Multi-Component Breath Alcohol Intervention

Not Applicable

Active, not recruiting

• Conditions: Alcohol Use; Alcohol Drinking; Drinking Behavior
• Interventions: Device: Alcohol-related mobile health technologies; Behavioral: Attention control psychoeducation; Behavioral: Motivational interview and psychoeducation on blood/breath alcohol concentration; Device: Attention control technology; Device: Higher tech facilitation; Behavioral: Lower tech facilitation

• Registration Number: NCT06124898
• Lead Sponsor: Northeastern University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-11-06
• Study Start: 2023-11-09
• Study First Posted: 2023-11-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Moderate drinking technologies with "higher tech" facilitation	Higher tech facilitation	Brief motivational-interviewing-based counseling followed by use of three moderate drinking technologies (breath alcohol device and app, blood alcohol content estimator app and self-texting procedure) with "higher tech" facilitation
Moderate drinking technologies with "lower tech" facilitation	Alcohol-related mobile health technologies	Brief motivational-interviewing-based counseling followed by use of three moderate drinking technologies (breath alcohol device and app, blood alcohol content estimator app and self-texting procedure) with "lower tech" facilitation.
Moderate drinking technologies with "lower tech" facilitation	Lower tech facilitation	Brief motivational-interviewing-based counseling followed by use of three moderate drinking technologies (breath alcohol device and app, blood alcohol content estimator app and self-texting procedure) with "lower tech" facilitation.
Moderate drinking technologies with "higher tech" facilitation	Motivational interview and psychoeducation on blood/breath alcohol concentration	Brief motivational-interviewing-based counseling followed by use of three moderate drinking technologies (breath alcohol device and app, blood alcohol content estimator app and self-texting procedure) with "higher tech" facilitation
Moderate drinking technologies with "lower tech" facilitation	Motivational interview and psychoeducation on blood/breath alcohol concentration	Brief motivational-interviewing-based counseling followed by use of three moderate drinking technologies (breath alcohol device and app, blood alcohol content estimator app and self-texting procedure) with "lower tech" facilitation.
Moderate drinking technologies with "higher tech" facilitation	Alcohol-related mobile health technologies	Brief motivational-interviewing-based counseling followed by use of three moderate drinking technologies (breath alcohol device and app, blood alcohol content estimator app and self-texting procedure) with "higher tech" facilitation
Attention control condition	Attention control technology	To be determined attention control condition, which will involve either non-personalized information about alcohol or feedback regarding another health behavior with minimal relationship to alcohol use, followed by related technology use.
Attention control condition	Attention control psychoeducation	To be determined attention control condition, which will involve either non-personalized information about alcohol or feedback regarding another health behavior with minimal relationship to alcohol use, followed by related technology use.

Primary Outcome Measures

Name	Time	Method
Technology utilization	Across the field testing period, 2-4 weeks	Percentage of reported drinking days on which one reports that moderate drinking technology use has occurred
Usability	At the end of the field testing period, 2-4 weeks	Score on acceptability subscale of Modified System Usability Scale
Acceptability	At the end of the field testing period, 2-4 weeks	Score on acceptability subscale of Modified System Usability Scale

Secondary Outcome Measures

Name	Time	Method
Negative consquences	At the end of the field testing period, 2-4 weeks	Score on the Young Adult Alcohol Consequences Questionnaire
Drinks per drinking day	Across the field testing period, 2-4 weeks	Number of drinks per day during field testing period
Estimated blood alcohol content	Across the field testing period, 2-4 weeks	Average estimated blood alcohol content reached on drinking days

Trial Locations

Locations (1)

EDGE Lab; 🇺🇸 Boston, Massachusetts, United States