Development and Testing of a Digitally Assisted Risk Reduction Platform for Youth at High Risk for Suicide
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Columbia Suicide Severity Rating Scale (C-SSRS)
研究概览
简要总结
Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death among youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to provide a unique understanding of risk factors, including psychological distress, anhedonia and behavioral withdrawal, and sleep disturbance among high-risk individuals. This project aims to enhance the effectiveness of the delivery of preventative health care to youth at risk for suicide by developing a comprehensive digital platform that allows practitioners to integrate mobile sensing data and HIPAA-compliant client communication tools into their management of these young people.
详细描述
Suicide is the second leading cause of death among youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to provide a unique understanding of risk factors, including psychological distress, anhedonia and behavioral withdrawal, and sleep disturbance among high-risk individuals. This project aims to enhance the effectiveness of the delivery of preventative health care to youth at risk for suicide by developing a comprehensive digital platform that allows practitioners to integrate mobile sensing data and HIPAA-compliant client communication tools into their management of these young people. Specifically, it will conduct a pragmatic randomized controlled trial (RCT) based at the intensive outpatient services (Intensive Adolescent and Family DBT Program (Columbia Doctors)) to test the impact of using the Vira platform for patients versus treatment as usual control (TAU; i.e., not using Vira). This project will include adolescent patients (n = 200) aged 13-18-years-old randomized to: (a) Vira group (n = 100) and (b) treatment as usual control group (n = 100). Participants will include current patients receiving treatment in the intensive outpatient program, and all treatment decisions will be overseen by practitioners within the program. The overarching goal is to test whether using the Vira platform in the context of an intensive outpatient setting improves clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed assent from adolescents ages 13-17 years old and permission from legal guardians, or consent from adolescents age 18 years old.
- •Receiving treatment at the Intensive Adolescent and Family DBT Pgogram
- •13-18 years old
- •Owns a personal smartphone (Android or iPhone 7+)
- •Fluent in English
排除标准
- •Adolescents who require a higher level of care (i.e., are not admitted to the Intensive Outpatient DBT program)
- •Adolescents who are receiving treatment at the Intensive Adolescent and Family DBT program and have already been assigned a clinician
研究组 & 干预措施
Digitally enhanced treatment supported by the Vira platform
Intensive outpatient DBT supported by the Vira platform. The Vira app is installed on the patient's smartphone. The app passively collects data from phone sensors (i.e., measures of physical activity, sleep patterns, mobility, and language patterns reflecting mood states and cognition) that are indicative of risk-relevant behavioral patterns and psychological states. It also prompts users to answer a daily check in question. Mobile sensing data are processed to provide an automated assessment of the user's functioning. Patients will be asked to use Vira for the duration of their intensive outpatient treatment. Patients' use of the Vira app is supported by practitioners, who can schedule just-in-time reminders (i.e., "nudges") to arrive in the user's phone at scheduled times to support their behavior change plan and DBT treatment. The Vira Platform therefore integrates mobile sensing, self-report assessment, and just-in-time nudges and notifications into the practitioner's workflow.
干预措施: Vira (Behavioral)
Treatment as Usual (TAU)
Intensive outpatient DBT + EARS app (passive data monitoring software)
干预措施: Treatment as Usual (TAU) (Behavioral)
结局指标
主要结局
Columbia Suicide Severity Rating Scale (C-SSRS)
时间窗: 6 months
The C-SSRS is an assessment of suicidal thoughts and behaviors in clinical and research settings. The C-SSRS consists of 16 questions about suicidal thoughts and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). This 5-item subscale ranges from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent).
Scale for Suicidal Ideation (SSI)
时间窗: 6 months
The SSI consists of 19 items that evaluate three dimensions of suicide ideation: active suicidal desire, specific plans for suicide, and passive suicidal desire. Each item is rated on a 3-point scale from 0 to 2. The higher the total score, the greater the severity of suicide ideation.
次要结局
- Mood and Feelings Questionnaire (MFQ)(3 and 6 months)
- Pittsburgh Sleep Quality Index (PSQI)(3 and 6 months)
- Screen for Anxiety Related Emotional Disorders (SCARED)(3 and 6 months)
- Risky Behavior Questionnaire for Adolescents (RBQ-A)(3 and 6 months)
- Anticipatory & Consummatory Interpersonal Pleasure Scale (ACIPS)(3 and 6 months)