CClinicalTrials.gg
CompletedNCT01197352PARTUpdated May 21, 2012

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

An interventional study of Motivational and Normative Feedback and Self-Awareness in Alcohol Abuse, Alcohol Consumption and Drinking Behavior, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years to 24 Years. Per ClinicalTrials.gov, last updated 2012-05-21.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 24 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Alcohol Abuse
  • Alcohol Consumption
  • Drinking Behavior

Keywords

  • Alcohol
  • Abuse
  • Drinking
  • Behavior
  • Text
  • Computer
03

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant
  • Prisoner
  • Treated for alcohol dependence or abuse
  • Treated for psychiatric disorder
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Text message queries with feedback

    Weekly prompted queries about drinking behavior with personalized feedback.

    Behavioral: Motivational and Normative Feedback

  • Active comparator
    Text message queries

    Weekly prompted queries about drinking behavior

    Behavioral: Self-Awareness

  • No intervention
    Control

    Weekly text reminders to complete final (12 week) instruments

Interventions

  • BehavioralMotivational and Normative Feedback

    Weekly feedback based on their frequency and degree of at-risk drinking behavior using normative, educational and motivational feedback

  • BehavioralSelf-Awareness

    Weekly queries to raise awareness and allow self-reflection about drinking habits

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 weeks

06

Study locations

1 site
  • University of Pittsburgh Medical Center Emergency Department
    Pittsburgh, Pennsylvania, United States
07

Registry details

Key details

Study ID
NCT01197352
Lead sponsor
University of Pittsburgh
Responsible party
Sponsor
First posted
Sep 9, 2010
Start date
Aug 2010
Primary completion
Feb 2011
Completion
Feb 2011
Last update
May 21, 2012

Oversight

Data monitoring committee
Yes
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