CARES: A Mobile Health Program for Alcohol Risk Reduction

March 11, 2025 updated by: Beth Bock, Ph.D., The Miriam Hospital

C.A.R.E.S.: A Mobile Health Program for Alcohol Risk Reduction for an Under- Served College Population

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

239

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • The Miriam Hospital- CORO building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CARES mobile app
Participants in this arm will receive 12 weeks of text messages and use of the smart phone mobile app that provides support for alcohol risk reduction.
Behavioral: CARES mobile smart phone app
The CARES smart phone mobile app contains a number of features to support safety while drinking and reduced alcohol consumption plus regular test messages for personal support
Active Comparator: Alcohol Education
Those randomized to the control arm will be given access to an online alcohol education intervention; Check Your Drinking (CYD: www.CheckYourDrinking.net). CYD provides normative feedback on the user's drinking habits relative to his/her peers.
Behavioral: Check Your Drinking
Check Your Drinking is an online alcohol assessment that provides normative feedback on the user's drinking habits relative to his/her peers. Alcohol interventions that provide normative feedback are rated by the NIAAA Alcohol Intervention Matrix as effective and low cost, and with few administrative or structural barriers to implementation thus making it suitable for community colleges.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drinks Per Week
Time Frame: 30 days
Average drinks based on 30 day timeline follow back of all alcohol consumption
30 days
Alcohol Related Consequences
Time Frame: 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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Situational Confidence
Time Frame: 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.
12 weeks
Protective Strategies
Time Frame: 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Beth C Bock, PhD, The Miriam Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2018

Primary Completion (Actual)

September 15, 2021

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

April 23, 2019

First Submitted That Met QC Criteria

April 23, 2019

First Posted (Actual)

April 25, 2019

Study Record Updates

Last Update Posted (Estimated)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7147117
  • R42AA026788 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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