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

Not Applicable

Not yet recruiting

• Conditions: Sleep

• Registration Number: NCT07213908
• Lead Sponsor: Children's Hospital Los Angeles

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-09-29
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-07
• Last Update Submitted: 2025-10-07
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09
• Study Start: 2026-02-01
• Primary Completion: 2030-02-01
• Study Completion: 2030-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1320

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change from baseline for total score sleep quality using the Pittsburgh Sleep Quality Index.	Baseline to 14 months	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline for sleep duration estimates from sleep diaries.	Baseline to 14 months	Sleep diary asks participants about daily morning estimates of sleep the night prior parameters yield a reliable and valid clinical index of self-reported sleep duration.
Change from baseline for total insomnia severity score sleep health using the insomnia severity index.	Baseline to 14 months	7-item scale assessing the perceived severity of insomnia symptoms. The sum of scores yields a total score with a minimum score of 0 and a maximum score of 28. A higher score indicates more severe insomnia symptoms.
Change from baseline for total evening circadian preference score sleep health using the Children's Morningness and Eveningness Preference.	Baseline to 14 months	Evening Circadian Preference is a reliable and valid 10-item measure of circadian preference among youth
Change from baseline for total sleep related impairment score sleep health using the PROMIS sleep related impairment questionnaire.	Baseline to 14 months	PROMIS is a well-validated 8-item measure which assesses self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. A total raw score can range from 8 to 40, with a higher score indicating more sleep related impairment.
Change from baseline for quality of life and functioning using the PROMIS Global Health Questionnaire.	Baseline to 14 months	The PROMIS Scale Global Health is a ten-item patient reported measure of physical, mental and social health.
Change from baseline for academic functioning using official transcripts provided by participants.	Baseline to 14 months	Academic Functioning Youth participants will be asked to provider their official academic transcripts.
Change from baseline for overall mental health using your self-report (youth)	Baseline to 14 months	Youth Self-Report (YSR) is a widely used self-report measure that assesses problem behaviors across multiple domains and provides a summary of total problems which can range from 0 to 224 in raw scores; a higher score indicates more self-reported problems. Raw scores are converted to standardized T-scores, which are adjusted for age and gender and are used to compare a youth's score to a normative sample.
Change from baseline for overall mental health using child-behavior checklist (parent).	Baseline to 14 months	Child Behavior Checklist (CBCL) completed by parents is a widely used child-report measure that assesses problem behaviors across multiple domains and provides a summary of total problems which can range from 0 to 198 in raw scores; a higher score indicates more self-reported problems. Raw scores are converted to standardized T-scores, which are adjusted for age and gender and are used to compare a youth's score to a normative sample.

Trial Locations

Locations (2)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States