Recruiting

Sleep Promotion Program

Sponsor:

University of Pittsburgh

Code:

NCT06240325

Conditions

Sleep

Sleep Disturbance

Insufficient Sleep

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

SPP

Sleep Psychoeducation

Study Details

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 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

Study ID

NCT06240325

Start date

Dec 13, 2024

Status verified date

Sep, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sleep Promotion Program

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.

active comparator: Sleep Psychoeducation

Participants will receive Sleep Psychoeducation (SPE), a 20-minute discussion with a clinician via telehealth (or in person).

Interventions

SPP

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

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 outcome measure

  • Feasibility of Intervention Measure [ Time Frame: Post-Intervention (~8 weeks) ]
  • Acceptability of Intervention Measure [ Time Frame: Post-Intervention (~8 weeks) ]
  • Intervention Appropriateness Measure [ Time Frame: Post-Intervention (~8 weeks) ]
  • Clinical Global Impressions Scale - Improvement [ Time Frame: Post-Intervention (~8 weeks) ]
  • Patient Health Questionnaire - 9 - M [ Time Frame: Change Screening to Post-Intervention (~10 weeks) ]

Central Contacts and Locations

Central contacts

Jessica C Levenson

412-647-7937levensonjc@upmc.edu

Paige DeGennaro

412-246-5974degennaropl@upmc.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15217

Contacts

Jessica C Levenson

4126477937levensonjc@upmc.edu

Paige DeGennaro

412-246-5974degennaropl@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-09-09.