<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/NCT02228967</url>
  </required_header>
  <id_info>
    <org_study_id>W81XWH-14-2-0014</org_study_id>
    <secondary_id>12019006</secondary_id>
    <nct_id>NCT02228967</nct_id>
  </id_info>
  <brief_title>Alcohol Screening, Brief Intervention, and Referral to Treatment in a Military Treatment Facility</brief_title>
  <official_title>Feasibility and Pilot Testing of SBI to Reduce Alcohol Misuse Among Active Duty Members in a Military ER Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Diego State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Naval Medical Center, San Diego</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>San Diego State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) approach will be&#xD;
      adapted for use in a large military hospital setting, and then pilot tested in a military&#xD;
      emergency department (ED) to assess its potential for effectiveness and for further testing&#xD;
      in a large-scale trial. SBIRT is an &quot;opportunistic&quot; approach whereby all adult patients in&#xD;
      the ED are screened by Health Educators for their alcohol use, and then, taking advantage of&#xD;
      a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level&#xD;
      of risk.&#xD;
&#xD;
      The feasibility/formative research activities in the first phase (Phase I) of the study are&#xD;
      not summative research, and therefore, do not lend themselves to testable hypotheses.&#xD;
      Hypotheses with regard to the pilot randomized trial in Phase II are as follows:&#xD;
&#xD;
        1. Participants in the SBIRT intervention will show relatively greater reductions over a&#xD;
           six month period (or less increase) than the brochure/usual care control group in the&#xD;
           prevalence of past-month heavy drinking, frequency of heavy drinking, past week number&#xD;
           of drinks, and the AUDIT-based drinkers' index.&#xD;
&#xD;
        2. Alcohol use-related motivation/readiness to change and controlled drinking self-efficacy&#xD;
           will show greater change in the SBIRT intervention group relative to the brochure/usual&#xD;
           care control group.&#xD;
&#xD;
           In addition, exploratory analyses will examine the following:&#xD;
&#xD;
        3. Sociodemographic/military variables (e.g., age, race/ethnicity, gender, branch of&#xD;
           service, officer/enlisted status, PTS) and social-psychological factors (e.g., baseline&#xD;
           readiness to change, self efficacy) will mediate or moderate changes in alcohol misuse.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Deployment frequency and duration and combat exposure are implicated as risk factors for&#xD;
      alcohol misuse and PTSD among military personnel. During the past 10 years, Department of&#xD;
      Defense healthcare systems have observed steep increases in mental health and substance use&#xD;
      services among personnel demobilizing from these conflicts. Although the alcohol Screening,&#xD;
      Brief Intervention and Referral to Treatment (SBIRT) approach has shown promise as a&#xD;
      low-cost, effective strategy for reducing alcohol use in civilians many of whom are risky&#xD;
      drinkers but not yet dependent, it has not been adapted or tested in military health care&#xD;
      settings for active duty personnel. This 2.5 year civilian-military collaborative study is&#xD;
      highly responsive to exploring solutions to this emerging issue. The specific objectives for&#xD;
      the overall project are given below.&#xD;
&#xD;
      Objective 1: Feasibility and Acceptability&#xD;
&#xD;
        -  Determine how the SBIRT intervention can be integrated into standard military emergency&#xD;
           department (ED) operations by conducting record review and observation of the ED.&#xD;
&#xD;
        -  Develop and test the acceptability and usability (for both ED staff and potential&#xD;
           participants) of the SBIRT approach by conducting focus groups with active duty&#xD;
           personnel and garnering input from ED staff.&#xD;
&#xD;
        -  Develop an implementation/operations protocol for delivering SBIRT in the ED.&#xD;
&#xD;
      Objective 2: Adaptation&#xD;
&#xD;
        -  Apply a translational research approach to adapt SBIRT implementation in military&#xD;
           settings and populations by using information from focus groups and input from ED staff.&#xD;
&#xD;
        -  Adapt the content of the SBIRT intervention to be relevant for military personnel,&#xD;
           including language and images for counseling and materials using information from focus&#xD;
           groups and input from ED staff.&#xD;
&#xD;
      Objective 3: Pilot Trial&#xD;
&#xD;
        -  Using a two group repeated measures design, assess the impact of SBIRT using&#xD;
           standardized alcohol use measures to assess its potential for effectiveness with active&#xD;
           duty military personnel in an ED setting. Specific methodologies include:&#xD;
&#xD;
        -  Apply a randomization method in the ED to assign active duty participants to&#xD;
           experimental condition.&#xD;
&#xD;
        -  Implement the SBIRT intervention in the ED for those assigned to the intervention arm.&#xD;
&#xD;
        -  Implement a process for obtaining follow-up data with this mobile population.&#xD;
&#xD;
        -  Assess presumed mediators (e.g., readiness/motivation to change and self-efficacy) and&#xD;
           moderators (e.g., PTSD status, gender) of alcohol misuse change.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2015</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">October 2016</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 (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alcohol Use Disorders Identification Test (AUDIT) Total</measure>
    <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
    <description>The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUDIT-C or Drinkers Index</measure>
    <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
    <description>The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Controlled Drinking Self-Efficacy Scale (CDSES)</measure>
    <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
    <description>The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readiness to Change Scale</measure>
    <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
    <description>A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">791</enrollment>
  <condition>Alcohol Dependency</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SBIRT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SBIRT</intervention_name>
    <description>SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
    <arm_group_label>SBIRT</arm_group_label>
    <other_name>Screening</other_name>
    <other_name>Brief Intervention</other_name>
    <other_name>Brief Treatment</other_name>
    <other_name>Referral to Treatment</other_name>
    <other_name>Motivational Interviewing</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 or Older&#xD;
&#xD;
          -  Active Duty&#xD;
&#xD;
          -  Off Duty&#xD;
&#xD;
          -  Telephone Number for Follow-up&#xD;
&#xD;
          -  Healthy Enough to Participate&#xD;
&#xD;
          -  Positive Screen for Risky Drinking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18&#xD;
