Sleep Promotion Program for Teens with Sleep Issues and Depression

This study is testing a new program called the Sleep Promotion Program (SPP) for teenagers aged 12-18 who have trouble sleeping and also have depression. SPP helps teens get more sleep and keep a regular sleep schedule using two individual sessions and smartphone technology. It's being compared to a brief session on healthy sleep habits called Sleep Psychoeducation. Researchers want to see if SPP is practical and effective. Success will be measured by how practical, acceptable, and appropriate the intervention is, all measured around 8 weeks after the program starts. The study is currently unclear about its status and plans to enroll 100 participants.

Study design
This is a pilot randomized controlled trial comparing two behavioral programs. It plans to enroll 100 participants.
What's involved
Participants will have two individual sessions and use smartphone technology. Sleep diary and actigraphy data will be collected.
Compensation
Not stated in the trial record.
Follow-up
Feasibility, acceptability, and appropriateness of the intervention will be measured around 8 weeks after the program.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06240325

Sleep Promotion Program Primary Care

Recruiting
NAAges 12–18InterventionalTreatment
University of Pittsburgh
~100 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:SPPSleep Psychoeducation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of Intervention Measure
Measured over Post-Intervention (~8 weeks)
+4 more outcomes measured
Sleep
Sleep Disturbance
Insufficient Sleep
1 sites across 1 states
Pennsylvania1
  • Jessica C Levenson · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

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Eligibility criteria

Inclusion

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

Exclusion

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.
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.
  • Feasibility of Intervention MeasurePost-Intervention (~8 weeks)

    The Feasibility of Intervention Measure (FIM) is a 4-item measure that assesses the feasibility of the intervention, each item is scored on a 1-5 likert scale (completely disagree to completely agree). Items can be evaluated individually or a scale can be created by averaging responses. Scale values range from 1-5.

  • Acceptability of Intervention MeasurePost-Intervention (~8 weeks)

    The Acceptability of Intervention Measure (AIM) is a 4-item measure that assesses the acceptability of the intervention, each item is scored on a 1-5 likert scale (completely disagree to completely agree). Items can be evaluated individually or a scale can be created by averaging responses. Scale values range from 1-5.

  • Intervention Appropriateness MeasurePost-Intervention (~8 weeks)

    The Intervention Appropriateness Measure (IAM) is a 4-item measure that assesses the appropriateness of the intervention, each item is scored on a 1-5 likert scale (completely disagree to completely agree). Items can be evaluated individually or a scale can be created by averaging responses. Scale values range from 1-5.

  • Clinical Global Impressions Scale - ImprovementPost-Intervention (~8 weeks)

    This is a clinician rating of improvement in sleep and psychopathology. Clinicians rate domains of sleep health, psychiatric symptoms, and overall health on a range from 1 very much improved) to 7 (very much worse). A score of 0 indicates no assessment. Scores for each domain are reported individually.

  • Patient Health Questionnaire - 9 - MChange Screening to Post-Intervention (~10 weeks)

    This is a self-report measure of depressive symptoms. It consists of 9 items rated 0 (not at all) to 3 (nearly every day) over the past 2 weeks. Scores on those 9 items are summed to create a total score (0-27, higher score indicates greater depression).