Recruiting

Sleep Promotion Program Primary Care

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…

ClinicalTrials.gov IDNCT06240325

PhaseNA

Enrollment100

SponsorUniversity of Pittsburgh

Age12 Years

SexALL

I'm interested View official listing

Conditions studied

Sleep, Sleep Disturbance, Insufficient Sleep

About this study

Interventions

Behavioral: SPP — 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.
Behavioral: Sleep Psychoeducation — 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.

Primary outcomes

Feasibility of Intervention Measure (Post-Intervention (~8 weeks))
Acceptability of Intervention Measure (Post-Intervention (~8 weeks))
Intervention Appropriateness Measure (Post-Intervention (~8 weeks))
Clinical Global Impressions Scale - Improvement (Post-Intervention (~8 weeks))
Patient Health Questionnaire - 9 - M (Change Screening to Post-Intervention (~10 weeks))

Eligibility information

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.

Study locations

University of Pittsburgh, Pittsburgh, Pennsylvania 15217 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.