&#xD;
          -  Non-Military&#xD;
&#xD;
          -  On Duty&#xD;
&#xD;
          -  Low Level Drinking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Reed, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SDSURF - Center for Alcohol &amp; Drug Studies &amp; Services</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gerard DeMers, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>United States Naval Medical Center, San Diego</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Naval Medical Center San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <results_first_submitted>November 7, 2018</results_first_submitted>
  <results_first_submitted_qc>May 29, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 25, 2019</results_first_posted>
  <last_update_submitted>August 21, 2020</last_update_submitted>
  <last_update_submitted_qc>August 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Diego State University</investigator_affiliation>
    <investigator_full_name>Mark Reed, PhD</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>Alcohol Use</keyword>
  <keyword>SBIRT</keyword>
  <keyword>Military</keyword>
  <keyword>Health Behavior</keyword>
  <keyword>Emergency Room</keyword>
  <keyword>Health Promotion</keyword>
  <keyword>Formative Research</keyword>
  <keyword>Randomized Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Usual Care</title>
          <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
        </group>
        <group group_id="P2">
          <title>SBIRT</title>
          <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="403"/>
                <participants group_id="P2" count="388"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="244"/>
                <participants group_id="P2" count="228"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="159"/>
                <participants group_id="P2" count="160"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="146"/>
                <participants group_id="P2" count="142"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Usual Care</title>
          <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
        </group>
        <group group_id="B2">
          <title>SBIRT</title>
          <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="403"/>
            <count group_id="B2" value="388"/>
            <count group_id="B3" value="791"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.4" spread="6"/>
                    <measurement group_id="B2" value="26.3" spread="5.7"/>
                    <measurement group_id="B3" value="26.3" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                    <measurement group_id="B2" value="108"/>
                    <measurement group_id="B3" value="211"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="300"/>
                    <measurement group_id="B2" value="280"/>
                    <measurement group_id="B3" value="580"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hispanic/Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African-American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="215"/>
                    <measurement group_id="B2" value="214"/>
                    <measurement group_id="B3" value="429"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian/Hawaiian/Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian/Alaskan Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="403"/>
                    <measurement group_id="B2" value="388"/>
                    <measurement group_id="B3" value="791"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-Reported PTSD Diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="387"/>
                    <measurement group_id="B2" value="367"/>
                    <measurement group_id="B3" value="754"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Single</title>
                  <measurement_list>
                    <measurement group_id="B1" value="203"/>
                    <measurement group_id="B2" value="185"/>
                    <measurement group_id="B3" value="388"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Married/Co-habitating</title>
                  <measurement_list>
                    <measurement group_id="B1" value="161"/>
                    <measurement group_id="B2" value="173"/>
                    <measurement group_id="B3" value="334"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Divorced/Separated/Widowed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education Level</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>High School Graduate/GED</title>
                  <measurement_list>
                    <measurement group_id="B1" value="169"/>
                    <measurement group_id="B2" value="149"/>
                    <measurement group_id="B3" value="318"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Some College</title>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                    <measurement group_id="B2" value="128"/>
                    <measurement group_id="B3" value="251"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2-Year College Degree (AA)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="95"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4-Year Degree (BA/BS)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="96"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Graduate Degree</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Service Branch</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Navy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="336"/>
                    <measurement group_id="B2" value="320"/>
                    <measurement group_id="B3" value="656"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Marine Corps</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="111"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Army/Air Force/Coast Guard</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Combat Deployments (past 5-years)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="B1" value="211"/>
                    <measurement group_id="B2" value="214"/>
                    <measurement group_id="B3" value="425"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1-2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="173"/>
                    <measurement group_id="B2" value="148"/>
                    <measurement group_id="B3" value="321"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 or more</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Alcohol Use Disorders Identification Test (AUDIT) Score</title>
          <description>The AUDIT is the Alcohol Use Disorders identification test (Babor et al., 2001). The AUDIT is a screening assessment designed to help identify risky drinking. The AUDIT ranges from a score of 0 to 40 with higher values indicating riskier drinking.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.7" spread="4.2"/>
                    <measurement group_id="B2" value="8.0" spread="5.1"/>
                    <measurement group_id="B3" value="7.7" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Readiness to Change Drinking</title>
          <description>A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.95" spread="1.17"/>
                    <measurement group_id="B2" value="1.96" spread="1.15"/>
