An interventional study of SPP and Sleep Psychoeducation in Sleep, Sleep Disturbance and Insufficient Sleep, sponsored by University of Pittsburgh. Recruiting at 1 site in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
Among 146 studies in Sleep Deprivation with a site in United States — 30 open to participants now, 35 under way, none of them phase 3. Sleep Deprivation · United States.
Among the 146 studies in Sleep Deprivation with a site in United States, this one is the 30th largest by planned enrollment of the 127 interventional ones, is one of 12 that started in 2024, is one of 104 with no phase, reaches primary completion later than 13 of the 34 other live ones, and was the 124th registered.
314 studies on the registry are indexed under Sleep Deprivation; 59 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 259 interventional studies indexed under Sleep Deprivation.
Browse Sleep Deprivation studies →30 of the 146 studies in Sleep Deprivation with a site in United States are open now, in 2 countries. Each count lists the studies.
Of the 43 Sleep Deprivation studies recruiting now, 11 (26%) set no upper age limit and 28 (65%) stop at 75 or younger; 5 take children under 18; 29 take healthy volunteers.
This study: 12 Years to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →146 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 12 started in 2024.
Median enrollment 56 across the 127 interventional studies, 64 across the 19 observational. Of the 106 that completed or were terminated, 27 (25%) have results posted.
13 of 146 have an industry lead sponsor. The 10 most frequent:
University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
University of Pittsburgh has 5 studies filed under Sleep Deprivation — fewer than ten, so there is no comparison to draw.
7 of the studies in Sleep Deprivation with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06642246Children's Hospital of PhiladelphiaSleep Promotion and Pediatric Hypertension | 2026-11 |
| NCT06336525Brigham and Women's HospitalAdult Sleep Health in the Rural Appalachia and Mississippi Delta Region and Its Relationships With Cardiometabolic Health Disparities. | 2027-01-31 |
| NCT05393830Beth Israel Deaconess Medical CenterThe Effect of Sleep Loss on Emotion Regulation | 2027-04-01 |
| NCT05703347Children's Hospital of PhiladelphiaOptimizing a Mobile Health Platform for Sleep Promotion and Obesity Prevention in Children | 2027-06 |
| NCT02945501U.S. Army Medical Research and Development CommandTranscranial Electrical Stimulation (TES) at Slow Oscillation (SO) Frequency During NREM Sleep | 2027-06 |
Among the 146 studies in Sleep Deprivation with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Youth:
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:
Parents will be excluded if they:
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.
Behavioral: SPP
Participants will receive Sleep Psychoeducation (SPE), a 20-minute discussion with a clinician via telehealth (or in person).
Behavioral: Sleep Psychoeducation
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Change Screening to Post-Intervention (~10 weeks)
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Training Start to End of Study Involvement (up to 2.5 years)
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: All quantitative data will be cleaned and available for addressing other research questions (those not described in funded/pending grants) within one year of the completion of the study.
Access criteria: Access to data will be provided to those meeting our pre-requesites through the National Database for Clinical Trials (NDCT) Data Access Committee (DAC). Only Investigators and Institutions who have met security measures and have submitted a Data Use Certification co-signed by the PI and the designated Institutional Official at the NIH-recognized sponsoring institution with a current Federal Wide Assurance will be given access. Outside Investigators will be asked to acknowledge the grant that supported the data collection and management in all publications and presentations.
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Oct 2026, 22 months after the start.
Of 141 non-industry interventional studies with no phase under Sleep Deprivation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 44. This study's planned 22 months is above that.
Counting every sponsor, half of 150 studies reached it within 17 months; a quarter within 7 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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