| NCT ID | NCT06240325 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Sleep |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-12-13 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-12-13 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Jessica C Levenson
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT06240325 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Sleep. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06240325 currently recruiting?
Yes, NCT06240325 is actively recruiting participants. Contact the research team at levensonjc@upmc.edu for enrollment information.
Where is the NCT06240325 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT06240325 clinical trial?
NCT06240325 is sponsored by University of Pittsburgh. The principal investigator is Jessica C Levenson at University of Pittsburgh. The trial plans to enroll 100 participants.