                    <measurement group_id="B3" value="1.96" spread="1.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Controlled Drinking Self-Efficacy Scale (CDSES)</title>
          <description>The 20-item Controlled Drinking Self-Efficacy Scale (CDSES; Sitharthan et al., 2003), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with higher scores indicating more confidence to engage in controlled drinking. Items for the CDSES will be combined and averaged to form a scaled score.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76.9" spread="15.3"/>
                    <measurement group_id="B2" value="78" spread="15"/>
                    <measurement group_id="B3" value="77.9" spread="15.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Alcohol Use Disorders Identification Test (AUDIT) Total</title>
        <description>The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.</description>
        <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
        <population>Excludes low-risk participants defined as AUDIT &lt;=7 at baseline. A total of 17 participants were excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
          </group>
          <group group_id="O2">
            <title>SBIRT</title>
            <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Use Disorders Identification Test (AUDIT) Total</title>
          <description>The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.</description>
          <population>Excludes low-risk participants defined as AUDIT &lt;=7 at baseline. A total of 17 participants were excluded from the analysis.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="240"/>
                <count group_id="O2" value="215"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.91" spread="0.26"/>
                    <measurement group_id="O2" value="5.5" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>=0.274</p_value>
            <p_value_desc>A priori threshold for statistical significance was 0.05</p_value_desc>
            <method>Repeated Measures--General Linear Model</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUDIT-C or Drinkers Index</title>
        <description>The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.</description>
        <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
        <population>Excludes low-risk participants defined as AUDIT &lt;=7 at baseline. A total of 17 participants were excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
          </group>
          <group group_id="O2">
            <title>SBIRT</title>
            <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
          </group>
        </group_list>
        <measure>
          <title>AUDIT-C or Drinkers Index</title>
          <description>The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.</description>
          <population>Excludes low-risk participants defined as AUDIT &lt;=7 at baseline. A total of 17 participants were excluded from the analysis.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="240"/>
                <count group_id="O2" value="215"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.41" spread="0.14"/>
                    <measurement group_id="O2" value="4.05" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>=0.083</p_value>
            <method>Repeated Measures--General Linear Model</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Controlled Drinking Self-Efficacy Scale (CDSES)</title>
        <description>The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.</description>
        <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
        <population>Excludes low-risk participants defined as AUDIT &lt;=7 at baseline. A total of 17 participants were excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
          </group>
          <group group_id="O2">
            <title>SBIRT</title>
            <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
          </group>
        </group_list>
        <measure>
          <title>Controlled Drinking Self-Efficacy Scale (CDSES)</title>
          <description>The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.</description>
          <population>Excludes low-risk participants defined as AUDIT &lt;=7 at baseline. A total of 17 participants were excluded from the analysis.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="240"/>
                <count group_id="O2" value="215"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.42" spread="1.01"/>
                    <measurement group_id="O2" value="81.67" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>=0.028</p_value>
            <method>Repeated Measures--General Linear Model</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Readiness to Change Scale</title>
        <description>A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.</description>
        <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
        <population>Excludes low-risk participants defined as AUDIT &lt;=7 at baseline. A total of 17 participants were excluded from the analysis as they were low-risk at baseline. Additionally, missing data on the Readiness to Change measure resulted in a total of 444 participants for this analysis. Six were missing from usual care and five were missing from SBIRT.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
          </group>
          <group group_id="O2">
            <title>SBIRT</title>
            <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
          </group>
        </group_list>
        <measure>
          <title>Readiness to Change Scale</title>
          <description>A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.</description>
          <population>Excludes low-risk participants defined as AUDIT &lt;=7 at baseline. A total of 17 participants were excluded from the analysis as they were low-risk at baseline. Additionally, missing data on the Readiness to Change measure resulted in a total of 444 participants for this analysis. Six were missing from usual care and five were missing from SBIRT.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="234"/>
                <count group_id="O2" value="210"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.23" spread="0.08"/>
                    <measurement group_id="O2" value="2.19" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>=0.708</p_value>
            <method>Repeated Measures--General Linear Model</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis II)</title>
        <description>The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.</description>
        <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
        <population>For this study, at-risk drinking was defined as: AUDIT total &gt;=8, under 21 drinker, any past year heavy episodic drinking (HED). Excludes at-risk participants defined as any amount of HED (AUDIT Question 3 &gt; 0) or under 21 drinker at baseline. A total of 281 participants were excluded from this analysis (N = 190)</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
          </group>
          <group group_id="O2">
            <title>SBIRT</title>
            <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis II)</title>
          <description>The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.</description>
