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
- 1
- 主要终点
- Sleep Diary Sleep Timing
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
- •All participants will be excluded if they live more than roughly an hour's drive from Pittsburgh, Pennsylvania (PA).
- •Insufficient Sleepers:
- •Investigators will screen, deliver universal education (UE), and offer participation to all participants:
- •ages 13 years, 0 months to 15 years, 11 months;
- •able and willing to give informed assent to participate (with informed consent from parent);
- •insufficient sleep (≤7.5 hours sleep on average weeknights); and
- •weekend-weekday sleep timing shift >=1.5 hours.
- •Inclusion criteria are not applicable for parents.
排除标准
- •Evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder will exclude potential participants;
- •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.
- •Sufficient Sleepers:
- •Inclusion Criteria:
- •ages 13-15;
- •sufficient sleep (>7.5 hours of sleep);
- •willing/able to provide informed assent/consent.
- •Exclusion Criteria:
- •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.
研究组 & 干预措施
TAPAS
Participants will participate in the TAPAS intervention, which will consist of one in-person engagement session with a therapist and 8 weeks of web-based automated intervention prompts. The program will utilize empirically supported approaches for promoting sleep health, delivered in-person and via text-message, focusing on: tailored psychoeducation, motivation and efficacy to change sleep, extending sleep duration, and regularizing sleep timing across the week.
干预措施: Targeted Approaches for Promoting Adolescent Sleep (TAPAS) (Behavioral)
Sleep monitoring only, then TAPAS
Participants will participate in sleep monitoring only first, then participate in the TAPAS intervention. First, participants will monitor sleep with sleep diary, but they will not receive feedback or any other information on to sleep.TAPAS will consist of one engagement session with a therapist and 4 weeks of web-based automated intervention prompts. The program will utilize empirically supported approaches for promoting sleep health, delivered in-person and via text-message, focusing on: tailored psychoeducation, motivation and efficacy to change sleep, extending sleep duration, and regularizing sleep timing across the week. Sleep monitoring is proposed to last the same duration as the targeted intervention in this arm.
干预措施: Targeted Approaches for Promoting Adolescent Sleep (TAPAS) (Behavioral)
Sleep monitoring only, then TAPAS
Participants will participate in sleep monitoring only first, then participate in the TAPAS intervention. First, participants will monitor sleep with sleep diary, but they will not receive feedback or any other information on to sleep.TAPAS will consist of one engagement session with a therapist and 4 weeks of web-based automated intervention prompts. The program will utilize empirically supported approaches for promoting sleep health, delivered in-person and via text-message, focusing on: tailored psychoeducation, motivation and efficacy to change sleep, extending sleep duration, and regularizing sleep timing across the week. Sleep monitoring is proposed to last the same duration as the targeted intervention in this arm.
干预措施: Sleep Monitoring Only (Behavioral)
结局指标
主要结局
Sleep Diary Sleep Timing
时间窗: 4 weeks
Average sleep timing as measured by sleep diary
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
次要结局
- Actigraphy Sleep Duration(4 weeks)
- Actigraphy Sleep Timing(4 weeks)
- Actigraphy Weekend-Weekday Sleep Timing Differences(4 weeks)
研究者
Jessica Levenson
Assistant Professor of Psychiatry and Pediatrics
University of Pittsburgh