A Feasibility and Acceptability Study of a Large Language Model-based Conversational Agent for Brief Alcohol Intervention Among Emerging Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Acceptability (System Usability Scale)
研究概览
简要总结
American emerging adults (EAs; aged 18-29 years) have the highest rates of alcohol use disorder (AUD) and the lowest levels of treatment engagement of any age group. Innovative, scalable, and cost-effective strategies are needed to expand early detection and intervention for EAs engaged in patterns of drinking associated with AUD. Because digital technology use is frequent among EAs, digital interventions may be a particularly suitable way to reach this population. Prior studies of digital alcohol interventions demonstrate modest but consistent reductions in alcohol use, but these tools are often limited by a lack of interactivity and personalization. Large language model (LLM)-based chatbots, such as ChatGPT, may address these limitations by enabling personalized, adaptive, and human-like engagement. These features have the potential to increase uptake and engagement with screening and brief interventions among EAs. This study will develop, validate, and conduct an open trial of an LLM-based chatbot-delivered brief intervention designed to reduce alcohol use and problems among EAs, with the primary goal of establishing preliminary feasibility and acceptability.
详细描述
This feasibility and acceptability study will develop, validate, and conduct a Phase I single-arm open trial of a large language model (LLM)-based chatbot-delivered brief intervention designed to reduce alcohol use and problems among EAs. To develop the augmented LLM, the investigators will use instruction fine-tuning to enhance conversational abilities within the context of brief interventions based on high-fidelity recordings of sessions from prior clinical trials and simulated patient-provider interactions. A retrieval augmented generation system will be developed to ensure the model delivers accurate information. The augmented LLM will be incorporated into a chatbot interface delivered through a user-friendly web application. To validate the chatbot's capability for delivering brief alcohol interventions, patient actors (clinical or counseling psychology PhD students) will be assigned clinical vignettes depicting diverse EAs with patterns of drinking associated with alcohol use disorder. Patient actors will engage in two randomly ordered online text-based brief intervention sessions for each vignette (one with the chatbot and one with a human clinician). Blinded transcripts from sessions will be reviewed by experts to assess treatment fidelity. To maximize and test initial feasibility and acceptability of the intervention, the investigators will conduct semi-structured interviews with 20 EAs who report hazardous drinking, followed by an open trial with another 20 EAs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •18-29 years old
- •Engaged in past-month hazardous drinking (consuming ≥ 5/4 drinks for men/women on two or more occasions in the past month) or exceeded recommended guidelines for risky drinking (> 14/7 drinks per week for men/women)
- •Able to read and comprehend English at a 5th grade level
排除标准
- •Report a history of or active psychosis
- •Previous or current engagement in alcohol or drug treatment
- •Risk for alcohol withdrawal as evidenced by very heavy weekly drinking reports on the alcohol screener (> 40 standard drinks in a typical week in the past month)
- •Demonstrate inability or unwillingness to attend in-person office visits
- •Demonstrate inability or unwillingness to identify an emergency contact who could be contacted in case the participant becomes lost to follow-up
结局指标
主要结局
Acceptability (System Usability Scale)
时间窗: Immediate post-intervention session
Acceptability of the conversational agent-delivered intervention will be measured using the 10-item System Usability Scale. Each question is rated on a Likert-type scale ranging from (1) strongly disagree to (5) strongly agree.
Acceptability - intervention delivery method
时间窗: Immediate post-intervention session
Percentage of participants who agree or strongly agree the intervention delivery method was acceptable
Acceptability - usable
时间窗: Immediate post-intervention session
Percentage of participants who agree or strongly agree the intervention was easy to interact with
Acceptability - helpful
时间窗: Immediate post-intervention session
Percentage of participants who agree or strongly agree the intervention was helpful
Acceptability - recommend to others
时间窗: Immediate post-intervention session
Percentage of participants who agree or strongly agree they would recommend the chatbot to others
Time to achieve target enrollment
时间窗: Enrollment
Recruitment feasibility will be evaluated based on the length of time needed to recruit target enrollment (N = 20)
Rate of participant retention
时间窗: 1-month post intervention1-month post intervention
Retention feasibility will be achieved if \>80% of participants who consented to participating in the study complete one-month follow-up assessment.
Acceptability (System Usability Scale)
时间窗: Immediate post-intervention session
Acceptability of the conversational agent-delivered intervention will be measured using the 10-item System Usability Scale. Each question is rated on a Likert-type scale ranging from (1) strongly disagree to (5) strongly agree.
Acceptability - intervention delivery method
时间窗: Immediate post-intervention session
Percentage of participants who agree or strongly agree the intervention delivery method was acceptable
Acceptability - usable
时间窗: Immediate post-intervention session
Percentage of participants who agree or strongly agree the intervention was easy to interact with
Acceptability - helpful
时间窗: Immediate post-intervention session
Percentage of participants who agree or strongly agree the intervention was helpful
Acceptability - recommend to others
时间窗: Immediate post-intervention session
Percentage of participants who agree or strongly agree they would recommend the chatbot to others
次要结局
- Daily drinking questionnaire (DDQ)(Enrollment and 1 month post-intervention)
- Motivation to change drinking (Readiness Ruler)(Enrollment, immediate post-intervention session, and 1 month post-intervention)
- Alcohol Use Disorders Identification Test (AUDIT)(Enrollment and 1 month post-intervention)
- Young Adult Alcohol Consequences Questionnaire (YAACQ)(Enrollment and 1 month post-intervention)
- Protective behavioral strategies scale (PBSS)(Enrollment and 1 month post-intervention)
- Alcohol treatment utilization(Enrollment and 1 month post-intervention)
- Motivation to change drinking (Readiness Ruler)(Enrollment, immediate post-intervention session, and 1 month post-intervention)
- Daily drinking questionnaire (DDQ)(Enrollment and 1 month post-intervention)
- Alcohol Use Disorders Identification Test (AUDIT)(Enrollment and 1 month post-intervention)
- Young Adult Alcohol Consequences Questionnaire (YAACQ)(Enrollment and 1 month post-intervention)
- Protective behavioral strategies scale (PBSS)(Enrollment and 1 month post-intervention)
- Alcohol treatment utilization(Enrollment and 1 month post-intervention)
研究者
Russell, Alex
Assistant Professor of Psychiatry
Massachusetts General Hospital