BRITE 2.0: A Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents (ViraSafe RCT (SBIR Phase 2))
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Proximal Engagement
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 amongst youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to increase engagement with effective interventions such as suicide safety planning. The BRITE suicide safety planning app was developed on evidence-based principles and has undergone rigorous formative development and effectiveness evaluations. However, to optimize its functionality, commercial viability, and scale its implementation, issues related to user engagement needed to be addressed. This 3 month Pragmatic Randomized Trial will evaluate the impact of the ViraSafe app-an enhanced version of the BRITE suicide safety planning app-on improving engagement with coping skills and safety planning among suicidal adolescents by comparing its intervention components to those of the original BRITE app.
详细描述
ViraSafe is an augmented version of the BRITE app that integrates the BRITE coping skills and safety planning content into a module within the Vira behavior change platform. Vira, a digital behavior change platform developed by Ksana Health, consists of a smartphone app for patients, along with integrated web portals for practitioners and for healthcare administrators and supervisors. The platform collects self-report and passive data on smartphone usage patterns, such as language use, physical activity, sleep, social interactions, and screen time, and uses these insights to provide objective and continuous measurements of mental health indicators.
Upon downloading the Vira app and accessing the ViraSafe module, participants will complete a safety plan with their provider. Safety plan content will be editable and viewable throughout the intervention for both participants and their providers. Participants will be able to access the safety plan at any time in ViraSafe. Additionally, patients using ViraSafe will be prompted to complete a daily distress rating. ViraSafe uses automated algorithms (i.e., just in time adaptive intervention features) and user input from distress ratings to facilitate increased engagement with coping skills and pushes safety planning materials to users at periods of high risk (i.e., increases in emotional distress).
In addition to the just-in-time reminders (i.e., nudges) pushed automatically by the system, through the Vira Pro platform, practitioners can schedule just-in-time reminders (i.e., "nudges") to arrive in the user's phone to support their behavior change plan.
After undergoing study screening procedures and providing informed consent/assent, participants will complete the baseline assessment (60 minutes) which will occur virtually over video conference software or phone call.
Additional self-reports collected at patient visit will be requested through informed consent process as some overlap with what research team plans to administer. Self-reports will be retrieved for data analysis at the timepoints that align with the study timepoints. Self-reports will be administered by research staff if not available from a clinic's measurement-based care system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The clinical assessor is masked to the intervention
入排标准
- 年龄范围
- 13 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Youth (minors):
- •13-17 years old
- •Suicide attempt in the last year and ideation in the past month
- •English fluency and literacy
- •Parent or legal guardian willing and able to legally provide informed consent
- •Receiving care at one of the study clinical settings with trained providers to onboard ViraSafe or BRITE safety plan
- •Youth (adults)
- •18-24 years old
- •Recent suicide attempt or ideation with a plan
- •English fluency and literacy
- •Receiving care at one of the study clinical settings with trained providers to onboard ViraSafe or BRITE safety plan.
排除标准
- •Youth (minors):
- •Unable to read/understand English
- •Current manic or psychotic episode
- •Development disability precluding comprehension of study procedures
- •No routine access to a mobile phone, assessed by EHR review and during phone screen
- •No eligible parent or legal guardian to provide informed consent
- •Youth (adults):
- •Unable to read/understand English
- •Current manic or psychotic episode
- •Development disability precluding comprehension of study procedures
- •No routine access to a mobile phone, assessed by EHR review and during phone screen
研究组 & 干预措施
ViraSafe
The new augmented app that combines BRITE coping skills and safety planning into the Vira behavior change platform
干预措施: ViraSafe: Treatment pushes (Behavioral)
BRITE
The original BRITE app that promotes self-monitoring and self-management by providing strategies to avoid or cope with triggers for suicidal urges and has been rigorously tested in clinical trials
干预措施: BRITE (Behavioral)
结局指标
主要结局
Proximal Engagement
时间窗: 24 hours
Engagement with the ViraSafe app (i.e., tapping on the push notification, patterns of accessing app features such as coping skills and safety plan) and BRITE app (daily dose rating, post rating after accessing coping skill, editing coping skill content)
Engagement with the apps
时间窗: 3 months
Engagement over the course of the trial will be measured through objective app usage metrics, including total number and frequency of features used.
次要结局
- Technology Acceptance(3 months)
- Suicide Risk Factors: Columbia Suicide Severity Rating Scale (CSSRS)(3 months)
- Suicidal Risk Factors: Reason for Living(3 months)