Clinical trial NCT03927482: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-04-25
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Drinks Per Week
timeFrame: 30 days
measure: Alcohol Related Consequences
timeFrame: 30 days
Secondary outcomes:
measure: Situational Confidence
timeFrame: 12 weeks
measure: Protective Strategies
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital- CORO building
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Beth C Bock, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.