SleepSPP PCNCT06240325
Sleep Promotion Program Primary Care
A study testing SPP and Sleep Psychoeducation in people with Sleep and Sleep Disturbance, run by University of Pittsburgh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Sleep, Sleep Disturbance, Insufficient Sleep
- What is being tested?
- SPP and Sleep Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2024to 30 Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15217
Jessica C Levenson, 4126477937, levensonjc@upmc.edu
Paige DeGennaro, 412-246-5974, degennaropl@upmc.edu
About this study
Official title: A Sleep Promotion Program for Depressed Adolescents in Pediatric 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.
- Conditions
- Sleep, Sleep Disturbance, Insufficient Sleep
- Being tested
- SPP, Sleep Psychoeducation
- Medical subject headings
- Parasomnias, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPPBehavioural
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 PsychoeducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Promotion Program | Experimental | Participants will receive the Sleep Promotion Program (SPP), consisting of 2 individual sessions with a clinician via telehealth (or in-person if desired), about 2 weeks apart, and web-based intervention components. Receives: Behavioral: SPP |
| Sleep Psychoeducation | Active comparator | Participants will receive Sleep Psychoeducation (SPE), a 20-minute discussion with a clinician via telehealth (or in person). Receives: Behavioral: Sleep Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Measure
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.
Measured: Post-Intervention (~8 weeks)
Acceptability of Intervention Measure
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.
Measured: Post-Intervention (~8 weeks)
Intervention Appropriateness Measure
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.
Measured: Post-Intervention (~8 weeks)
Clinical Global Impressions Scale - Improvement
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.
Measured: Post-Intervention (~8 weeks)
Patient Health Questionnaire - 9 - M
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).
Measured: Change Screening to Post-Intervention (~10 weeks)
Secondary outcomes (6)
Pediatric Sleep Survey Sleep Knowledge (SK)
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.
Measured: Training Start to End of Study Involvement (Up to 2.5 years)
SPP Therapy Rating Scale
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
Measured: Completed at each SPP Session (2 and 4 weeks after baseline)
Sleep Diary Sleep Duration
This is a youth daily self-report of sleep, from which will be extracted sleep duration, reported in hours and minutes.
Measured: Baseline to Post-Intervention (~8 weeks)
Sleep Diary Sleep-Wake Regularity
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.
Measured: Baseline to Post-Intervention (~8 weeks)
Quick Inventory of Depressive Symptoms - Adolescent (17 item) - Self-Report (QIDS-A17-SR)
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.
Measured: Baseline to Post-Intervention (~8 weeks)
Pediatric Sleep Survey PC
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.
Measured: Training Start to End of Study Involvement (up to 2.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start13 Dec 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jessica Levenson, University of Pittsburgh
- Investigators
- Jessica C Levenson, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240325
- Sponsor's protocol ID
- STUDY23010211 (RCT)
- Other IDs
- R34MH132724
- Acronym
- SPP PC
- Status last verified
- Sep 2026
- First submitted
- 24 Jan 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with the National Institute of Mental Health (NIMH) Data Archive Data Use Certification, investigators will share data collected as part of this proposal with outside investigators. To access data from this study, outside investigators will be asked to submit a proposal that incudes project aims and hypotheses, variables and analytic approach, and rationale for the proposed analysis. The proposal would also include information on how and where the data will be used, investigators' qualifications, timeframe in which data will be analyzed/submitted/published, source of financial support, and conflict of interest statement. They will be asked to sign a data sharing agreement and confidentiality statement prior to the sharing of this data.