Comparing Two School-Based Sleep Health Interventions To Promote Sleep Quality in Youth

Part of paid clinical trials in Los Angeles, California.

Sponsor
Children's Hospital Los Angeles
Study ID
NCT07213908
Status
Recruiting
Apply to this trial

Conditions

  • Sleep

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • TS-C-STEP — BEHAVIORAL
    Cognitive behavioral sleep intervention.
  • Sleep Health Education (SHE) — BEHAVIORAL
    Health Education

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
May 2026
Primary completion
Feb 1, 2030
Completion
Jun 1, 2030

Study Design

Enrollment
1,320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Experimental: 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.

Primary Outcome Measure

Change from baseline for total score sleep quality using the Pittsburgh Sleep Quality Index. [ Time Frame: Baseline to 14 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Mariam Adeyeba, PhD
[email protected]
3233569224
Lauren Asarnow, PhD (PRINCIPAL_INVESTIGATOR)
Nationwide Children's HospitalColumbusOhio43205
Jacob Holycross
[email protected]
614.938.0169
Jennifer Hughes, PhD (PRINCIPAL_INVESTIGATOR)

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Children's Hospital Los Angeles· Los Angeles, CANationwide Children's Hospital· Columbus, OH

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