Comparing Two School-Based Sleep Health Interventions To Promote Sleep Quality in Youth
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,320
- 试验地点
- 2
- 主要终点
- Change from baseline for total score sleep quality using the Pittsburgh Sleep Quality Index.
研究概览
简要总结
The goal of this clinical trial is to conduct a comparative effectiveness trial that will evaluate two school-based interventions to improve adolescent sleep health: the standard Sleep Health Education (SHE) and a stepped care version of the Transdiagnostic Sleep and Circadian intervention (TS-C-STEP). The main questions it aims to answer [is/are]:
- TS-C-STEP will yield superior outcomes relative to SHE at post-treatment and up to 12 months following treatment.
- In this large and diverse sample, vulnerable subgroups (e.g. socioeconomically disadvantaged, racial, ethnic, rural, and youth with comorbid learning and/or mental health conditions) will experience greater benefits from TS-C-STEP compared to SHE on primary and secondary outcomes.
Researchers will compare sleep quality to determine which intervention is most effective.
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
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 12-18 years old
- •Sleep health problem (i.e. insomnia, evening circadian preference, short sleep duration, poor sleep quality)
- •Able to participate in a general education classroom.
排除标准
- •Previous participation in the study;
- •Symptoms or illness that precludes informed consent or engagement in study procedures ; youth not fluent in English, parent not fluent in English, or Spanish.
研究组 & 干预措施
Sleep Health Education (SHE)
Participants will be given access to a program, developed for the proposed project, with American Academy of Sleep Medicine (AASM) videos, worksheets and sleep diaries aimed to improve sleep health.
干预措施: Sleep Health Education (SHE) (Behavioral)
Transdiagnostic Sleep and Circadian intervention (TS-C-STEP
In the TS-C-STEP condition, all participants initially are given access to the TS-C program. TS-C is an evidence based cognitive behavioral sleep intervention. Youth will be stepped up to higher levels of care dependent on their progress with the program.
干预措施: TS-C-STEP (Behavioral)
结局指标
主要结局
Change from baseline for total score sleep quality using the Pittsburgh Sleep Quality Index.
时间窗: Baseline to 14 months
A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The sum of scores yields one global score with a minimum score of 0 and a maximum score of 21. A higher score indicates more self-reported sleep problems.
次要结局
- Change from baseline for sleep duration estimates from sleep diaries.(Baseline to 14 months)
- Change from baseline for total insomnia severity score sleep health using the insomnia severity index.(Baseline to 14 months)
- Change from baseline for total evening circadian preference score sleep health using the Children's Morningness and Eveningness Preference.(Baseline to 14 months)
- Change from baseline for total sleep related impairment score sleep health using the PROMIS sleep related impairment questionnaire.(Baseline to 14 months)
- Change from baseline for quality of life and functioning using the PROMIS Global Health Questionnaire.(Baseline to 14 months)
- Change from baseline for academic functioning using official transcripts provided by participants.(Baseline to 14 months)
- Change from baseline for overall mental health using your self-report (youth)(Baseline to 14 months)
- Change from baseline for overall mental health using child-behavior checklist (parent).(Baseline to 14 months)
研究者
Lauren Asarnow
Medical Staff/USC Faculty CWR • Neurology CWR
Children's Hospital Los Angeles