SleepNCT07213908
Comparing Two School-Based Sleep Health Interventions To Promote Sleep Quality in Youth
A study testing TS-C-STEP and Sleep Health Education (SHE) in people with Sleep, run by Children's Hospital Los Angeles at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- TS-C-STEP and Sleep Health Education (SHE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,320 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Mar 2026to 1 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Jacob Holycross, 614.938.0169, Jacob.Holycross@nationwidechildrens.org
Jennifer Hughes, PhD
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Mariam Adeyeba, PhD, 3233569224, madeyeba@chla.usc.edu
Lauren Asarnow, PhD
About this study
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.
- Conditions
- Sleep
- Being tested
- TS-C-STEP, Sleep Health Education (SHE)
- Keywords
- Adolescents, Sleep, Schools, Cognitive Behavioral Sleep Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-C-STEPBehavioural
Cognitive behavioral sleep intervention.
Sleep Health Education (SHE)Behavioural
Health Education
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: TS-C-STEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 14 months
Secondary outcomes (8)
Change from baseline for total insomnia severity score sleep health using the insomnia severity index.
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.
Measured: Baseline to 14 months
Change from baseline for total evening circadian preference score sleep health using the Children's Morningness and Eveningness Preference.
Evening Circadian Preference is a reliable and valid 10-item measure of circadian preference among youth
Measured: Baseline to 14 months
Change from baseline for total sleep related impairment score sleep health using the PROMIS sleep related impairment questionnaire.
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.
Measured: Baseline to 14 months
Change from baseline for sleep duration estimates from sleep diaries.
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.
Measured: Baseline to 14 months
Change from baseline for quality of life and functioning using the PROMIS Global Health Questionnaire.
The PROMIS Scale Global Health is a ten-item patient reported measure of physical, mental and social health.
Measured: Baseline to 14 months
Change from baseline for academic functioning using official transcripts provided by participants.
Academic Functioning Youth participants will be asked to provider their official academic transcripts.
Measured: Baseline to 14 months
Change from baseline for overall mental health using your self-report (youth)
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.
Measured: Baseline to 14 months
Change from baseline for overall mental health using child-behavior checklist (parent).
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.
Measured: Baseline to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start31 Mar 2026
- Primary completion1 Feb 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Responsible party
- Principal investigator, Lauren Asarnow, Children's Hospital Los Angeles
- Investigators
- Lauren Asarnow,, PhD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213908
- Sponsor's protocol ID
- CHLA-25-00326
- Other IDs
- SL-2024C1-37532-IC
- Status last verified
- May 2026
- First submitted
- 29 Sep 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two School-Based Sleep Health Interventions To Promote Sleep Quality in Youth
- ClinicalTrials.gov ID
- NCT07213908
- Acronym / sponsor ID
- CHLA-25-00326
- Conditions
- Sleep
- Keywords
- Adolescents, Sleep, Schools, Cognitive Behavioral Sleep Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,320 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 1 Feb 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Health Education (SHE) | Active comparator | Behavioral: 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. |
| Transdiagnostic Sleep and Circadian intervention (TS-C-STEP | Experimental | Behavioral: TS-C-STEPIn 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TS-C-STEPCognitive behavioral sleep intervention. | Behavioural | Transdiagnostic Sleep and Circadian intervention (TS-C-STEP |
| Sleep Health Education (SHE)Health Education | Behavioural | Sleep Health Education (SHE) |
Primary outcome
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.
8 secondary outcomes
Change from baseline for total insomnia severity score sleep health using the insomnia severity index.
Time frame: Baseline to 14 months
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
Change from baseline for total sleep related impairment score sleep health using the PROMIS sleep related impairment questionnaire.
Time frame: Baseline to 14 months
Change from baseline for sleep duration estimates from sleep diaries.
Time frame: Baseline to 14 months
Change from baseline for quality of life and functioning using the PROMIS Global Health Questionnaire.
Time frame: Baseline to 14 months
Change from baseline for academic functioning using official transcripts provided by participants.
Time frame: Baseline to 14 months
Change from baseline for overall mental health using your self-report (youth)
Time frame: Baseline to 14 months
Change from baseline for overall mental health using child-behavior checklist (parent).
Time frame: Baseline to 14 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauren Asarnow,, PhD principal investigator
Children's Hospital Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TS-C-STEP and Sleep Health Education (SHE) in people with Sleep, run by Children's Hospital Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariam Adeyeba, PhD (3233569224, madeyeba@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline for total score sleep quality using the Pittsburgh Sleep Quality Index. (time frame: Baseline to 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.