- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02507115
Text Messaging as a Novel Alcohol Intervention for Community College Students (TMAP)
April 23, 2019 updated by: The Miriam Hospital
This project will develop an intervention delivered through text messaging to reduce alcohol consumption and high risk drinking among adults who are enrolled as students in community colleges.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Heavy alcohol use among community college students is a serious problem, leaving students vulnerable to social and health impairment, physical or sexual assault, unintentional injuries, and death.
However, there have been limited efforts to research and treat community college students, despite these students comprising nearly 40% of all college students nationwide.
Community college students are diverse in ethnicity, age, socioeconomic status, living situation, and employment status.
Thus, successful interventions must be sufficiently flexible to apply across a diverse array of individual characteristics and needs.
Unfortunately, there is evidence of great unmet need among this group; community college students drive under the influence of alcohol more frequently than students at four-year colleges, and due to lesser time spent on campus, are less available for in-person interventions coordinated at their college.
The long-term objective of this research program is to address a gap in the treatment of heavy alcohol use by the community college population.
As a first step toward achieving that goal, this R21 application will develop an intervention that is tailored to the needs of community college students and which uses mobile communications platforms that are already used by the vast majority of this population.
Taking this approach, the intervention will be mobile, accessible wherever the user is located, and able to be tailored to individual characteristics.
The investigators will begin by presenting out initial intervention design to focus groups (4 groups heavy drinking community college students) and obtaining feedback from key informants (advisory board).
The investigators will use feedback from these groups to finalize the design and develop a working prototype, and will then pilot the intervention among heavy drinking community college students (N=10) for six weeks to test the usability and acceptability of the prototype intervention.
Participants will be interviewed at the end of the program to provide feedback and evaluate their experience with the system, and content experts will again evaluate the prototype using semi-structured interviews.
Finally, the investigators will pilot the modified intervention with heaving drinking community college students (N=40) for six weeks.
These participants will be randomly assigned to either the intervention program or a standard intervention (print self-help) with a contact-control.
Assessments will be conducted at end-of-treatment, and at 3 and 6 months follow up.
These data will be used to guide the planning of a full-scale clinical trial to test the efficacy and cost-effectiveness of the intervention in reducing hazardous drinking among community college students
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- The Miriam Hospital- CORO building
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 28 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 18 to 28 Community College student Consume at least 4 drinks in one sitting in the past week
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TMAP
Alcohol-related Text messages 4 days/week for 6 weeks
|
Text messages for Alcohol Risk Reduction
|
|
Sham Comparator: Control
Motivational Text messages 4 days/week for 6 weeks
|
Motivational texts not alcohol related
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of heavy drinking episodes at six weeks
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bock BC, Rosen RK, Barnett NP, Thind H, Walaska K, Foster R, Deutsch C, Traficante R. Translating Behavioral Interventions Onto mHealth Platforms: Developing Text Message Interventions for Smoking and Alcohol. JMIR Mhealth Uhealth. 2015 Feb 24;3(1):e22. doi: 10.2196/mhealth.3779.
- Bock BC, Barnett NP, Thind H, Rosen R, Walaska K, Traficante R, Foster R, Deutsch C, Fava JL, Scott-Sheldon LA. A text message intervention for alcohol risk reduction among community college students: TMAP. Addict Behav. 2016 Dec;63:107-13. doi: 10.1016/j.addbeh.2016.07.012. Epub 2016 Jul 18.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
July 22, 2015
First Submitted That Met QC Criteria
July 22, 2015
First Posted (Estimate)
July 23, 2015
Study Record Updates
Last Update Posted (Actual)
April 25, 2019
Last Update Submitted That Met QC Criteria
April 23, 2019
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R21AA021014-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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