Sleep Promotion Program Primary Care (NCT06240325) | Clinical Trial Compass
RecruitingNot Applicable
Sleep Promotion Program Primary Care
United States100 participantsStarted 2024-12-13
Plain-language summary
Investigators developed a brief, scalable, behavioral Sleep Promotion Program (SPP) for adolescents with short sleep duration and sleep-wake irregularity, which relies on two individual sessions and smart phone technology to deliver evidence-based strategies. This R34 will test the feasibility and initial effectiveness of the SPP program and provider training via pilot randomized controlled trial (RCT, n=50) comparing SPP to Sleep Psychoeducation, a brief session on healthy sleep habits. Participants will be adolescents (12-18 years) with short sleep duration, sleep-wake irregularity, and depression.
Who can participate
Age range
12 Years – 18 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:
Youth:
* Able and willing to provide informed assent (with consent from parent/guardian)
* Ages 12-18
* Currently a patient at Kids Plus Pediatrics
* Currently depressed
* Report short sleep duration (\<7 hours on school nights) and/or weekday-weekend sleep timing difference of \>=2 hours
Parents:
Parents must be age 18 or older and the parent/guardian of an enrolled youth participant and must have at least 10 hours face-to-face interaction with the youth participant per week.
Exclusion Criteria:
Youth:
* Significant or unstable medical conditions
* Diagnosis of sleep apnea, narcolepsy, restless leg syndrome, nightmare disorder, or periodic limb movement disorder
* Diagnosis of PTSD, bipolar disorder, a psychotic disorder, or substance use disorder
* Currently engaged in cognitive and/or behavioral therapy that aims to improve sleep
* Changes in medications in the month prior to screening
* Active suicidality requiring immediate treatment
* Unable or unwilling to comply with study procedures
* Have any physical or mental condition that would preclude study participation.
Parents will be excluded if they:
* Express active suicidality that requires immediate treatment;
* Have any physical or mental condition that would preclude study participation; OR
* Are unable or unwilling to comply with study procedures.
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
1
Feasibility of Intervention Measure
Timeframe: Post-Intervention (~8 weeks)
2
Acceptability of Intervention Measure
Timeframe: Post-Intervention (~8 weeks)
3
Intervention Appropriateness Measure
Timeframe: Post-Intervention (~8 weeks)
4
Clinical Global Impressions Scale - Improvement
Timeframe: Post-Intervention (~8 weeks)
5
Patient Health Questionnaire - 9 - M
Timeframe: Change Screening to Post-Intervention (~10 weeks)