Comparing Two School-Based Sleep Health Interventions To Promote Sleep Quality in Youth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TS-C-STEP, Sleep Health Education (SHE).
- Who it may be relevant to
- Registry conditions: Sleep. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral TS-C-STEP
Cognitive behavioral sleep intervention. - Behavioral Sleep Health Education (SHE)
Health Education
Primary outcome measures
- Change from baseline for total score sleep quality using the Pittsburgh Sleep Quality Index. [Time frame: Baseline to 14 months]
Secondary outcome measures (8)
- Change from baseline for total insomnia severity score sleep health using the insomnia severity index. [Time frame: Baseline to 14 months]
- Change from baseline for total evening circadian preference score sleep health using the Children's Morningness and Eveningness Preference. [Time frame: Baseline to 14 months]
- Change from baseline for total sleep related impairment score sleep health using the PROMIS sleep related impairment questionnaire. [Time frame: Baseline to 14 months]
- Change from baseline for sleep duration estimates from sleep diaries. [Time frame: Baseline to 14 months]
- Change from baseline for quality of life and functioning using the PROMIS Global Health Questionnaire. [Time frame: Baseline to 14 months]
- Change from baseline for academic functioning using official transcripts provided by participants. [Time frame: Baseline to 14 months]
- Change from baseline for overall mental health using your self-report (youth) [Time frame: Baseline to 14 months]
- Change from baseline for overall mental health using child-behavior checklist (parent). [Time frame: Baseline to 14 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Children's Hospital Los Angeles — Los Angeles
- Nationwide Children's Hospital — Columbus
Identifiers
NCT: NCT07213908 · CHLA-25-00326 · SL-2024C1-37532-IC