A Sleep Promotion Program for Depressed Adolescents in Pediatric Primary Care
Overview
- Phase
- N/A
- Intervention
- SPP
- Conditions
- Sleep
- Sponsor
- University of Pittsburgh
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Feasibility of Intervention Measure
- Status
- Recruiting
- Last Updated
- last month
Overview
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.
Investigators
Jessica Levenson
Assistant Professor
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •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 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
- •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;
Arms & Interventions
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.
Intervention: SPP
Sleep Psychoeducation
Participants will receive Sleep Psychoeducation (SPE), a 20-minute discussion with a clinician via telehealth (or in person).
Intervention: Sleep Psychoeducation
Outcomes
Primary Outcomes
Feasibility of Intervention Measure
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Sleep Diary Sleep Duration(Baseline to Post-Intervention (~8 weeks))
- Pediatric Sleep Survey PC(Training Start to End of Study Involvement (up to 2.5 years))
- 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-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))