          <population>For this study, at-risk drinking was defined as: AUDIT total &gt;=8, under 21 drinker, any past year heavy episodic drinking (HED). Excludes at-risk participants defined as any amount of HED (AUDIT Question 3 &gt; 0) or under 21 drinker at baseline. A total of 281 participants were excluded from this analysis (N = 190)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" spread="0.47"/>
                    <measurement group_id="O2" value="7.31" spread="0.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Data were analyzed using a GLM repeated measures approach. A priori means comparisons tets (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>=0.197</p_value>
            <p_value_desc>A priori threshold for statistical significance was 0.05.</p_value_desc>
            <method>Repeated Measures--General Linear Model</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>AUDIT-C or Drinkers Index (Analysis II)</title>
        <description>The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.</description>
        <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
        <population>For this study, at-risk drinking was defined as: AUDIT total &gt;=8, under 21 drinker, any past year heavy episodic drinking (HED). Excludes at-risk participants defined as any amount of HED (AUDIT Question 3 &gt; 0) or under 21 drinker at baseline. A total of 281 participants were excluded from this analysis (N = 190)</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
          </group>
          <group group_id="O2">
            <title>SBIRT</title>
            <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
          </group>
        </group_list>
        <measure>
          <title>AUDIT-C or Drinkers Index (Analysis II)</title>
          <description>The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.</description>
          <population>For this study, at-risk drinking was defined as: AUDIT total &gt;=8, under 21 drinker, any past year heavy episodic drinking (HED). Excludes at-risk participants defined as any amount of HED (AUDIT Question 3 &gt; 0) or under 21 drinker at baseline. A total of 281 participants were excluded from this analysis (N = 190)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.42" spread="0.24"/>
                    <measurement group_id="O2" value="4.63" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>=0.023</p_value>
            <p_value_desc>A priori threshold for statistical significance was 0.05.</p_value_desc>
            <method>Repeated Measures--General Linear Model</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis II)</title>
        <description>The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.</description>
        <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
        <population>For this study, at-risk drinking was defined as: AUDIT total &gt;=8, under 21 drinker, any past year heavy episodic drinking (HED). Excludes at-risk participants defined as any amount of HED (AUDIT Question 3 &gt; 0) or under 21 drinker at baseline. A total of 281 participants were excluded from this analysis (N = 190)</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
          </group>
          <group group_id="O2">
            <title>SBIRT</title>
            <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
          </group>
        </group_list>
        <measure>
          <title>Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis II)</title>
          <description>The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.</description>
          <population>For this study, at-risk drinking was defined as: AUDIT total &gt;=8, under 21 drinker, any past year heavy episodic drinking (HED). Excludes at-risk participants defined as any amount of HED (AUDIT Question 3 &gt; 0) or under 21 drinker at baseline. A total of 281 participants were excluded from this analysis (N = 190)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.45" spread="1.55"/>
                    <measurement group_id="O2" value="79.34" spread="1.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A priori threshold for statistical significance was 0.05.</p_value_desc>
            <method>Repeated Measures--General Linear Model</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Readiness to Change Scale (Analysis II)</title>
        <description>A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.</description>
        <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
        <population>For this study, at-risk drinking was defined as: AUDIT total &gt;=8, under 21 drinker, any past year heavy episodic drinking (HED). Excludes at-risk participants defined as any amount of HED (AUDIT Question 3 &gt; 0) or under 21 drinker at baseline. A total of 281 participants were excluded from this analysis (N = 190)</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
          </group>
          <group group_id="O2">
            <title>SBIRT</title>
            <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
          </group>
        </group_list>
        <measure>
          <title>Readiness to Change Scale (Analysis II)</title>
          <description>A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.</description>
          <population>For this study, at-risk drinking was defined as: AUDIT total &gt;=8, under 21 drinker, any past year heavy episodic drinking (HED). Excludes at-risk participants defined as any amount of HED (AUDIT Question 3 &gt; 0) or under 21 drinker at baseline. A total of 281 participants were excluded from this analysis (N = 190)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.29" spread="0.13"/>
                    <measurement group_id="O2" value="2.46" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>=0.348</p_value>
            <p_value_desc>A priori threshold for statistical significance was 0.05.</p_value_desc>
            <method>Repeated Measures--General Linear Model</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis III--complete Cases)</title>
        <description>The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.</description>
        <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
        <population>Complete case analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
          </group>
          <group group_id="O2">
            <title>SBIRT</title>
            <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis III--complete Cases)</title>
          <description>The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.</description>
          <population>Complete case analysis</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="244"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.87" spread="0.25"/>
                    <measurement group_id="O2" value="5.48" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.091</p_value>
            <p_value_desc>A priori threshold for statistical significance was 0.05.</p_value_desc>
            <method>Repeated Measures GLM</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>.345</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>.203</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>AUDIT-C or Drinkers Index (Analysis III Complete Cases)</title>
        <description>The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.</description>
        <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
        <population>Complete case analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
