Sleep Promotion Program Primary Care

NCT06240325 | Recruiting DMC

• 2 other identifiers: STUDY23010211 (RCT)R34MH132724
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Insufficient Sleep; Sleep; Sleep Disturbance

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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).

  Change Screening to Post-Intervention (~10 weeks)

Secondary Outcomes (6)

• Pediatric Sleep Survey Sleep Knowledge (SK)

  Training Start to End of Study Involvement (Up to 2.5 years)

• SPP Therapy Rating Scale

  Completed at each SPP Session (2 and 4 weeks after baseline)

• Sleep Diary Sleep Duration

  Baseline to Post-Intervention (~8 weeks)

• Sleep Diary Sleep-Wake Regularity

  Baseline to Post-Intervention (~8 weeks)

• Quick Inventory of Depressive Symptoms - Adolescent (17 item) - Self-Report (QIDS-A17-SR)

  Baseline to Post-Intervention (~8 weeks)

Study Arms (2)

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.

Behavioral: SPP

Sleep Psychoeducation

ACTIVE COMPARATOR

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

Behavioral: Sleep Psychoeducation

Interventions

SPP 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.

Sleep Promotion Program

Sleep Psychoeducation BEHAVIORAL

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.

Sleep Psychoeducation

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15217, United States

RECRUITING

MeSH Terms

Conditions

Parasomnias; Sleep Deprivation

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Dyssomnias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jessica C Levenson

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica C Levenson

CONTACT

412-647-7937; levensonjc@upmc.edu

Paige DeGennaro

CONTACT

412-246-5974; degennaropl@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 5, 2024
• Study Start: December 13, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

US (1)