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NCT Number: NCT07213908

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

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.

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Key information

Conditions

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TS-C-STEP

Behavioral

Cognitive behavioral sleep intervention.

Sleep Health Education (SHE)

Behavioral

Health Education

Primary outcomes

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

    Time frame: 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 outcomes

  1. Change from baseline for total insomnia severity score sleep health using the insomnia severity index.

    Time frame: 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.

  2. Change from baseline for total evening circadian preference score sleep health using the Children's Morningness and Eveningness Preference.

    Time frame: Baseline to 14 months

    Evening Circadian Preference is a reliable and valid 10-item measure of circadian preference among youth

  3. Change from baseline for total sleep related impairment score sleep health using the PROMIS sleep related impairment questionnaire.

    Time frame: 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.

  4. Change from baseline for sleep duration estimates from sleep diaries.

    Time frame: 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.

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

    Time frame: Baseline to 14 months

    The PROMIS Scale Global Health is a ten-item patient reported measure of physical, mental and social health.

  6. Change from baseline for academic functioning using official transcripts provided by participants.

    Time frame: Baseline to 14 months

    Academic Functioning Youth participants will be asked to provider their official academic transcripts.

  7. Change from baseline for overall mental health using your self-report (youth)

    Time frame: 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.

  8. Change from baseline for overall mental health using child-behavior checklist (parent).

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mariam Adeyeba, PhD

CONTACT

[email protected]

3233569224

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Collaborators

  • Nationwide Children's Hospital

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Oct 9, 2025
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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