Sleep Promotion Program Primary Care
- Conditions
- SleepInsufficient SleepSleep Disturbance
- Interventions
- Behavioral: SPPBehavioral: Sleep Psychoeducation
- Registration Number
- NCT06240325
- Lead Sponsor
- University of Pittsburgh
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
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.
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sleep Promotion Program SPP 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. Sleep Psychoeducation Sleep Psychoeducation Participants will receive Sleep Psychoeducation (SPE), a 20-minute discussion with a clinician via telehealth (or in person).
- Primary Outcome Measures
Name Time Method Feasibility of Intervention Measure Post-Intervention (~8 weeks) 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.
Clinical Global Impressions Scale - Improvement Post-Intervention (~8 weeks) 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.
Acceptability of Intervention Measure Post-Intervention (~8 weeks) 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.
Intervention Appropriateness Measure Post-Intervention (~8 weeks) 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.
Patient Health Questionnaire - 9 - M Change Screening to Post-Intervention (~10 weeks) 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).
- Secondary Outcome Measures
Name Time Method Sleep Diary Sleep Duration Baseline to Post-Intervention (~8 weeks) This is a youth daily self-report of sleep, from which will be extracted sleep duration, reported in hours and minutes.
Pediatric Sleep Survey PC Training Start to End of Study Involvement (up to 2.5 years) This is a provider self-report of their comfort and capacity delivering the SPP intervention. The comfort and capacity domain asks about provider comfort delivering 14 behavioral sleep strategies, with responses on a likert scale from not at all comfortable to very comfortable. Responses can be reported individually, as well as a percentage of strategies that providers stated they were somewhat or very comfortable providing.
Pediatric Sleep Survey Sleep Knowledge (SK) Training Start to End of Study Involvement (Up to 2.5 years) This is a provider self-report of knowledge about sleep. The sleep knowledge domain has 21 items that assess provider knowledge or sleep. The response options are true, false, or don't know. The number or percentage of correctly scored items is reported.
SPP Therapy Rating Scale Completed at each SPP Session (2 and 4 weeks after baseline) This is a form completed by an independent rater who will review session recordings and rate them for fidelity. The scale has 5 items rated no (0) or yes (1), and 24 items rated 0 (not discussed/delivered) to 3 (excellent use of the skill). Items can be reported individually or can be summed to obtain a total score. Scale score range is 0 to 77
Sleep Diary Sleep-Wake Regularity Baseline to Post-Intervention (~8 weeks) This is a youth daily self-report of sleep, from which will be extracted sleep regularity, reported as difference in sleep-wake timing between weekdays and weekends.
Quick Inventory of Depressive Symptoms - Adolescent (17 item) - Self-Report (QIDS-A17-SR) Baseline to Post-Intervention (~8 weeks) This is a secondary measure of youth depression, completed by self-report, with 17 items rated on a 0 to 3 likert scale. The total score is made by summing some of the items with a total score range of 0-27.
Trial Locations
- Locations (1)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States