Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT07214831
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.
Trial opening soon.
Get Notified18 year–29 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention is a large language model-based chatbot designed to delivered brief alcohol interventions using motivational interviewing-consistent strategies. The chatbot session will last approximately 45 minutes and will include a decisional balance exercise, feedback on drinking patterns, normative beliefs about drinking, alcohol-related consequences, goal setting, and harm-reduction strategies.
Time frame: Enrollment
Recruitment feasibility will be evaluated based on the length of time needed to recruit target enrollment (N = 20)
Time frame: 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.
Time frame: 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.
Time frame: Immediate post-intervention session
Percentage of participants who agree or strongly agree the intervention delivery method was acceptable
Time frame: Immediate post-intervention session
Percentage of participants who agree or strongly agree the intervention was easy to interact with
Time frame: Immediate post-intervention session
Percentage of participants who agree or strongly agree the intervention was helpful
Time frame: Immediate post-intervention session
Percentage of participants who agree or strongly agree they would recommend the chatbot to others
Time frame: Enrollment, immediate post-intervention session, and 1 month post-intervention
Motivation to change drinking will measured using the Readiness Ruler.
Time frame: Enrollment and 1 month post-intervention
Past-month typical drinks per week and frequency of heavy drinking will be assessed using the DDQ. Respondents are asked to record the number of drinks they consume each day of a typical week over the previous month.
Time frame: Enrollment and 1 month post-intervention
Past-month frequency of heavy drinking will be assessed using the AUDIT, a 10-item screening tool used to identify hazardous and harmful drinking patterns. Total scores range from 0 to 40, with higher scores indicating more hazardous or harmful drinking patterns.
Time frame: Enrollment and 1 month post-intervention
Alcohol-related problems will be assessed using the YAACQ. Respondents will be asked to indicate (yes/no) which of the 48 potential problems they have experienced as a result of their drinking over the previous month.
Time frame: Enrollment and 1 month post-intervention
Protective behavioral strategies will be assessed using the 15-item PBSS. Participants will be asked to indicate how often they used each strategy when drinking alcohol during the previous month. Response options are presented on a 6-point Likert type scale ranging from 1 (never) to 6 (always).
Time frame: Enrollment and 1 month post-intervention
Alcohol treatment utilization, including a variety of options, will be measured by asking respondents to indicate (yes/no) which of the potential options they have utilized.
Contact information is provided by the study sponsor or research team.
Alex M Russell, PhD
CONTACT
Samuel F Acuff, PhD
CONTACT
Massachusetts General Hospital
Other
A Feasibility and Acceptability Study of a Large Language Model-based Conversational Agent for Brief Alcohol Intervention Among Emerging Adults
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06790342
Alcohol Use Disorder, Alcohol-Related Disorders
Nairobi, Kenya
View Trial DetailsNCT07678567
Alcohol Use Disorder, Alcohol-Induced Disorders
Louisville, Kentucky, United States
View Trial DetailsNCT07218354
Alcohol Use Disorder, Alcohol-Related Disorders
Long Beach, California, United States
View Trial DetailsNCT07701928
Alcohol Use Disorder, Alcohol-Related Disorders
Spokane, Washington, United States
View Trial Details