NCT07126613

Brief Summary

This study aims to examine the feasibility and acceptability of a mobile health intervention to reduce alcohol use and related consequences among young adults. Participants will be randomly assigned to either receive access to the mobile health intervention or receive only generic study surveys. Participants will receive text message surveys sent to their personal cellphone for 4 weeks per their assigned trial arm. All participants will receive a post-survey 30 days after their final weekly survey text.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 29, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

August 11, 2025

Last Update Submit

January 20, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Average Satisfaction with the Intervention

    Measured using the following item, "How satisfied are you with your experience using this intervention?" with a 5-point response scale ranging from Not at All Satisfied (1) to Extremely Satisfied (5). A higher score indicates higher satisfaction with the intervention

    Assessed 30 days after the last 4-week survey text.

  • Average Engagement with the Intervention Measured by the DCBI Scale

    Engagement will be assessed via 8 items from the Digital Behavior Change Intervention (DCBI) Scale. The item stem "How strongly did you experience the following?" will be repeated for the following concepts: interest, intrigue, focus, inattention, distraction, enjoyment, annoyance, and pleasure. All items will be scored on a 7 point scale from Not at All (1) to Extremely (7) and an average composite score will be derived for each participant based on responses across the seven items. Scores range from 1-7, where a higher score indicates higher engagement with the intervention.

    Assessed 30 days after the last 4-week survey text.

Secondary Outcomes (3)

  • Number of Drinks Consumed per Drinking Episode

    Four days per week (Thursday-Sunday) for four consecutive weeks (16 total times).

  • Average Drinking Level per Drinking Episode

    Four days per week (Thursday-Sunday) for four consecutive weeks (16 total times).

  • Frequency Score of Alcohol-Related Consequences Measured by BYAACQ

    Assessed 30 days after the last 4-week survey text.

Study Arms (2)

Mobile Health Intervention

EXPERIMENTAL

Participants will receive access to the mobile health intervention. This includes access to an online dashboard which includes a drink counter, ability to track the number of drinks consumed over the course of the study, ability to set drinking-related goals for oneself, and alcohol-related resources. Participants in the intervention will also receive tailored messages during drinking episodes which target contextual factors to reduce alcohol use.

Behavioral: Mobile Health Intervention to Reduce Alcohol Use Among Young Adults

No-contact control

NO INTERVENTION

Participants will receive only morning surveys and the 30-day post-test survey.

Interventions

The mobile just-in-time adaptive intervention consists of 1) a digital participant dashboard and 2) tailored messages delivered to the participant's cellphone addressing the individual and ecological contexts of alcohol use. The web-based intervention dashboard includes: 1) a drink counter for participants to log the number and type of drinks (e.g., beer, wine, mixed drink) they consume in a drinking occasion; 2) a calendar which summarizes the number of days on which a participant has consumed alcohol and the number of drinks consumed over the study period, broken out by drink type; 3) a log where participants can set drinking-related goals and update their progress on those goals; and 4) national and local substance use resources. Participants will receive messages tailored to their drinking situation and ecological context during high-risk drinking times.

Mobile Health Intervention

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-25
  • Experience at least one high-intensity drinking episode in the past 30 days
  • Able to read and write in English
  • Consent to receiving text messages to personal cellphone
  • No current history of substance use treatment in the past 12 months
  • Did not participate in the Aim 2 technical field trial of the intervention

You may not qualify if:

  • Under 18 or over 25
  • Did not experience at least one high-intensity drinking episode in the past 30 days
  • Unable to read and write in English
  • Does not consent to receive text messages to personal cellphone
  • Current or history of substance use treatment in the past 12 months
  • Participated in the Aim 2 technical field trial of the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rosenau Hall

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Melissa J Cox, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 17, 2025

Study Start

September 29, 2025

Primary Completion

January 6, 2026

Study Completion

January 6, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The investigator will post de-identified participant data to the National Institute of Mental Health National Data Archive (NDA).

Time Frame
Data will become available 9/1/2027 and be hosted indefinitely on the NDA repository.
Access Criteria
Individuals who meet the data access eligibility criteria set by the NDA may access the IPD.

Locations