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OpenTrials
Completed

NCT Number: NCT06239792

Sleep Promotion Program Primary Care (SPP PC) Open Trial

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.

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Key information

Conditions

Sleep Dyssomnias Insufficient Sleep Mental Disorders Nervous System Diseases Neurologic Manifestations Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Deprivation Sleep Disturbance Sleep Wake Disorders

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15217, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 that impact sleep 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.

Treatment and study plan

Sleep Promotion Program

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.

Other names: SPP

Primary outcomes

  1. Feasibility of Intervention Measure

    Time frame: Post-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. Higher score indicates more feasible.

  2. Acceptability of Intervention Measure

    Time frame: Post-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. Higher scores indicate higher acceptability.

  3. Intervention Appropriateness Measure

    Time frame: Post-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. Higher scores indicate higher appropriateness.

  4. Clinical Global Impressions Scale - Improvement

    Time frame: Post-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. Only adolescent responses were used to inform this measure, so it is reflected only for adolescent participants. Data to calculate the sleep health outcome is not available as the measured used to calculate this outcome (Munich Chronotype Questionnaire( was inadvertently omitted from our survey at Post-Intervention). Thus, we cannot report on the sleep health domain, nor the overall health domain as this relies on the sleep health domain. Thus, values reported below reflect only the psychiatric symptoms domain.

  5. Patient Health Questionnaire - 9 - M

    Time frame: Change 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). Only adolescent participants completed this measure.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

A Sleep Promotion Program for Depressed Adolescents in Pediatric Primary Care Open Trial

Acronym: SPP OT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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