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A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerging Adults

A Feasibility and Acceptability Study of a Large Language Model-based Conversational Agent for Brief Alcohol Intervention Among Emerging Adults

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07214831
Enrollment
20
Registered
2025-10-09
Start date
2027-06-01
Completion date
2028-08-31
Last updated
2025-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALLarge language model-based chatbot brief alcohol intervention session

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.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability - recommend to othersImmediate post-intervention sessionPercentage of participants who agree or strongly agree they would recommend the chatbot to others
Time to achieve target enrollmentEnrollmentRecruitment feasibility will be evaluated based on the length of time needed to recruit target enrollment (N = 20)
Rate of participant retention1-month post intervention1-month post interventionRetention 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)Immediate post-intervention sessionAcceptability 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 methodImmediate post-intervention sessionPercentage of participants who agree or strongly agree the intervention delivery method was acceptable
Acceptability - usableImmediate post-intervention sessionPercentage of participants who agree or strongly agree the intervention was easy to interact with
Acceptability - helpfulImmediate post-intervention sessionPercentage of participants who agree or strongly agree the intervention was helpful

Secondary

MeasureTime frameDescription
Daily drinking questionnaire (DDQ)Enrollment and 1 month post-interventionPast-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.
Alcohol Use Disorders Identification Test (AUDIT)Enrollment and 1 month post-interventionPast-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.
Young Adult Alcohol Consequences Questionnaire (YAACQ)Enrollment and 1 month post-interventionAlcohol-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.
Protective behavioral strategies scale (PBSS)Enrollment and 1 month post-interventionProtective 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).
Alcohol treatment utilizationEnrollment and 1 month post-interventionAlcohol 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.
Motivation to change drinking (Readiness Ruler)Enrollment, immediate post-intervention session, and 1 month post-interventionMotivation to change drinking will measured using the Readiness Ruler.

Countries

United States

Contacts

Primary ContactAlex M Russell, PhD
arussell11@mgh.harvard.edu617-724-0924
Backup ContactSamuel F Acuff, PhD
sacuff@mgh.harvard.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026