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CARES: A Mobile Health Program for Alcohol Risk Reduction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927482
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : April 29, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Beth Bock, Ph.D., 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.

Condition or disease Intervention/treatment Phase
Alcohol Abuse Behavioral: CARES mobile smart phone app Behavioral: Check Your Drinking Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Assessors will be blind to the participant's randomization assignment
Primary Purpose: Prevention
Official Title: C.A.R.E.S.: A Mobile Health Program for Alcohol Risk Reduction for an Under- Served College Population
Actual Study Start Date : August 2, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : July 2021

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.




Primary Outcome Measures :
  1. Alcohol Use Timeline Follow Back [ Time Frame: 12 weeks ]
    30 day timeline follow back of all alcohol consumption

  2. Alcohol Related Consequences [ Time Frame: 12 weeks ]
    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 :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927482


Contacts
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Contact: Beth C Bock, PhD 401-793-8020 Beth_Bock@Brown.edu
Contact: Kristen Walaska, BS 401-793-8022 KWalaska@Lifespan.org

Locations
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United States, Rhode Island
The Miriam Hospital- CORO building Recruiting
Providence, Rhode Island, United States, 02903
Contact: Beth C Bock, PhD    401-793-8020    Beth_Bock@Brown.edu   
Contact: Kristen Walaska, BS    401-793-8022    KWalaska@Lifespan.org   
Principal Investigator: Beth C Bock, PhD         
Sponsors and Collaborators
The Miriam Hospital
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Beth C Bock, PhD The Miriam Hospital
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Responsible Party: Beth Bock, Ph.D., Senior Research Scientist, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT03927482    
Other Study ID Numbers: 7147117
R42AA026788 ( U.S. NIH Grant/Contract )
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders