BAMTECH: Multi-Component Breath Alcohol Intervention

Sponsor
Northeastern University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06124898
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
25
1
1
47
0.5

Study Details

Study Description

Brief Summary

This is the first stage of a three-stage, NIH-funded study to develop and test initially a multi-modal intervention concerning blood/breath alcohol concentration for young adults. The multimodal intervention will be made up of brief telehealth counseling and psychoeducation and use of three mobile technologies to facilitate moderate drinking. In the first stage of the study, we will conduct formative research to obtain input from the study population, test initially the telehealth version of the brief counseling and psychoeducation and to develop a simple, "low tech" approach to coaching participants to use the three mobile technologies in typical drinking situations. Participation will last approximately one month.

Condition or Disease Intervention/Treatment Phase
  • Device: Alcohol-related mobile health technologies
  • Behavioral: Motivational interview and psychoeducation on blood/breath alcohol concentration
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Development and Initial Testing of a Multi-Component Breath Alcohol- Focused Intervention for Young Adults, Stage 1
Actual Study Start Date :
Oct 31, 2023
Anticipated Primary Completion Date :
Oct 1, 2026
Anticipated Study Completion Date :
Oct 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Alcohol-related mobile health technologies and motivational interviewing

A smartphone breathalyzer device and its accompanying app; an app that for estimated blood alcohol content (eBAC) based on sex, weight, number of drinks and time taken to consume drinks; and a self texting procedure where one sends themselves a text message each time they consume an alcoholic drink. The motivational interviewing provides counseling and psychoeducation specialized to each participant's drinking habits.

Device: Alcohol-related mobile health technologies
Participants will be asked to use the three mobile technologies as they choose while drinking for a two-week period.
Other Names:
  • Smartphone breathalyzer, BAC estimator app and self-texting procedure
  • Behavioral: Motivational 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.
    Other Names:
  • M.I.
  • Outcome Measures

    Primary Outcome Measures

    1. Perceived value and likelihood of future use of intervention technology [At the end of the two week intervention period]

      Extent to which participants believe the intervention components have value for them and other young adults, assessed by a modified version of the Systems Usability Scale and a qualitative interview. In this interview, participants will be asked questions such as "what specifically did you like or dislike about the alcohol-related technology?" to measure how much they valued the intervention.

    2. Ease of intervention technology use [At the end of the two week intervention period]

      Extent to which participants believe the intervention components are easy to use, both for them and for other young adults, assessed by a modified version of the Systems Usability Scale and a qualitative interview. In this interview, participants will be asked questions such as "how easy was it for you to use the technology?" to measure how easy they thought the intervention technology was to use.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Be able to read English and complete study evaluations

    • Drink alcohol regularly

    Exclusion Criteria:
    • Act in a manner indicative of probable intoxication due to substances during two study appointments either in person or virtually. Participants may be rescheduled for one such occurrence, however after a second, they will be excluded from this study and offered referrals for alcohol treatment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 EDGE Lab Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Northeastern University
    • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    Investigators

    • Principal Investigator: Robert F Leeman, PhD., Northeastern University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Northeastern University
    ClinicalTrials.gov Identifier:
    NCT06124898
    Other Study ID Numbers:
    • IRB22-11-43
    • R34AA029224-01
    First Posted:
    Nov 9, 2023
    Last Update Posted:
    Nov 9, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 9, 2023