<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/NCT01690026</url>
  </required_header>
  <id_info>
    <org_study_id>Project Options</org_study_id>
    <nct_id>NCT01690026</nct_id>
  </id_info>
  <brief_title>Facilitating Adolescent Self-Change for Alcohol Problems</brief_title>
  <official_title>Facilitating Adolescent Self-Change for Alcohol Problems</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This present multi-site investigation compares a voluntary brief intervention for adolescent&#xD;
      alcohol problems to an educational comparison condition. Measures are taken at intake and at&#xD;
      4 and 12 weeks post intake to determine effectiveness of the intervention to promote personal&#xD;
      change efforts and arrest progression of alcohol problems. This study tests cognitive&#xD;
      mechanisms of change and treatment characteristics and processes associated with youth&#xD;
      self-regulation to reduce or stop hazardous drinking.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alcohol use and problems</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive mediators</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1209</enrollment>
  <condition>Underage Drinking</condition>
  <arm_group>
    <arm_group_label>Brief intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Motivational intervention based brief intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard intervention condition</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivation interviewing based brief intervention</intervention_name>
    <arm_group_label>Brief intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Intervention</intervention_name>
    <arm_group_label>Standard intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All 9th-12th graders at six schools from 3 sites across the country are eligible to&#xD;
             participate, regardless of alcohol experience&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  exclusion prior to 9th grade and after 12th grade&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Drug Free Youth in Town</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33157-3459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55454-1495</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reed College</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97202-8199</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>November 1, 2017</last_update_submitted>
  <last_update_submitted_qc>November 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Sandra Brown</investigator_full_name>
    <investigator_title>Vice-Chancellor of Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcohol-Related Disorders</mesh_term>
    <mesh_term>Underage 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/NCT01690026
org study id: Project Options
nct id: NCT01690026
lead sponsor: 
has dmc: No
This present multi-site investigation compares a voluntary brief intervention for adolescent
      alcohol problems to an educational comparison condition. Measures are taken at intake and at
      4 and 12 weeks post intake to determine effectiveness of the intervention to promote personal
      change efforts and arrest progression of alcohol problems. This study tests cognitive
      mechanisms of change and treatment characteristics and processes associated with youth
      self-regulation to reduce or stop hazardous drinking.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Alcohol use and problems
time frame: one year
measure: Cognitive mediators
time frame: one year
arm group label: Brief intervention
arm group type: Other
description: Motivational intervention based brief intervention
arm group label: Standard intervention
arm group type: Other
description: Standard intervention condition
intervention type: Behavioral
intervention name: Motivation interviewing based brief intervention
arm group label: Brief intervention
intervention type: Behavioral
intervention name: Standard Intervention
arm group label: Standard intervention
criteria: 
gender: All
minimum age: 14 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Sandra Brown
investigator title: Vice-Chancellor of Research
mesh term: Alcohol-Related Disorders
mesh term: Underage Drinking