CARES: A Mobile Health Program for Alcohol Risk Reduction

NCT ID: NCT03927482

Last Updated: 2025-03-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-02

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Alcohol Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Assessors will be blind to the participant's randomization assignment

Study Groups

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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.

Group Type EXPERIMENTAL

CARES mobile smart phone app

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Check Your Drinking

Intervention Type BEHAVIORAL

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.

Interventions

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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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Beth Bock, Ph.D.

Senior Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Beth C Bock, PhD

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital

Locations

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The Miriam Hospital- CORO building

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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Bock B, Deutsch C, Dunsiger S, Rosen RK, Walaska K, Lantini R, Foster R. C.A.R.E.S: A mobile health program for alcohol risk reduction in community college students. Contemp Clin Trials. 2021 Aug;107:106493. doi: 10.1016/j.cct.2021.106493. Epub 2021 Jun 26.

Reference Type DERIVED
PMID: 34182157 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R42AA026788

Identifier Type: NIH

Identifier Source: secondary_id

View Link

7147117

Identifier Type: -

Identifier Source: org_study_id

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