Augmented Momentary Personal Ecological Risk Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Acceptability of Intervention Scale (AIM)
研究概览
简要总结
The goal of this intervention study is to co-design and test an Ecological Momentary Assessment (EMA) prototype tool with young adults aged 16-30 experiencing suicidality to see if it is an acceptable and usable clinical tool for risk management.
The main study aims are:
- To co-design a prototype EMA suicide risk monitoring system with patients and health care provider input using Human Centered Design (HCD) methods.
- To test the developed EMA protype with providers and their young adult patients aged 16-30 experiencing suicidality to determine if the EMA prototype is an acceptable and usable clinical tool.
Young adult participants receiving care for active suicidal ideation will
- Download and use the EMA prototype for a total of two months.
- Complete 3 online surveys at 0, 1 and 2 months after enrolled in the study.
详细描述
Death by suicide is a leading cause of preventable mortality for young adults in the United States, yet the health care delivery system is poorly equipped to address this preventable issue. Ecological momentary assessment (EMA) allows patients to easily self-monitor and track symptoms using devices young adults already use (e.g., smartphones) in their natural environments, and can combine self-reported assessment with digital indicators of wellbeing via native smartphone sensors (e.g., daily step counts; number of device unlocks during the night, which may indicate sleep problems). EMA suicide risk detection systems show promise, but acceptability among patients at risk for suicide is unknown, and an actionable system for response to these signals by outpatient health care providers has not been developed.
The current project aims to design (Aim 1) and to examine the acceptability and feasibility of an EMA tool with young adults at risk of suicide in typical outpatient medical settings (Aim 2). Specifically, the goal of this intervention study is to see how EMA based signals of suicide risk can be used in primary health care to support management and care of young adults aged 16-30 experiencing suicidality. We will use human centered design (HCD) to co-develop and test an EMA protype with young adult patients and their health care providers to determine if acceptable and usable clinical tool. The goal of the project is to develop an EMA based prototype that improves management and care for young adults experiencing suicidality and has the potential to be used in other effective risk monitoring strategies to follow.
The specific aims of this proposed study are:
Aim 1: Co-design a prototype EMA suicide risk monitoring system with patients and health care providers through human centered design (HCD).
Aim 1.1 Iteratively co-design an EMA prototype with patient and providers; Aim 1.2 Develop training, and support materials for EMA clinical use. Aim 2: Conduct a feasibility and acceptability pilot of the EMA prototype to inform its revision and further development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Young adults (age 16-30 years)
- •Receiving care at University of Washington Primary Care for suicidal ideation as determined by Electronic Health Record problem list or PHQ-9 suicide risk item >0 in previous year and/or recent (past year) history of suicide attempt and/or active suicidal ideation.
- •Ability to consent to participate
排除标准
- •Age <16 or >30,
- •Non-English speaking
- •No smart phone access
- •Any clinical medical/psychiatric condition, severity of that condition, or life situation that would compromise safe and voluntary study participation.
研究组 & 干预措施
Use of AMPERE EMA prototype
An EMA risk monitoring system using a smartphone EMA app to collect self-reported data from participating patients experiencing suicidal ideation.
干预措施: AMPERE EMA app (Other)
结局指标
主要结局
Acceptability of Intervention Scale (AIM)
时间窗: 2 month post-initiation of AMPERE EMA use
This is a four-item measure of intervention acceptability, where each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. Total mean scores range from 1 - 5, with higher scores indicating higher acceptability. Participants will complete this measure after 4 weeks of using the mobile mental health app to which they are randomized.
Client Satisfaction Questionnaire (CSQ)
时间窗: 2 month post-initiation of AMPERE EMA use
This is a 3 item measure to assess consumer satisfaction with health and human services
System Usability Scale (SUS)
时间窗: 2 month post-initiation of AMPERE EMA use
This is a 10 item measure of system usability with 5 response options. SUS score can range from 0 to 100 with a higher score indicating high usability.
次要结局
- Suicide Related Coping Scale (SRCS)(0, 1, 2 month post-initiation of AMPERE EMA use)
- Helping Alliance Questionnaire (Haq-II)(1, 2 month post-initiation of AMPERE EMA use)
研究者
Ian Bennett
Professor: Psychiatry & Behavioral Sciences
University of Washington