          </group>
          <group group_id="O2">
            <title>SBIRT</title>
            <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
          </group>
        </group_list>
        <measure>
          <title>AUDIT-C or Drinkers Index (Analysis III Complete Cases)</title>
          <description>The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.</description>
          <population>Complete case analysis</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="244"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread=".14"/>
                    <measurement group_id="O2" value="4.05" spread=".15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.278</p_value>
            <p_value_desc>A priori alpha set at 0.05</p_value_desc>
            <method>Repeated Measures GLM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>.393</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>.362</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis III Complete Cases)</title>
        <description>The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.</description>
        <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
        <population>Complete case analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
          </group>
          <group group_id="O2">
            <title>SBIRT</title>
            <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
          </group>
        </group_list>
        <measure>
          <title>Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis III Complete Cases)</title>
          <description>The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.</description>
          <population>Complete case analysis</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="244"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.66" spread="1.0"/>
                    <measurement group_id="O2" value="81.82" spread="1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.029</p_value>
            <p_value_desc>A priori alpha set at 0.05.</p_value_desc>
            <method>Repeated Measures GLM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>3.163</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.44</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Readiness to Change Scale (Analysis III Complete Cases)</title>
        <description>A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.</description>
        <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
        <population>Complete case analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
          </group>
          <group group_id="O2">
            <title>SBIRT</title>
            <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
          </group>
        </group_list>
        <measure>
          <title>Readiness to Change Scale (Analysis III Complete Cases)</title>
          <description>A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.</description>
          <population>Complete case analysis</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="238"/>
                <count group_id="O2" value="221"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.21" spread="0.08"/>
                    <measurement group_id="O2" value="2.20" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.897</p_value>
            <p_value_desc>A priori alpha set at 0.05.</p_value_desc>
            <method>Repeated Measures GLM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.015</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis IV--Multiple Imputation and Intention to Treat Analysis)</title>
        <description>The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.</description>
        <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
        <population>Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791)</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
          </group>
          <group group_id="O2">
            <title>SBIRT</title>
            <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis IV--Multiple Imputation and Intention to Treat Analysis)</title>
          <description>The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.</description>
          <population>Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="403"/>
                <count group_id="O2" value="388"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.47" spread="0.16"/>
                    <measurement group_id="O2" value="4.15" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.15</p_value>
            <method>Linear mixed effects</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>AUDIT-C or Drinkers Index (Analysis IV--Intent to Treat Analyses)</title>
        <description>The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.</description>
        <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
        <population>Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791)</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
          </group>
          <group group_id="O2">
            <title>SBIRT</title>
            <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
          </group>
        </group_list>
        <measure>
          <title>AUDIT-C or Drinkers Index (Analysis IV--Intent to Treat Analyses)</title>
          <description>The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.</description>
          <population>Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="403"/>
                <count group_id="O2" value="388"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.95" spread="0.21"/>
                    <measurement group_id="O2" value="5.62" spread="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.20</p_value>
            <p_value_desc>A priori alpha set at 0.05.</p_value_desc>
            <method>Linear mixed effects</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis IV--Intent to Treat Analyses)</title>
        <description>The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.</description>
        <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
        <population>Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791)</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
          </group>
          <group group_id="O2">
            <title>SBIRT</title>
            <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
          </group>
        </group_list>
        <measure>
          <title>Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis IV--Intent to Treat Analyses)</title>
          <description>The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.</description>
          <population>Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="403"/>
                <count group_id="O2" value="388"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.42" spread="0.85"/>
                    <measurement group_id="O2" value="81.30" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.38</p_value>
            <p_value_desc>A priori alpha set at 0.05.</p_value_desc>
            <method>Linear mixed effects</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Readiness to Change Scale (Analysis IV--Multiple Imputation and Intention to Treat Analysis)</title>
        <description>A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.</description>
        <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
          </group>
          <group group_id="O2">
