NCT07213908

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,320

participants targeted

Target at P75+ for not_applicable

Timeline
49mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Mar 2026Jun 2030

First Submitted

Initial submission to the registry

September 29, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 9, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2030

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

3.9 years

First QC Date

September 29, 2025

Last Update Submit

February 23, 2026

Conditions

Sleep

Keywords

AdolescentsSleepSchoolsCognitive Behavioral Sleep Intervention

Outcome Measures

Primary Outcomes (1)

  • Change from baseline for total score sleep quality using the Pittsburgh Sleep Quality Index.

    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.

    Baseline to 14 months

Secondary Outcomes (8)

  • 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 sleep duration estimates from sleep diaries.

    Baseline to 14 months

  • Change from baseline for quality of life and functioning using the PROMIS Global Health Questionnaire.

    Baseline to 14 months

  • +3 more secondary outcomes

Study Arms (2)

Sleep Health Education (SHE)

ACTIVE COMPARATOR

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.

Behavioral: Sleep Health Education (SHE)

Transdiagnostic Sleep and Circadian intervention (TS-C-STEP

EXPERIMENTAL

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.

Behavioral: TS-C-STEP

Interventions

TS-C-STEPBEHAVIORAL

Cognitive behavioral sleep intervention.

Transdiagnostic Sleep and Circadian intervention (TS-C-STEP
Sleep Health Education (SHE)BEHAVIORAL

Health Education

Sleep Health Education (SHE)

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You 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 may not qualify 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Study Officials

  • Lauren Asarnow,, PhD

    Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariam Adeyeba, PhD

CONTACT

3233569224madeyeba@chla.usc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Staff/USC Faculty CWR • Neurology CWR

Study Record Dates

First Submitted

September 29, 2025

First Posted

October 9, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

June 1, 2030

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

US(2)