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

Children's Hospital Los Angeles

Status: Not yet enrolling

Conditions: Sleep

Treatments: Behavioral: Sleep Health Education (SHE); Behavioral: TS-C-STEP

Study type: Interventional

Funder types: Other

Identifiers

NCT07213908

SL-2024C1-37532-IC (Other Identifier)

APP-25-03648

Details and patient eligibility

About

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.

Enrollment: 1,320 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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1,320 participants in 2 patient groups

Sleep Health Education (SHE)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Sleep Health Education (SHE)

Transdiagnostic Sleep and Circadian intervention (TS-C-STEP

Experimental group

Description:

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.

Treatment:

Behavioral: TS-C-STEP