NCT03927482

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
7 months until next milestone

Results Posted

Study results publicly available

August 31, 2022

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

3.1 years

First QC Date

April 23, 2019

Results QC Date

August 8, 2022

Last Update Submit

March 11, 2025

Conditions

Alcohol Abuse

Outcome Measures

Primary Outcomes (2)

  • Drinks Per Week

    Average drinks based on 30 day timeline follow back of all alcohol consumption

    30 days

  • 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.

    30 days

Secondary Outcomes (2)

  • Situational Confidence

    12 weeks

  • Protective Strategies

    12 weeks

Study Arms (2)

CARES mobile app

EXPERIMENTAL

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

Alcohol Education

ACTIVE COMPARATOR

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

Interventions

CARES mobile smart phone appBEHAVIORAL

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

CARES mobile app
Check Your DrinkingBEHAVIORAL

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.

Alcohol Education

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital- CORO building

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • 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.

    PMID: 34182157DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Beth Bock, PhD
Organization
The Miriam Hospital
Beth_Bock@Brown.edu
4017938020

Study Officials

  • Beth C Bock, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessors will be blind to the participant's randomization assignment
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

April 23, 2019

First Posted

April 25, 2019

Study Start

August 2, 2018

Primary Completion

September 15, 2021

Study Completion

January 31, 2022

Last Updated

March 26, 2025

Results First Posted

August 31, 2022

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)