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| ID | Type | Description | Link |
|---|---|---|---|
| R34AA032472 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Large language model-based chatbot brief alcohol intervention | Experimental | All participants will interact with a large language model-based chatbot designed to deliver a brief alcohol intervention session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Large language model-based chatbot brief alcohol intervention session | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve target enrollment | Recruitment feasibility will be evaluated based on the length of time needed to recruit target enrollment (N = 20) | Enrollment |
| Rate of participant retention | Retention feasibility will be achieved if >80% of participants who consented to participating in the study complete one-month follow-up assessment. | 1-month post intervention1-month post intervention |
| Acceptability (System Usability Scale) | 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. | Immediate post-intervention session |
| Acceptability - intervention delivery method | Percentage of participants who agree or strongly agree the intervention delivery method was acceptable | Immediate post-intervention session |
| Acceptability - usable | Percentage of participants who agree or strongly agree the intervention was easy to interact with | Immediate post-intervention session |
| Acceptability - helpful | Percentage of participants who agree or strongly agree the intervention was helpful | Immediate post-intervention session |
| Acceptability - recommend to others |
| Measure | Description | Time Frame |
|---|---|---|
| Motivation to change drinking (Readiness Ruler) | Motivation to change drinking will measured using the Readiness Ruler. | Enrollment, immediate post-intervention session, and 1 month post-intervention |
| Daily drinking questionnaire (DDQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex M Russell, PhD | Contact | 617-724-0924 | arussell11@mgh.harvard.edu | |
| Samuel F Acuff, PhD | Contact | sacuff@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alex M Russell, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
De-identified data will be submitted to the NIAAA Data Archive in accordance with NIH requirements.
De-identified individual participant data (IPD) and supporting documents will be deposited in the NIAAA Data Archive (NIAAADA) hosted within the NIMH Data Archive. Data will be submitted within 6 months of collection and will be available after study completion, in perpetuity.
Data will be de-identified and available as public use data through the NIAAA Data Archive. Access requires submission of a data use request through the NIAAADA and agreement to the Terms of Use, which limit use to scientific research, prohibit attempts to identify participants, and require reporting of any breaches of confidentiality.
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|
Percentage of participants who agree or strongly agree they would recommend the chatbot to others
| Immediate post-intervention session |
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.
| Enrollment and 1 month post-intervention |
| Alcohol Use Disorders Identification Test (AUDIT) | 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. | Enrollment and 1 month post-intervention |
| Young Adult Alcohol Consequences Questionnaire (YAACQ) | 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. | Enrollment and 1 month post-intervention |
| Protective behavioral strategies scale (PBSS) | 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). | Enrollment and 1 month post-intervention |
| Alcohol treatment utilization | 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. | Enrollment and 1 month post-intervention |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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