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临床试验/NCT06595862
NCT06595862已完成不适用

Development and Evaluation of an Avatar-guided Mobile Health Intervention for Emerging Adults With Alcohol Misuse and Suicidality

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年1月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
2
主要终点
Feasibility of research protocols, defined as adherence to the ecological momentary assessment/daily diary protocol

研究概览

简要总结

This study is an open pilot usability trial to test the 1) usability of a newly developed mobile health intervention to help manage suicidal ideation and alcohol use problems and 2) feasibility of research protocols with emerging adults (18-29 year-olds) who present to the emergency department.

详细描述

This study is an open pilot usability trial with emerging adults presenting to the emergency department with binge drinking and suicidal thoughts. The main study aims are to test the usability of a newly developed avatar-guided mobile health intervention and feasibility of 28 days of daily assessments and four follow-ups at 4-, 8-, and 12-weeks after discharge.

Ten emerging adults aged 18-29 years old will be recruited from the emergency department who have suicidal ideation and alcohol use problems. Exclusion criteria are conditions that would preclude research participation (e.g., cognitive disabilities, in police custody; at imminent risk of harming oneself in the emergency department).

All ten participants will be given access to a newly designed avatar-guided digital intervention and text message intervention (EA-Avatar) for 12 weeks in addition to usual emergency department care. Participants will complete measures of alcohol use, suicidal ideation, and alcohol-related cognitions and experiences, as well as service utilization. They will also complete a scale of usability of the avatar intervention and qualitative interviews of the intervention and research protocols.

Based on participant qualitative interviews, a scale of usability of the digital intervention, feedback surveys, recruitment and retention in the study, participant completion of daily diary and ecological assessment surveys, and analysis of mobile intervention usage data, the intervention will be revised, before testing in a larger randomized controlled feasibility trial.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Between 18-29 years old
  • •Past month binge drinking OR score of 6 or greater on the Alcohol Use Disorder Identification Test
  • •Past month active suicidal ideation per clinical chart and confirmed via self-report
  • •Have a personal smartphone device with internet access
  • •Speak, read, and understand English

排除标准

  • •Severe cognitive delay, active psychosis, or heavy intoxication that would interfere with understanding the study
  • •Imminent safety risk requiring a 1:1 observation
  • •In police custody during emergency department visit
  • •Unwilling or not interested in using an avatar-directed intervention in addition to their usual emergency department care

研究组 & 干预措施

EA-Avatar

Experimental

The avatar-guided digital intervention includes monitoring of alcohol use and common triggers suicidal thoughts, skills to manage alcohol use and suicidal thoughts, resources on how to access outpatient care and crisis hotlines for suicidal thoughts, and achievements for milestones. In addition, text messages provide reminders to access the avatar platform to learn or practice skills and provide encouragement. EA-Avatar is given in addition to emergency department care as usual.

干预措施: EA-Avatar (Behavioral)

结局指标

主要结局

Feasibility of research protocols, defined as adherence to the ecological momentary assessment/daily diary protocol

时间窗: 12 weeks

Feasibility will be supported by at least 75% of total EMA and daily diary surveys across 28 days

Usability of the EA-Avatar digital intervention, defined by ratings on the System Usability Scale

时间窗: 12 weeks

If any System Usability Items are less than 3.5 out of 5, those aspects of the digital intervention will be revised in the beta version.

Feasibility of research protocols, defined as follow-up retention

时间窗: 12 weeks

Feasibility will be supported by retention of research participants in at least 80% at each of the four assessments

次要结局

  • Acceptability of EA-Avatar as rated on participant feedback surveys(12 weeks)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lourah Kelly

Assistant Professor

University of Massachusetts, Worcester

研究点 (2)

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