- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01688245
A Text Message Behavioral Intervention to Reduce Alcohol Consumption in Young Adults (TRAC)
May 26, 2015 updated by: University of Pittsburgh
Investigators aim to test the effectiveness of a text-message-based behaivoral intervention in reducing binge drinking among young adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Alcohol consumption, especially in the form of heavy episodic drinking (bingeing), is common among young adults.
Despite high rates of illness and injury associated with heavy episodic drinking, many young adults are not aware of the risks, few seek help for their drinking and many at-risk are not exposed to prevention-based intervention.
Opportunistic screening in hospital Emergency Departments (EDs) tied to behavioral interventions has the potential to prevent future alcohol-related harm among young adults, but efficacy across outcomes has been mixed and large-scale implementation of prevention programs is low.
Given the rapidly growing use of cell phone text-messaging (SMS) as a primary form of communication among young adults, SMS could be used to deliver health prevention interventions.
We will recruit young adults identified in the ED with hazardous drinking behavior in a 3-arm randomized controlled trial to test the hypothesis that exposure to a 12-week SMS program will result in immediate (3-month) and lasting (6-, and 9-month) decreases in alcohol consumption.
Study Type
Interventional
Enrollment (Actual)
765
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
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15221
- University of Pittsburgh Medical Center-Mercy Hospital
-
-
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 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- AUDIT-C score 3 or more for women and 4 or more for men
Exclusion Criteria:
- Current treatment for psychiatric disease
- Any prior treatment for drug or alcohol use disorder
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
No SMS dialog
|
|
Active Comparator: SMS Assessments
Weekly post-weekend drinking outcome assessments
|
Weekly post-weekend drinking outcome assessments
|
Experimental: SMS Assessments & Feedback
Weekly pre-weekend drinking intention & post-weekend drinking outcome assessments with personalized feedback and harm-reduction support
|
Weekly pre-weekend drinking plan and post-weekend drinking outcome assessments with personlaized feedback
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Timeline Follow-back Procedure
Time Frame: 30 Days
|
30 Days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Injury Behavior Checklist
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brian P Suffoletto, MD MS, University of Pittsburgh
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
- Suffoletto B, Kristan J, Chung T, Jeong K, Fabio A, Monti P, Clark DB. An Interactive Text Message Intervention to Reduce Binge Drinking in Young Adults: A Randomized Controlled Trial with 9-Month Outcomes. PLoS One. 2015 Nov 18;10(11):e0142877. doi: 10.1371/journal.pone.0142877. eCollection 2015.
- Suffoletto B, Callaway CW, Kristan J, Monti P, Clark DB. Mobile phone text message intervention to reduce binge drinking among young adults: study protocol for a randomized controlled trial. Trials. 2013 Apr 3;14:93. doi: 10.1186/1745-6215-14-93.
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
November 1, 2012
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
September 14, 2012
First Submitted That Met QC Criteria
September 14, 2012
First Posted (Estimate)
September 19, 2012
Study Record Updates
Last Update Posted (Estimate)
May 27, 2015
Last Update Submitted That Met QC Criteria
May 26, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO12080344
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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