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CARES: A Mobile Health Program for Alcohol Risk Reduction

Primary Purpose

Alcohol Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CARES mobile smart phone app
Check Your Drinking
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Abuse

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Miriam Hospital- CORO building

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CARES mobile app

Alcohol Education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Drinks Per Week
Average drinks based on 30 day timeline follow back of all alcohol consumption
Alcohol Related Consequences
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

Situational Confidence
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
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.

Full Information

First Posted
April 23, 2019
Last Updated
August 8, 2022
Sponsor
The Miriam Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03927482
Brief Title
CARES: A Mobile Health Program for Alcohol Risk Reduction
Official Title
C.A.R.E.S.: A Mobile Health Program for Alcohol Risk Reduction for an Under- Served College Population
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 2, 2018 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Assessors will be blind to the participant's randomization assignment
Allocation
Randomized
Enrollment
283 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CARES mobile app
Arm Type
Experimental
Arm Description
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.
Arm Title
Alcohol Education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CARES mobile smart phone app
Intervention Description
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
Intervention Name(s)
Check Your Drinking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Drinks Per Week
Description
Average drinks based on 30 day timeline follow back of all alcohol consumption
Time Frame
30 days
Title
Alcohol Related Consequences
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Situational Confidence
Description
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.
Time Frame
12 weeks
Title
Protective Strategies
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth C Bock, PhD
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Miriam Hospital- CORO building
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34182157
Citation
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.
Results Reference
derived

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CARES: A Mobile Health Program for Alcohol Risk Reduction

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