Hybrid Type I Effectiveness-implementation Trial of SilverCloud as a School-based Intervention for Vulnerable Youth
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Change in Patient Health Questionnaire-9 (PHQ-9) Score
研究概览
简要总结
The goal of this study is to test the efficacy and feasibility of a clinician-guided, app-based cognitive behavioral therapy (CBT) program, SilverCloud, as a school-based mental health intervention for vulnerable youth. An open trial of SilverCloud will be conducted to determine preliminary efficacy in this sample and inform program refinements by collecting outcome self-report assessments and conducting interviews on feasibility and acceptability. After the program and its implementation strategy are refined, we will conduct an randomized controlled trial. Adolescents who seek or are referred for mental health services through one of the study sites and screen positive for significant mental health symptoms will be randomized to receive SilverCloud or treatment as usual (TAU). Efficacy will be assessed through outcome self-reports. Feasibility and acceptability feedback will again be collected from participants, SBHC staff, and community members.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in the phase I open trial of this study, an individual must meet all of the following criteria:
- •Enrolled in a high school
- •Score of 10+ on GAD-7 or PHQ-9
- •Speak/read English. The current investigational version of SilverCloud that will be used in this study is only available in English.
- •In order to be eligible to participate in the RCT of this study, an individual must meet all of the following criteria:
- •Enrolled in 9th through 11th grades.
- •Score of 10+ on GAD-7 or PHQ-9
- •Enrolled in one of the study sites
- •Speak/read English. The current investigational version of SilverCloud that will be used in this study is only available in English.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in the phase I open trial of this study:
- •Does not use a smartphone
- •Mental health concerns for which intensive treatment is indicated. Because SilverCloud has not been evaluated in people with serious mental illness, participants who exhibit symptoms of mania or psychosis will be referred to a higher level of care.
- •Current suicidal ideation with intent. Participants who have a suicide plan and intent to act on it will be referred to the SBHC suicide risk protocol and will not be eligible until their suicidal thoughts have abated.
- •An individual who meets any of the following criteria will be excluded from participation in the RCT of this study:
- •Current (within 1 month of enrollment) mental health treatment at one of the study sites
- •Does not use a smartphone
- •Mental health concerns for which intensive treatment is indicated. Because SilverCloud has not been evaluated in people with serious mental illness, participants who exhibit symptoms of mania or psychosis will be referred to a higher level of care.
- •Current suicidal ideation with intent. Participants who have a suicide plan and intent to act on it will be referred for crisis intervention through the site at which they were referred and will not be eligible until their suicidal thoughts have abated.
结局指标
主要结局
Change in Patient Health Questionnaire-9 (PHQ-9) Score
时间窗: Baseline, Week 8
The PHQ-9 is a 9-item questionnaire assessing the degree of depression severity. Items are ranked on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-27; higher scores indicate greater severity of depression.
Change in General Anxiety Disorder-7 (GAD-7) Score
时间窗: Baseline, Week 8
The GAD-7 is a 7-item questionnaire assessing the degree of anxiety severity. Items are ranked on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-21; higher scores indicate greater severity of anxiety.
次要结局
- Change in PROMIS Pediatric Item Bank v1.0 - Sleep Disturbance - Short Form 8a(Baseline, Week 8)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Item Bank v2.0 - Peer Relationships - Short Form 8a Score(Baseline, Week 8)
- Change in School Engagement Scale Score(Baseline, Week 8)
- Change in Revised Children's Anxiety and Depression Scale (RCADS-25) Youth Self-Report Score(Baseline, Week 8)
- Change in PROMIS Pediatric Item Bank v1.0 - Family Relationships - Short Form 8a(Baseline, Week 8)