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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH132724 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica C Levenson | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15217 | United States |
In accordance with the National Insitute 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.
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 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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 7, 2026 | May 18, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 7, 2026 | May 18, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D020920 | Dyssomnias |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |