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

NCT ID: NCT07213908

Last Updated: 2025-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2030-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Sleep Health Education (SHE)

Intervention Type BEHAVIORAL

Health Education

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.

Group Type EXPERIMENTAL

TS-C-STEP

Intervention Type BEHAVIORAL

Cognitive behavioral sleep intervention.

Interventions

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TS-C-STEP

Cognitive behavioral sleep intervention.

Intervention Type BEHAVIORAL

Sleep Health Education (SHE)

Health Education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role collaborator

Children's Hospital Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Lauren Asarnow

Medical Staff/USC Faculty CWR • Neurology CWR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lauren Asarnow,, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

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Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Central Contacts

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Mariam Adeyeba, PhD

Role: CONTACT

3233569224

Facility Contacts

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Mariam Adeyeba, PhD

Role: primary

3233569224

Jacob Holycross

Role: primary

614.938.0169

Other Identifiers

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SL-2024C1-37532-IC

Identifier Type: OTHER

Identifier Source: secondary_id

APP-25-03648

Identifier Type: -

Identifier Source: org_study_id

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