A Sleep Promotion Program for Depressed Adolescents in Pediatric Primary Care Open Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Acceptability of Intervention Measure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 that impact sleep 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.
研究组 & 干预措施
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.
干预措施: Sleep Promotion Program (Behavioral)
结局指标
主要结局
Acceptability of Intervention Measure
时间窗: 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
时间窗: 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.
Clinical Global Impressions Scale - Improvement
时间窗: 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.
Patient Health Questionnaire - 9 - M
时间窗: 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).
Feasibility of Intervention Measure
时间窗: 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.
次要结局
未报告次要终点
研究者
Jessica Levenson
Assistant Professor
University of Pittsburgh