RECRUITING Not applicable ClinicalTrials.gov

Sleep Promotion Program Primary Care

Sponsor: University of Pittsburgh • ClinicalTrials.gov ID: NCT06240325

Registry updated: 2026-09-09

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Description

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.

Interventions

SPP (Behavioral)
SPP prioritizes increasing sleep duration and regularizing sleep-wake timing. The provider and youth review the youth's sleep pattern, based on sleep diary data collected before and during the program and actigraphy data collected at baseline. They discuss benefits to the current sleep pattern, reasons for changing sleep, and they create an action plan. Psychoeducation about healthy sleep is offered via a handout developed by our group. Youth and provider jointly select SPP strategies relevant to the contributors to poor sleep for each youth (e.g., time management, limiting weekend oversleep). In the second session they review progress and adjust the plan. Parents participate for part of each session to learn about their child's sleep and to discuss ways they can support their child to make the planned changes.
Sleep Psychoeducation (Behavioral)
Using the pamphlet also used in SPP, SPE will present sleep hygiene practices commonly included in sleep education programs and endorsed by national health organizations.

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.

Conditions

Sleep Sleep Disturbance Insufficient Sleep

Locations

University of Pittsburgh — Pittsburgh, Pennsylvania, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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