Feasibility and Preliminary Efficacy of a Digital Mental Health Intervention to Reduce Symptoms of Post-Disaster Traumatic Stress, Depression, and Anxiety in Teens Impacted by Wildfires: A Randomized Multiple-Baseline Single-Case Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Feasibility: intervention safety: number of adverse events
研究概览
简要总结
In October, 2017, Northern California experienced devastating and historic wildfires. Sonoma Rises is an app designed for anyone who was impacted by this event and is intended to help survivors of disaster find their new normal. This study will assess the feasibility and efficacy of a self-help post-disaster mental health intervention delivered via a mobile app with a sample of teens who are experiencing post-disaster mental health symptoms.
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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males & females aged 13-17 years directly impacted by the 2017 wildfires having lost their home or been temporarily displaced
- •Screen positive for PTSD (Child Trauma Screening Questionnaire = 5 or higher)
- •Have regular access to a smart phone and a computer
- •Have a personal email address
- •Speak and read English fluently
- •Have parental consent
排除标准
- •A positive self-reported history of psychosis, bipolar, or schizophrenia
- •Serious self-reported physical health concerns necessitating surgery or with prognosis <6 months
- •A positive screen for a current Substance User Disorder (CRAFFT = 2 or higher)
- •Current self-reported suicidal ideation
- •Self-reported pregnancy
- •Self-reported less than four weeks of stable prescription medication for anxiety, anti-depressant, and sleep promoting medications prior to the screening assessment
结局指标
主要结局
Feasibility: intervention safety: number of adverse events
时间窗: 4 months
safety (i.e., number of adverse events)
Feasibility: intervention promotion
时间窗: 4 months
Net promoter score (i.e., "How likely are you to recommend this to a friend?" score range 0-5; lower score indicates higher likelihood of promotion)
PTSD Symptom Severity
时间窗: 4 months
Child PTSD Symptom Scale for Diagnostic and Statistical Manual-5; score ranges from 0-80; higher scores indicate more PTSD symptom severity
PTSD functional impairment
时间窗: 4 months
Child PTSD Symptom Scale for Diagnostic and Statistical Manual-5; score ranges from 0-7; higher scores indicate more PTSD related functional impairment
Feasibility: intervention satisfaction/acceptability
时间窗: 4 months
satisfaction/acceptability (i.e., participant satisfaction with treatment "how would you rate your overall satisfaction with the program?"- range 0-10 - higher score indicates more satisfaction)
Feasibility: intervention retention: number of treatment completers
时间窗: 4 months
retention (i.e., number of treatment completers)
Feasibility: intervention adherence: number of treatment components completed
时间窗: 4 months
adherence rates (i.e., number of treatment components completed)
Feasibility: engagement rate
时间窗: 4 months
Engagement rate (i.e., Number and average length of logins to the mobile app intervention)
次要结局
- Psychosocial functioning(4 months)
- Internalizing symptoms(4 months)
- Externalizing symptoms(4 months)
研究者
Adrienne Julie Heinz
Research Health Scientist
Stanford University