Sustainable Habits for Encouraging Even Teen Sleep (SHEETS): A Digital Intervention to Enhance Sleep and Psychiatric Health in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Change in Sleep Regularity Index (SRI)
研究概览
简要总结
This study will examine the feasibility, acceptability, and effectiveness of two digital sleep interventions in improving sleep regularity and psychiatric health during a critical period of adolescence.
详细描述
This study will be testing two digital sleep health interventions for adolescents. Adolescents in both conditions will receive sleep education-related content. This project also uses an innovative digital platform and wearable sensors to deliver feedback.
The purpose of this research study is to evaluate a 6-week digital sleep intervention to promote healthy sleep patterns. The study will be broken up into two phases: Phase 1: Focus group participation. Participants and their guardian will be asked to participate in a focus group to get their thoughts/opinions on the intervention. Phase 2: Participants and their guardian will be asked to come to 4 different study visits: baseline, post-intervention, 3 month and 6 month follow up. Participants will be asked to complete questionnaires about demographics, psychiatric health, and sleep patterns. The participants will be asked to wear an ActiGraph watch for 24hrs/day for a week for 4 separate weeks, a Garmin for the duration of the 6-week intervention and keep a sleep diary through an online 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
- Single (Participant)
盲法说明
Participants will be randomly assigned to one of two interventions, and will not be told which intervention they are assigned to.
入排标准
- 年龄范围
- 12 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ages 12-14 years
- •parent concern on the routines/consistency subscale of the Pediatric Sleep Practices Questionnaire, indicating poor sleep practices (score of 2) in at least one of the following: bedtime consistency, wake time consistency, and bedtime routines;
- •ability to speak, read and write in English
- •access to internet and smartphone device with capacity to download intervention App (iOS and Android)
- •valid email address
- •ability to follow written and verbal instructions
- •ability and willingness to comply with study procedures.
排除标准
- •diagnosed sleep disorder
- •psychiatric disorder under treatment (medication and/or therapy) or intellectual disability
- •chronic pain condition interfering with sleep
- •substance use disorder
- •use of medication for sleep (prescription or over-the-counter)
- •has a sibling also enrolled/participating in the same study
研究组 & 干预措施
SHEETS Arm 1
Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.
干预措施: Garmin, Pattern Health App (Behavioral)
SHEETS Arm 2
Participants will receive sleep education-related content to support good sleep, like setting schedules.
干预措施: Garmin, Pattern Health App (Behavioral)
结局指标
主要结局
Change in Sleep Regularity Index (SRI)
时间窗: Baseline, 6 weeks, 3 months, 6 months
A measure of sleep regularity collected continuously over 7 days via actigraphy. The Sleep Regularity Index (SRI) ranges from 0-100 and is calculated as the proportion of pairs of time points 24 hours apart that have matching sleep/wake status. Higher scores indicate better sleep regularity.
Feasibility as Measured by Recruitment Percentage
时间窗: 6 months
The number of participants consenting (and assenting) divided by the number who were invited (i.e., passed the telephone prescreen) x 100 to produce a percentage.
Feasibility as Measured by the Number of Participants Who Return for Each Sleep Regularity Assessment
时间窗: 6 weeks, 3 months, 6 months
Acceptability as the Average Adherence Rate
时间窗: 6 weeks
Number of Sessions Completed divided by Total Number of Sessions Offered, multiplied by 100.
次要结局
- Change in Self-Reported Sleep Health(Baseline, 6 weeks, 3 months, 6 months)
- Change in Adolescent Reported Psychiatric Health - Internalizing(Baseline, 6 weeks, 3 months, 6 months)
- Change in Parent Reported Psychiatric Health - Internalizing(Baseline, 6 weeks, 3 months, 6 months)
- Sleep Regularity Index (SRI) as Measured by Garmin(6 weeks)