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

Primary Purpose

Alcohol Abuse, Alcohol Consumption, Drinking Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational and Normative Feedback
Self-Awareness
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Alcohol Abuse focused on measuring Alcohol, Abuse, Drinking, Behavior, Text, Computer

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh Medical Center Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Text message queries with feedback

Text message queries

Control

Arm Description

Weekly prompted queries about drinking behavior with personalized feedback.

Weekly prompted queries about drinking behavior

Weekly text reminders to complete final (12 week) instruments

Outcomes

Primary Outcome Measures

Ability of system to collect drinking information from young adults
We will report the proportion of weeks with completed drinking assessments in the EA and EA&I groups.

Secondary Outcome Measures

Number of binge drinking episodes in subjects as a measure of safety and efficacy
We will compare the number of binge drinking episodes between subjects in the three groups.

Full Information

First Posted
August 20, 2010
Last Updated
May 18, 2012
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT01197352
Brief Title
Pilot Study of a Text Message Platform to Reduce Risky Drinking in Young Adults
Acronym
PART
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Alcohol Consumption, Drinking Behavior
Keywords
Alcohol, Abuse, Drinking, Behavior, Text, Computer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text message queries with feedback
Arm Type
Experimental
Arm Description
Weekly prompted queries about drinking behavior with personalized feedback.
Arm Title
Text message queries
Arm Type
Active Comparator
Arm Description
Weekly prompted queries about drinking behavior
Arm Title
Control
Arm Type
No Intervention
Arm Description
Weekly text reminders to complete final (12 week) instruments
Intervention Type
Behavioral
Intervention Name(s)
Motivational and Normative Feedback
Intervention Description
Weekly feedback based on their frequency and degree of at-risk drinking behavior using normative, educational and motivational feedback
Intervention Type
Behavioral
Intervention Name(s)
Self-Awareness
Intervention Description
Weekly queries to raise awareness and allow self-reflection about drinking habits
Primary Outcome Measure Information:
Title
Ability of system to collect drinking information from young adults
Description
We will report the proportion of weeks with completed drinking assessments in the EA and EA&I groups.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of binge drinking episodes in subjects as a measure of safety and efficacy
Description
We will compare the number of binge drinking episodes between subjects in the three groups.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Pittsburgh Medical Center Emergency Department
City
Pittsburgh
State/Province
Pennsylvania
Country
United States

12. IPD Sharing Statement

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

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