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NCT Number: NCT06240325

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 adolescents (12-18 years) with short sleep duration, sleep-wake irregularity, and depression.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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 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

SPP

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.

Sleep Psychoeducation

Behavioral

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

  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.

  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.

  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.

  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.

  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).

Secondary outcomes

  1. Pediatric Sleep Survey Sleep Knowledge (SK)

    Time frame: Training Start to End of Study Involvement (Up to 2.5 years)

    This is a provider self-report of knowledge about sleep. The sleep knowledge domain has 21 items that assess provider knowledge or sleep. The response options are true, false, or don't know. The number or percentage of correctly scored items is reported.

  2. SPP Therapy Rating Scale

    Time frame: Completed at each SPP Session (2 and 4 weeks after baseline)

    This is a form completed by an independent rater who will review session recordings and rate them for fidelity. The scale has 5 items rated no (0) or yes (1), and 24 items rated 0 (not discussed/delivered) to 3 (excellent use of the skill). Items can be reported individually or can be summed to obtain a total score. Scale score range is 0 to 77

  3. Sleep Diary Sleep Duration

    Time frame: Baseline to Post-Intervention (~8 weeks)

    This is a youth daily self-report of sleep, from which will be extracted sleep duration, reported in hours and minutes.

  4. Sleep Diary Sleep-Wake Regularity

    Time frame: Baseline to Post-Intervention (~8 weeks)

    This is a youth daily self-report of sleep, from which will be extracted sleep regularity, reported as difference in sleep-wake timing between weekdays and weekends.

  5. Quick Inventory of Depressive Symptoms - Adolescent (17 item) - Self-Report (QIDS-A17-SR)

    Time frame: Baseline to Post-Intervention (~8 weeks)

    This is a secondary measure of youth depression, completed by self-report, with 17 items rated on a 0 to 3 likert scale. The total score is made by summing some of the items with a total score range of 0-27.

  6. Pediatric Sleep Survey PC

    Time frame: Training Start to End of Study Involvement (up to 2.5 years)

    This is a provider self-report of their comfort and capacity delivering the SPP intervention. The comfort and capacity domain asks about provider comfort delivering 14 behavioral sleep strategies, with responses on a likert scale from not at all comfortable to very comfortable. Responses can be reported individually, as well as a percentage of strategies that providers stated they were somewhat or very comfortable providing.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica C Levenson

CONTACT

[email protected]

412-647-7937

Paige DeGennaro

CONTACT

[email protected]

412-246-5974

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

Acronym: SPP PC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2024
Registry last updated
Mar 4, 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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