Expired Study
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Providence, Rhode Island 02903


Purpose:

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 summary:

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


Criteria:

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 is Available At:


Original ID:

1R21AA021014-01A1


NCT ID:

NCT02507115


Secondary ID:


Study Acronym:

TMAP


Brief Title:

Text Messaging as a Novel Alcohol Intervention for Community College Students


Official Title:

Text Messaging as a Novel Alcohol Intervention for Community College Students


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

28 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The Miriam Hospital


Oversight Authority:

United States: National Institutes of Health


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

65


Enrollment Type:

Actual


Study Dates

Start Date:July 2012
Completion Date:June 2015
Completion Type:Actual
Primary Completion Date:July 2014
Primary Completion Type:Actual
Verification Date:July 2015
Last Changed Date:April 23, 2019
First Received Date:July 22, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of heavy drinking episodes at six weeks
Time Frame:6 weeks
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:TMAP
Description:Text messages for Alcohol Risk Reduction
Arm Name:TMAP
Intervention Type:Behavioral
Name:Mojo Texts
Description:Motivational texts not alcohol related
Arm Name:Control

Study Arms

Study Arm Type:Sham Comparator
Arm Name:Control
Description:Motivational Text messages 4 days/week for 6 weeks
Study Arm Type:Experimental
Arm Name:TMAP
Description:Alcohol-related Text messages 4 days/week for 6 weeks

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:The Miriam Hospital
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Live Inspired, LLC

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:27450909
Reference Type:Reference
Citation: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.
PMID:25714907

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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