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Sleep Promotion Program Primary Care (SPP PC) Open Trial

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06239792
Acronym
SPP OT
Enrollment
16
Registered
2024-02-02
Start date
2024-05-13
Completion date
2025-05-19
Last updated
2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insufficient Sleep, Sleep, Sleep Disturbance

Brief summary

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.

Interventions

BEHAVIORALSleep Promotion Program

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.

Sponsors

University of Pittsburgh
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJessica C Levenson

University of Pittsburgh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026