Program to promote better sleep in adolescents
A Sleep Promotion Program for Depressed Adolescents in Pediatric Primary Care
This study is testing a new sleep program for teens aged 12-18 who struggle with getting enough sleep and feeling down, to see if it helps them sleep better compared to a quick session on healthy sleep habits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06240325 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a behavioral Sleep Promotion Program (SPP) designed for adolescents aged 12-18 who experience short sleep duration and sleep-wake irregularity, alongside depression. The program consists of two individual sessions and utilizes smartphone technology to implement evidence-based strategies. The feasibility and initial effectiveness of the SPP will be tested against a brief session on healthy sleep habits in a pilot randomized controlled trial involving 50 participants. The study aims to provide insights into improving sleep health among youth with specific sleep challenges.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 12-18 who are currently experiencing depression and report insufficient sleep.
Not a fit: Patients with significant medical conditions or specific sleep disorders such as sleep apnea or narcolepsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve sleep duration and overall mental health in adolescents.
How similar studies have performed: Other studies have shown promise in using behavioral interventions to improve sleep in adolescents, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Jessica C Levenson — University of Pittsburgh
- Study coordinator: Jessica C Levenson
- Email: levensonjc@upmc.edu
- Phone: 412-647-7937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.