Recruiting

TS-C-STEP vs. SHE

Sponsor:

Children's Hospital Los Angeles

Code:

NCT07213908

Conditions

Sleep

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Accepted

Interventions

TS-C-STEP

Sleep Health Education (SHE)

Study Details

Brief summary:

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.

Conditions

Sleep

Study ID

NCT07213908

Start date

Mar 31, 2026

Status verified date

May, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Feb 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1320 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

TS-C-STEP

Cognitive behavioral sleep intervention.

Sleep Health Education (SHE)

Health Education

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 and Locations

Central contacts

Mariam Adeyeba, PhD

3233569224madeyeba@chla.usc.edu

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Mariam Adeyeba, PhD

3233569224madeyeba@chla.usc.edu

Principal Investigator:

Lauren Asarnow, PhD

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Jacob Holycross

614.938.0169Jacob.Holycross@nationwidechildrens.org

Principal Investigator:

Jennifer Hughes, PhD

More Information

Sponsor

Children's Hospital Los Angeles

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • Adolescents
  • Sleep
  • Schools
  • Cognitive Behavioral Sleep Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital Los Angeles on 2026-05-26.