CompletedNot Applicable

Sustainable Habits for Encouraging Even Teen Sleep

United States83 participantsStarted 2022-10-21

Plain-language summary

This study will examine the feasibility, acceptability, and effectiveness of two digital sleep interventions in improving sleep regularity and psychiatric health during a critical period of adolescence.

Who can participate

Age range

12 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ages 12-14 years * parent concern on the routines/consistency subscale of the Pediatric Sleep Practices Questionnaire, indicating poor sleep practices (score of 2) in at least one of the following: bedtime consistency, wake time consistency, and bedtime routines; * ability to speak, read and write in English * access to internet and smartphone device with capacity to download intervention App (iOS and Android) * valid email address * ability to follow written and verbal instructions * ability and willingness to comply with study procedures. Exclusion Criteria: * diagnosed sleep disorder * psychiatric disorder under treatment (medication and/or therapy) or intellectual disability * chronic pain condition interfering with sleep * substance use disorder * use of medication for sleep (prescription or over-the-counter) * has a sibling also enrolled/participating in the same study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Sleep Regularity Index (SRI)

Timeframe: Baseline, 6 weeks, 3 months, 6 months

Feasibility as Measured by Recruitment Percentage

Timeframe: 6 months

Feasibility as Measured by the Number of Participants Who Return for Each Sleep Regularity Assessment

Timeframe: 6 weeks, 3 months, 6 months

Acceptability as the Average Adherence Rate

Timeframe: 6 weeks

Trial details

NCT IDNCT05378373

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-31

Results submitted2026-01-28

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