RecruitingNot ApplicableNCT06994962

Multi-Component Breath Alcohol Intervention Phase 3

Development and Initial Testing of a Multi-Component Breath Alcohol-Focused Intervention for Young Adults, Stage 3

Sponsor

Northeastern University

Enrollment

90 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Alcohol Drinking Alcohol Use Drinking Behavior

Summary

This is the third stage of a three-stage, NIH-funded study to develop and test a multi-modal intervention concerning blood/breath alcohol concentration for young adults who drink heavily. The multimodal intervention will be made up of brief telehealth counseling and psychoeducation and use of three existing mobile technologies. The brief counseling/psychoeducation and mobile technologies provide personalized feedback regarding blood or breath alcohol content. The long-term goal of use of these mobile technologies will be to facilitate moderate drinking. However, the main goals of the proposed research are to learn more about feasibility of our procedures, perceived value of the technologies and ease of use from the research participants' points of view. In this third stage of the study, the investigators will conduct a randomized controlled trial building on the formative research conducted in Stages 1 and 2.

Eligibility

Min Age: 18 YearsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study tests a multi-component intervention to help young adults who drink heavily moderate their alcohol consumption, combining brief telehealth counseling with three mobile technologies that provide real-time feedback on blood or breath alcohol levels. The overall goal is to understand whether personalized feedback through these tools helps reduce excessive drinking over time. Adults aged 18 to 25 who drink heavily on occasion (4+ drinks for women, 5+ drinks for men) and consume alcohol on at least 12 out of the past 30 days may be eligible, while those with severe substance use disorders, serious psychiatric conditions, or medical conditions worsened by alcohol are excluded. Participation involves using the mobile technologies during drinking occasions, receiving telehealth counseling sessions, and completing assessments about alcohol use and the usefulness of the tools. This summary was generated with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAlcohol-related mobile health technologies

Participants will be asked to use the mobile technologies as they choose while drinking for a four-week period.

BEHAVIORALMotivational interview and psychoeducation on blood/breath alcohol concentration

Brief 25/30-minute motivational interview and psychoeducation on blood/breath alcohol concentration that includes both personalized and standardized information.

BEHAVIORALLower tech facilitation

Study staff will review instructions for technology use closely with participants and guide them in use of existing phone technologies as reminders for use of the three moderate drinking technologies during drinking situations.

BEHAVIORALHigher tech facilitation

Participants will use an app developed during the study, SmartSip, that will provide protective behavioral strategies and reminders for use of the three moderate drinking technologies during drinking situations.

BEHAVIORALAlcohol Education

Brief 25/30-minute psychoeducation on generalized alcohol use providing information about alcohol and its effects, adapted from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Rethinking Drinking resources

DEVICEAlcohol Education Technology

Participants will be able to prompt text messages which will provide them one-off trivia facts using information provided during the attention control psychoeducation session