Pilot Study of a Text Message Platform to Reduce Risky Drinking in Young Adults (PART)

May 18, 2012 updated by: University of Pittsburgh

Pilot Study of a Computer-driven Platform That Uses Text Messages to Collect Drinking Information and Deliver Personalized Motivational Messages to At-risk Young Adults

Young adults are in a critical period where they can be influenced to avoid a trajectory of high-risk drinking and harmful outcomes in the later adult years. The Emergency Department might offer a unique opportunity to reach young adults, if an easy to implement screening, brief intervention and referral to treatment was available. The investigators are investigating the feasibility and accuracy of ED-initiated and outpatient-continued assessment of drinking behavior in young adults using a computer-driven text messaging platform. Based on the subject's response to weekly assessments, the computer platform will send personalized motivational messages in real-time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Greater than 45% of young adults have heavy episodic drinking (HED; 5/4 drinks per occasion form men/women), resulting in significant health risks, including injury and death. Early identification and secondary prevention of HED using screening, brief interventions and referral to treatment (SBIRT) is advocated by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) as a way to reduce injury and health consequences. Each day in the United States, there are over 2700 emergency department (ED) visits associated with alcohol, unfortunately, SBIRT is rarely performed in the ED due to time and training requirements. Our application seeks to solve this problem by integrating SBIRT into ED care through the use of ecological assessments with interventions. We will incorporate components of the NIAAA 2005 Clinicians Guide into automated weekly assessments (EA) and branching algorithms for personalized interventions (EA&I) delivered in real-time through mobile phone text messaging to young adults with a history of at-risk drinking behavior. We will assess the feasibility of EA&I to study young adults with a history of at-risk drinking and assess the variability in outcomes in patients undergoing EA&I, EA or standard care. We expect to find that this ED-initiated and outpatientcontinued platform will improve collection of drinking behavior, delivery of real-world motivational feedback and follow-up in young adults with at-risk drinking histories. We anticipate that short-term HED will be reduced in those subjects randomized to EA&I. We will use this information to support further studies with adequate power to show ED-initiated EA&I reduce long-term HED and its adverse consequences in young adults.

Study Type

Interventional

Enrollment (Actual)

45

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

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • University of Pittsburgh Medical Center Emergency Department

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 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-24 years
  • English speaking
  • Owns a personal phone with text messaging

Exclusion Criteria:

  • Pregnant
  • Prisoner
  • Treated for alcohol dependence or abuse
  • Treated for psychiatric 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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Text message queries with feedback
Weekly prompted queries about drinking behavior with personalized feedback.
Behavioral: Motivational and Normative Feedback
Weekly feedback based on their frequency and degree of at-risk drinking behavior using normative, educational and motivational feedback
Active Comparator: Text message queries
Weekly prompted queries about drinking behavior
Behavioral: Self-Awareness
Weekly queries to raise awareness and allow self-reflection about drinking habits
No Intervention: Control
Weekly text reminders to complete final (12 week) instruments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability of system to collect drinking information from young adults
Time Frame: 12 weeks
We will report the proportion of weeks with completed drinking assessments in the EA and EA&I groups.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of binge drinking episodes in subjects as a measure of safety and efficacy
Time Frame: 12 weeks
We will compare the number of binge drinking episodes between subjects in the three groups.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

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

August 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

August 20, 2010

First Submitted That Met QC Criteria

September 7, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Estimate)

May 21, 2012

Last Update Submitted That Met QC Criteria

May 18, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO10040186

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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