            <title>SBIRT</title>
            <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
          </group>
        </group_list>
        <measure>
          <title>Readiness to Change Scale (Analysis IV--Multiple Imputation and Intention to Treat Analysis)</title>
          <description>A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="403"/>
                <count group_id="O2" value="388"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.22" spread="0.07"/>
                    <measurement group_id="O2" value="2.16" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A priori alpha set at 0.05</non_inferiority_desc>
            <p_value>0.48</p_value>
            <method>Linear mixed effects</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis V--Multiple Imputation and Intention to Treat Analysis)</title>
        <description>The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.</description>
        <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
        <population>Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
          </group>
          <group group_id="O2">
            <title>SBIRT</title>
            <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis V--Multiple Imputation and Intention to Treat Analysis)</title>
          <description>The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.</description>
          <population>Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="166"/>
                <count group_id="O2" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.38" spread="0.25"/>
                    <measurement group_id="O2" value="4.85" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A priori alpha set at 0.05.</non_inferiority_desc>
            <p_value>0.09</p_value>
            <method>Linear mixed effects</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>AUDIT-C or Drinkers Index (Analysis V--Intent to Treat Analyses)</title>
        <description>The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.</description>
        <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
        <population>Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
          </group>
          <group group_id="O2">
            <title>SBIRT</title>
            <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
          </group>
        </group_list>
        <measure>
          <title>AUDIT-C or Drinkers Index (Analysis V--Intent to Treat Analyses)</title>
          <description>The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.</description>
          <population>Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="166"/>
                <count group_id="O2" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.09" spread="0.39"/>
                    <measurement group_id="O2" value="7.64" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A priori alpha set at 0.05</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.08</p_value>
            <method>Linear mixed effects</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis V--Intent to Treat Analyses)</title>
        <description>The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.</description>
        <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
        <population>Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
          </group>
          <group group_id="O2">
            <title>SBIRT</title>
            <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
          </group>
        </group_list>
        <measure>
          <title>Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis V--Intent to Treat Analyses)</title>
          <description>The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.</description>
          <population>Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="166"/>
                <count group_id="O2" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.18" spread="1.38"/>
                    <measurement group_id="O2" value="77.84" spread="1.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A priori alpha set at 0.05</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.11</p_value>
            <method>Linear mixed effects</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Readiness to Change Scale (Analysis V--Multiple Imputation and Intention to Treat Analysis)</title>
        <description>A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.</description>
        <time_frame>Baseline, Follow-up (Up to 7 months)</time_frame>
        <population>Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
          </group>
          <group group_id="O2">
            <title>SBIRT</title>
            <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
          </group>
        </group_list>
        <measure>
          <title>Readiness to Change Scale (Analysis V--Multiple Imputation and Intention to Treat Analysis)</title>
          <description>A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.</description>
          <population>Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="166"/>
                <count group_id="O2" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.33" spread="0.10"/>
                    <measurement group_id="O2" value="2.35" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A priori alpha set at 0.05</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.84</p_value>
            <method>Linear mixed effects</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Usual Care</title>
          <description>Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.</description>
        </group>
        <group group_id="E2">
          <title>SBIRT</title>
          <description>Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:&#xD;
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.&#xD;
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.&#xD;
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.&#xD;
SBIRT: SBIRT is an &quot;opportunistic&quot; approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a &quot;teachable moment,&quot; are delivered a brief, motivational intervention matched to their level of risk.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="244"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="228"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="244"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="228"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Mark B. Reed/Professor and Interim Associate Dean</name_or_title>
      <organization>San Diego State University Research Foundation</organization>
      <phone>619-594-6664</phone>
      <email>mreed@sdsu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02228967
org study id: W81XWH-14-2-0014
secondary id: 12019006
nct id: NCT02228967
lead sponsor: 
collaborator: 
has dmc: No
An alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) approach will be
      adapted for use in a large military hospital setting, and then pilot tested in a military
      emergency department (ED) to assess its potential for effectiveness and for further testing
      in a large-scale trial. SBIRT is an "opportunistic" approach whereby all adult patients in
      the ED are screened by Health Educators for their alcohol use, and then, taking advantage of
      a "teachable moment," are delivered a brief, motivational intervention matched to their level
      of risk.

