CARES: A Mobile Health Program for Alcohol Risk Reduction

Not Applicable

Completed

• Conditions: Alcohol Abuse

• Registration Number: NCT03927482
• Lead Sponsor: The Miriam Hospital

Brief Summary

In this fast-track STTR, Phase 1 will develop and test a mobile phone app among 40 adult community college students. The app is designed to reduce risky drinking behaviors and improve user safety. In Phase 2 the app ("CARES") will be tested with 200 adult community college students who drink alcohol. Participants will be randomly assigned to the "CARES" app or an alcohol education control condition and will use the app for 12 weeks. Six month outcomes will assess changes in drinking related behaviors.

Detailed Description

This STTR builds on our successful pilot that developed a text message-delivered alcohol intervention for, and in collaboration with CCS. Phase I will develop and test a smart phone application (the "Cares" app) incorporating the text message program with additional features and functionality requested by students in the pilot trial (Aim 1.1). After obtaining user feedback (Aim 1.2) programming will be completed in both iOS and Android languages. To ensure that the College Alcohol Risk Education System (CARES) is well positioned to get into the community college marketplace, it is critical to demonstrate efficacy. Phase 2 will conduct an efficacy trial of CARES compared to a competing alcohol education program that would be feasible for most community colleges to adopt, thus providing a real-world comparison with data suitable to support future efforts toward commercialization. This study will also identify the types of individuals for whom CARES is more/less effective and identify how it might be improved.

Study Timeline

• Study Start: 2018-08-02
• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-25
• Primary Completion: 2021-09-15
• Study Completion: 2022-01-31
• Results First Submitted: 2022-08-08
• Results First Submitted QC: 2022-08-08
• Results First Posted: 2022-08-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

Inclusion Criteria

• Currently enrolled community college student
• At least 2 heavy drinking episodes in past 2 weeks at recruitment
• Own smart phone

Exclusion Criteria

• Alcohol abuse disorder or currently in treatment for alcohol-related problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Drinks Per Week	30 days	Average drinks based on 30 day timeline follow back of all alcohol consumption
Alcohol Related Consequences	30 days	Negative life events related to drinking assessed by the Brief Young Adult Alcohol Consequences Questionnaire. Calculates a total score from 0-48, with higher numbers indicating worse outcomes.

Secondary Outcome Measures

Name	Time	Method
Situational Confidence	12 weeks	Confidence in drinking resistance assessed by the Brief Situational Confidence Questionnaire. Scores 8 items from 0% to 100% confidence with higher scores indicating better confidence.
Protective Strategies	12 weeks	Skills in using alcohol-protective behaviors measured by the Protective Behavioral Strategies Survey. A 15-item survey, each item is scored from 0 to 6 to indicate use of behavioral strategies and the total score is a sum of all items. Higher scores indicate more (better) use of protective strategies.

Trial Locations

Locations (1)

The Miriam Hospital- CORO building; 🇺🇸 Providence, Rhode Island, United States