Sleep Promotion Program Primary Care (SPP PC) Open Trial

NCT06239792 | Completed DMC

• 2 other identifiers: STUDY23010211 (Open)R34MH132724
• Study Type: interventional
• Target: 16
• 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 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.

Conditions

Sleep; Sleep Disturbance; Insufficient Sleep

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)

Study Arms (1)

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: Sleep Promotion Program

Interventions

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.

Also known as: SPP

Sleep Promotion Program

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

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

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15217, United States

Location

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 2, 2024
• Study Start: May 13, 2024
• Primary Completion: May 19, 2025
• Study Completion: May 19, 2025
• Last Updated: November 6, 2025

Record last verified: 2025-11

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)