<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01688245</url>
  </required_header>
  <id_info>
    <org_study_id>PRO12080344</org_study_id>
    <nct_id>NCT01688245</nct_id>
  </id_info>
  <brief_title>A Text Message Behavioral Intervention to Reduce Alcohol Consumption in Young Adults</brief_title>
  <acronym>TRAC</acronym>
  <official_title>A Text Message Behavioral Intervention to Reduce Alcohol Consumption in Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators aim to test the effectiveness of a text-message-based behaivoral intervention&#xD;
      in reducing binge drinking among young adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Alcohol consumption, especially in the form of heavy episodic drinking (bingeing), is common&#xD;
      among young adults. Despite high rates of illness and injury associated with heavy episodic&#xD;
      drinking, many young adults are not aware of the risks, few seek help for their drinking and&#xD;
      many at-risk are not exposed to prevention-based intervention. Opportunistic screening in&#xD;
      hospital Emergency Departments (EDs) tied to behavioral interventions has the potential to&#xD;
      prevent future alcohol-related harm among young adults, but efficacy across outcomes has been&#xD;
      mixed and large-scale implementation of prevention programs is low. Given the rapidly growing&#xD;
      use of cell phone text-messaging (SMS) as a primary form of communication among young adults,&#xD;
      SMS could be used to deliver health prevention interventions. We will recruit young adults&#xD;
      identified in the ED with hazardous drinking behavior in a 3-arm randomized controlled trial&#xD;
      to test the hypothesis that exposure to a 12-week SMS program will result in immediate&#xD;
      (3-month) and lasting (6-, and 9-month) decreases in alcohol consumption.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Timeline Follow-back Procedure</measure>
    <time_frame>30 Days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Injury Behavior Checklist</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">765</enrollment>
  <condition>Alcohol Consumption</condition>
  <condition>Alcohol Intoxication</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No SMS dialog</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMS Assessments</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Weekly post-weekend drinking outcome assessments</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMS Assessments &amp; Feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weekly pre-weekend drinking intention &amp; post-weekend drinking outcome assessments with personalized feedback and harm-reduction support</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SMS Assessments &amp; Feedback</intervention_name>
    <description>Weekly pre-weekend drinking plan and post-weekend drinking outcome assessments with personlaized feedback</description>
    <arm_group_label>SMS Assessments &amp; Feedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SMS Assessments</intervention_name>
    <description>Weekly post-weekend drinking outcome assessments</description>
    <arm_group_label>SMS Assessments</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AUDIT-C score 3 or more for women and 4 or more for men&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current treatment for psychiatric disease&#xD;
&#xD;
          -  Any prior treatment for drug or alcohol use disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian P Suffoletto, MD MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center-Mercy Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>May 26, 2015</last_update_submitted>
  <last_update_submitted_qc>May 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>young adults</keyword>
  <keyword>alcohol consumption</keyword>
  <keyword>mobile health</keyword>
  <keyword>text message</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholic Intoxication</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01688245
org study id: PRO12080344
nct id: NCT01688245
lead sponsor: 
has dmc: Yes
Investigators aim to test the effectiveness of a text-message-based behaivoral intervention
      in reducing binge drinking among young adults.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Timeline Follow-back Procedure
time frame: 30 Days
measure: Injury Behavior Checklist
time frame: 3 months
arm group label: Control
arm group type: No Intervention
description: No SMS dialog
arm group label: SMS Assessments
arm group type: Active Comparator
description: Weekly post-weekend drinking outcome assessments
arm group label: SMS Assessments & Feedback
arm group type: Experimental
description: Weekly pre-weekend drinking intention & post-weekend drinking outcome assessments with personalized feedback and harm-reduction support
intervention type: Behavioral
intervention name: SMS Assessments & Feedback
description: Weekly pre-weekend drinking plan and post-weekend drinking outcome assessments with personlaized feedback
arm group label: SMS Assessments & Feedback
intervention type: Behavioral
intervention name: SMS Assessments
description: Weekly post-weekend drinking outcome assessments
arm group label: SMS Assessments
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: No
last name: Brian P Suffoletto, MD MS
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alcoholic Intoxication
mesh term: Alcohol Drinking