Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06994962

Multi-Component Breath Alcohol Intervention Phase 3

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
90 (estimated)
Sponsor
Northeastern University · Academic / Other
Sex
All
Age
18 Years – 25 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEAlcohol-related mobile health technologiesParticipants 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 concentrationBrief 25/30-minute motivational interview and psychoeducation on blood/breath alcohol concentration that includes both personalized and standardized information.
BEHAVIORALLower tech facilitationStudy 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 facilitationParticipants 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 EducationBrief 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 TechnologyParticipants will be able to prompt text messages which will provide them one-off trivia facts using information provided during the attention control psychoeducation session

Timeline

Start date
2025-05-01
Primary completion
2026-05-01
Completion
2026-12-31
First posted
2025-05-29
Last updated
2025-06-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06994962. Inclusion in this directory is not an endorsement.