What this study is
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.
What's being tested
- TS-C-STEP
Intervention · BEHAVIORAL
Cognitive behavioral sleep intervention.
- Sleep Health Education (SHE)
Intervention · BEHAVIORAL
Health Education
Study details
- Sponsor
- Children's Hospital Los Angeles
- Conditions
- Sleep
- Enrolling
- 1,320 people
- Starts
- 2026-03-31
- Est. completion
- 2030-06-01
- Design
- Single-blind, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 12 Years – 18 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openChildren's Hospital Los Angeles
Los Angeles, California, United States
- Mariam Adeyeba, PhD · Contact3233569224madeyeba@chla.usc.edu
- Lauren Asarnow, PhD · Principal investigator
RecruitingNationwide Children's Hospital
Columbus, Ohio, United States
- Jacob Holycross · Contact614.938.0169Jacob.Holycross@nationwidechildrens.org
- Jennifer Hughes, PhD · Principal investigator
Recruiting
Study team
Sponsor
Children's Hospital Los Angeles
Study ID CHLA-25-00326
Principal investigator
Lauren Asarnow,, PhD
Children's Hospital Los Angeles
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.