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Sleep Promotion Program Primary Care (SPP PC) Open Trial

Sleep Promotion Program Primary Care (SPP PC) Open Trial

Not Recruiting
12-18 years
All
Phase N/A

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Overview

Investigators developed a brief, scalable, behavioral Sleep Promotion Program (SPP) for adolescents with short sleep duration and sleep-wake irregularity, which relies on one individual session and smart phone technology to deliver evidence-based strategies. This open trial portion of the R34 will focus on conducting an open trial (n=8) to iteratively refine provider training, implementation procedures, and SPP program, per participant and staff feedback.

Eligibility

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 details
    Sleep
    Sleep Disturbance
    Insufficient Sleep

NCT06239792

University of Pittsburgh

5 December 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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