<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/NCT01694082</url>
  </required_header>
  <id_info>
    <org_study_id>1207010596</org_study_id>
    <secondary_id>K01AA019694</secondary_id>
    <nct_id>NCT01694082</nct_id>
  </id_info>
  <brief_title>Brief Web-Based Alcohol Reduction Intervention for Undergraduates</brief_title>
  <official_title>Randomized, Controlled Trial of a Brief, Web-Based Alcohol Reduction Intervention for Undergraduates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alcoholic Beverage Medical Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tertiary Health Research Intervention Via Email (THRIVE; Kypri et al., 2009), originally&#xD;
      utilized with Australian students, is unique in that it contains efficacious components&#xD;
      derived from motivational interviewing (e.g., personalized feedback) and cognitive behavioral&#xD;
      therapy (protective behavioral strategies), yet is very brief and has established efficacy.&#xD;
      This study aims to test versions of THRIVE tailored to American college students. In addition&#xD;
      to replicating original results with THRIVE, we will also test versions containing unique&#xD;
      subsets of protective behavioral strategies to reduce alcohol consumption. The primary&#xD;
      hypothesis is that versions of THRIVE will be associated with lower overall alcohol&#xD;
      consumption than an assessment and brief brochure control condition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">November 2013</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of alcohol use</measure>
    <time_frame>1-month post-intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Protective behavioral strategy use</measure>
    <time_frame>1-month post-intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Weekly Alcohol Consumption</measure>
    <time_frame>1-month post-intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of heavy drinking days</measure>
    <time_frame>1-month post-intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of alcohol use</measure>
    <time_frame>6-months post-intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall weekly alcohol consumption</measure>
    <time_frame>6-months post-intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">207</enrollment>
  <condition>Alcohol Use</condition>
  <condition>Heavy Drinking</condition>
  <condition>Negative Consequences of Alcohol Use</condition>
  <arm_group>
    <arm_group_label>THRIVE replication</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this condition receive THRIVE with a full list of direct and indirect protective behavioral strategies to reduce alcohol consumption.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>THRIVE direct strategies</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this condition receive THRIVE including a subset of protective behavioral strategies that are directly related to alcohol drinking.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>THRIVE indirect strategies</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this condition receive THRIVE including a subset of protective behavioral strategies that are indirectly related to alcohol drinking.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brief brochure and assessment control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants will answer the same survey questions as participants in the THRIVE conditions, but will receive a brief alcohol-related brochure with only didactic content rather than the intervention components received by participants randomized to THRIVE conditions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>THRIVE</intervention_name>
    <description>THRIVE stands for (Tertiary Health Research Intervention Via Email). Participants complete questions related to demographics and their alcohol use and receive brief personalized feedback based on this information, in addition to protective behavioral strategies, facts about alcohol and information about available resources to reduce their alcohol use.</description>
    <arm_group_label>THRIVE direct strategies</arm_group_label>
    <arm_group_label>THRIVE indirect strategies</arm_group_label>
    <arm_group_label>THRIVE replication</arm_group_label>
    <other_name>Tertiary Health Research Intervention Via Email</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief brochure and assessment control</intervention_name>
    <arm_group_label>Brief brochure and assessment control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be a current student at Albertus Magnus College in New Haven, CT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  25 years of age or older&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert F Leeman, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>June 12, 2014</last_update_submitted>
  <last_update_submitted_qc>June 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yale University</investigator_affiliation>
    <investigator_full_name>Robert Leeman</investigator_full_name>
    <investigator_title>Assistant Professor of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>brief intervention</keyword>
  <keyword>web-based interventions</keyword>
  <keyword>computer-based interventions</keyword>
  <keyword>harm reduction</keyword>
  <keyword>young adult</keyword>
  <keyword>college student</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT01694082
org study id: 1207010596
secondary id: K01AA019694
nct id: NCT01694082
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Tertiary Health Research Intervention Via Email (THRIVE; Kypri et al., 2009), originally
      utilized with Australian students, is unique in that it contains efficacious components
      derived from motivational interviewing (e.g., personalized feedback) and cognitive behavioral
      therapy (protective behavioral strategies), yet is very brief and has established efficacy.
      This study aims to test versions of THRIVE tailored to American college students. In addition
      to replicating original results with THRIVE, we will also test versions containing unique
      subsets of protective behavioral strategies to reduce alcohol consumption. The primary
      hypothesis is that versions of THRIVE will be associated with lower overall alcohol
      consumption than an assessment and brief brochure control condition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Frequency of alcohol use
time frame: 1-month post-intervention
measure: Protective behavioral strategy use
time frame: 1-month post-intervention
measure: Overall Weekly Alcohol Consumption
time frame: 1-month post-intervention
measure: Frequency of heavy drinking days
time frame: 1-month post-intervention
measure: Frequency of alcohol use
time frame: 6-months post-intervention
measure: Overall weekly alcohol consumption
time frame: 6-months post-intervention
arm group label: THRIVE replication
arm group type: Experimental
description: Participants in this condition receive THRIVE with a full list of direct and indirect protective behavioral strategies to reduce alcohol consumption.
arm group label: THRIVE direct strategies
arm group type: Experimental
description: Participants in this condition receive THRIVE including a subset of protective behavioral strategies that are directly related to alcohol drinking.
arm group label: THRIVE indirect strategies
arm group type: Experimental
description: Participants in this condition receive THRIVE including a subset of protective behavioral strategies that are indirectly related to alcohol drinking.
arm group label: Brief brochure and assessment control
arm group type: Sham Comparator
description: Participants will answer the same survey questions as participants in the THRIVE conditions, but will receive a brief alcohol-related brochure with only didactic content rather than the intervention components received by participants randomized to THRIVE conditions.
intervention type: Behavioral
intervention name: THRIVE
description: THRIVE stands for (Tertiary Health Research Intervention Via Email). Participants complete questions related to demographics and their alcohol use and receive brief personalized feedback based on this information, in addition to protective behavioral strategies, facts about alcohol and information about available resources to reduce their alcohol use.
arm group label: THRIVE direct strategies
arm group label: THRIVE indirect strategies
arm group label: THRIVE replication
other name: Tertiary Health Research Intervention Via Email
intervention type: Behavioral
intervention name: Brief brochure and assessment control
arm group label: Brief brochure and assessment control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Robert F Leeman, Ph.D.
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Yale University
investigator full name: Robert Leeman
investigator title: Assistant Professor of Psychiatry
mesh term: Alcohol Drinking