      The feasibility/formative research activities in the first phase (Phase I) of the study are
      not summative research, and therefore, do not lend themselves to testable hypotheses.
      Hypotheses with regard to the pilot randomized trial in Phase II are as follows:

        1. Participants in the SBIRT intervention will show relatively greater reductions over a
           six month period (or less increase) than the brochure/usual care control group in the
           prevalence of past-month heavy drinking, frequency of heavy drinking, past week number
           of drinks, and the AUDIT-based drinkers' index.

        2. Alcohol use-related motivation/readiness to change and controlled drinking self-efficacy
           will show greater change in the SBIRT intervention group relative to the brochure/usual
           care control group.

           In addition, exploratory analyses will examine the following:

        3. Sociodemographic/military variables (e.g., age, race/ethnicity, gender, branch of
           service, officer/enlisted status, PTS) and social-psychological factors (e.g., baseline
           readiness to change, self efficacy) will mediate or moderate changes in alcohol misuse.
Deployment frequency and duration and combat exposure are implicated as risk factors for
      alcohol misuse and PTSD among military personnel. During the past 10 years, Department of
      Defense healthcare systems have observed steep increases in mental health and substance use
      services among personnel demobilizing from these conflicts. Although the alcohol Screening,
      Brief Intervention and Referral to Treatment (SBIRT) approach has shown promise as a
      low-cost, effective strategy for reducing alcohol use in civilians many of whom are risky
      drinkers but not yet dependent, it has not been adapted or tested in military health care
      settings for active duty personnel. This 2.5 year civilian-military collaborative study is
      highly responsive to exploring solutions to this emerging issue. The specific objectives for
      the overall project are given below.

