent, complete a full screening process, and watch a sleep education video (UE). Those who remain eligible after the full screening process will complete a baseline assessment. Then, youth will be randomized to the TAPAS intervention or to a wait-list control (monitoring only). After completing the post-period 1 follow-up assessment, those in the wait-list control group will switch to the other arm, via a cross-over design. Participants in the intervention-first group will continue to receive the intervention iin Period 2 after post-period 1. After this period, participants will complete the post-period 2 follow-up assessment.
Detailed Description:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ages 13-15;
- •sufficient sleep (>7.5 hours of sleep);
- •willing/able to provide informed assent/consent.
排除标准
- •Evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder;
- •unstable medical conditions;
- •use of psychotropic medications or medications known to impact sleep;
- •adolescent pregnancy;
- •clinical levels of psychopathology, except for youth with a sole diagnosis of gender dysphoria;
- •current sleep disorders except for sleep-onset insomnia;
- •extreme evening preference; and
- •Currently living >1 hour outside of the greater Pittsburgh region.
结局指标
主要结局
Attrition
时间窗: 4 weeks
Participant attrition rate
Response Rate
时间窗: 4 weeks
Participant response rate to electronic intervention prompts
Adherence
时间窗: 1 session
A locally-developed Sleep Promotion Program Rating form indicates which program components covered in each clinician session. The measure is a checklist that indicates the presence or absence of each component covered in the session.
Participant Satisfaction
时间窗: 4 weeks
A locally-developed Treatment Satisfaction Questionnaire measures program satisfaction. Scores range from 18 to 75, with higher scores indicating greater satisfaction.
Sleep Diary Sleep Duration
时间窗: 4 weeks
Average sleep duration (in hours and minutes) as measured by sleep diary
Sleep Diary Weekend-Weekday Sleep Timing Differences
时间窗: 4 weeks
Difference in average weekend and weekday sleep timing as measured by sleep diary
Sleep Diary Sleep Timing
时间窗: 4 weeks
Average sleep timing as measured by sleep diary
次要结局
- Actigraphy Sleep Timing(4 weeks)
- Actigraphy Weekend-Weekday Sleep Timing Differences(4 weeks)
- Actigraphy Sleep Duration(4 weeks)
研究者
Jessica Levenson
Assistant Professor of Psychiatry and Pediatrics
University of Pittsburgh