Sleep Promotion Program Primary Care
Recruiting · NCT06240325 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Pittsburgh
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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 it is running
1 location listed across 1 US state.
- University of Pittsburgh - Pittsburgh, Pennsylvania, United States