      Objective 1: Feasibility and Acceptability

        -  Determine how the SBIRT intervention can be integrated into standard military emergency
           department (ED) operations by conducting record review and observation of the ED.

        -  Develop and test the acceptability and usability (for both ED staff and potential
           participants) of the SBIRT approach by conducting focus groups with active duty
           personnel and garnering input from ED staff.

        -  Develop an implementation/operations protocol for delivering SBIRT in the ED.

      Objective 2: Adaptation

        -  Apply a translational research approach to adapt SBIRT implementation in military
           settings and populations by using information from focus groups and input from ED staff.

        -  Adapt the content of the SBIRT intervention to be relevant for military personnel,
           including language and images for counseling and materials using information from focus
           groups and input from ED staff.

      Objective 3: Pilot Trial

        -  Using a two group repeated measures design, assess the impact of SBIRT using
           standardized alcohol use measures to assess its potential for effectiveness with active
           duty military personnel in an ED setting. Specific methodologies include:

        -  Apply a randomization method in the ED to assign active duty participants to
           experimental condition.

        -  Implement the SBIRT intervention in the ED for those assigned to the intervention arm.

        -  Implement a process for obtaining follow-up data with this mobile population.

        -  Assess presumed mediators (e.g., readiness/motivation to change and self-efficacy) and
           moderators (e.g., PTSD status, gender) of alcohol misuse change.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Alcohol Use Disorders Identification Test (AUDIT) Total
time frame: Baseline, Follow-up (Up to 7 months)
description: The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.
measure: AUDIT-C or Drinkers Index
time frame: Baseline, Follow-up (Up to 7 months)
description: The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.
measure: Controlled Drinking Self-Efficacy Scale (CDSES)
time frame: Baseline, Follow-up (Up to 7 months)
description: The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.
measure: Readiness to Change Scale
time frame: Baseline, Follow-up (Up to 7 months)
description: A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.
arm group label: Usual Care
arm group type: No Intervention
description: Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.
arm group label: SBIRT
arm group type: Active Comparator
description: Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:
Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.
Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.
Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.
intervention type: Behavioral
intervention name: SBIRT
description: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
arm group label: SBIRT
other name: Screening
other name: Brief Intervention
other name: Brief Treatment
other name: Referral to Treatment
other name: Motivational Interviewing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mark Reed, PhD
role: Principal Investigator
affiliation: SDSURF - Center for Alcohol & Drug Studies & Services
last name: Gerard DeMers, DO
role: Principal Investigator
affiliation: United States Naval Medical Center, San Diego
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: San Diego State University
investigator full name: Mark Reed, PhD
investigator title: Director
mesh term: Alcoholism
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 