<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/NCT02233946</url>
  </required_header>
  <id_info>
    <org_study_id>P00004862</org_study_id>
    <secondary_id>1R01AA021904-01</secondary_id>
    <nct_id>NCT02233946</nct_id>
  </id_info>
  <brief_title>Computerized Alcohol Screening for Children and Adolescents (cASCA) in Primary Care</brief_title>
  <acronym>cASCA</acronym>
  <official_title>Computerized Alcohol Screening for Children and Adolescents (cASCA) in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the psychometric properties of a brief screening&#xD;
      questionnaire for alcohol problems among 9- to 18-year-old patients in pediatricians'&#xD;
      offices, and to pilot test a personalized, computer-facilitated brief intervention delivered&#xD;
      on a tablet computer and by the provider based on screening results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary goal of this project is to develop a computerized screening program for primary&#xD;
      care offices that is based on the NIAAA's new Alcohol Screening Guide for Children and&#xD;
      Adolescents and assess its psychometric properties among nine- to 18-yr-old primary care&#xD;
      patients. There is substantial evidence supporting the effectiveness of screening and brief&#xD;
      intervention among adult primary care patients, primarily in the reduction of harmful&#xD;
      drinking. However, there have been few studies of alcohol screening and brief intervention&#xD;
      conducted among adolescents seen in busy primary care settings. This project will develop and&#xD;
      validate a new computerized Alcohol Screening for Children and Adolescents (cASCA) program&#xD;
      which incorporates the age-specific screening questions of the NIAAA Guide and includes the&#xD;
      CRAFFT and AUDIT as secondary risk/problem assessments. We will add tobacco screening because&#xD;
      tobacco use is the leading cause of cancer-related mortality in the US as well as screening&#xD;
      for marijuana and other drug use so as to create a comprehensive screening instrument that&#xD;
      includes all major substances that adolescents use.&#xD;
&#xD;
      Additionally, the NIAAA guide recommends that providers deliver a brief intervention in&#xD;
      response to the screening results. Therefore, a secondary aim of this project will be to&#xD;
      pilot-test a computer-facilitated Brief Intervention component using a randomized design&#xD;
      comparing three groups: 1) screening with treatment as usual [cASCA/TAU]; 2) screening with&#xD;
      the computer-facilitated brief intervention [cASCA/BI]. The BI component consists of patients&#xD;
      viewing on the computer, immediately after the screening, their score and level of risk for a&#xD;
      substance use problem, as well as several interactive pages of science and true-life stories&#xD;
      about the health risks of substance use. Clinicians are then given the screen results and&#xD;
      suggested talking points for a few minutes of brief counseling during the visit.&#xD;
&#xD;
      Hypothesis: Among 9- to 18-year-old primary care patients, those receiving cASCA/BI will have&#xD;
      lower rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of&#xD;
      heavy episodic drinking, at 3, 6, 9 and 12-months follow-up than those receiving treatment as&#xD;
      usual.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to First Post-visit Drinking Day</measure>
    <time_frame>12-months follow-up</time_frame>
    <description>Median (and interquartile range) for times to first use for the cSBI and Treatment As Usual (TAU) groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to First Post-visit Heavy Episodic Drinking Day</measure>
    <time_frame>12-months follow-up</time_frame>
    <description>The number of days post-visit to first reported heavy episodic drinking day</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to First Post-visit Cannabis Use Day</measure>
    <time_frame>12-months follow-up</time_frame>
    <description>The number of days post-visit to first reported cannabis use day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Past-3-month Riding Risk</measure>
    <time_frame>12 months follow-up</time_frame>
    <description>Self-reported riding in the past 3 months with a driver who had been drinking or using other drugs, stratified by reported riding risk in the past 3 months at baseline</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">871</enrollment>
  <condition>Prevention Harmful Effects</condition>
  <arm_group>
    <arm_group_label>screening w/ computer brief intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>screening with computer-facilitated brief intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Screening with Treatment as Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Screening with Treatment as Usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>computer-facilitated brief intervention</intervention_name>
    <description>Immediate feedback to patient of screening results and risk for substance use problem, followed by 11 pages of science and true-life stories about health risks of adolescent substance use. Screening results then go to provider who reviews them with patient and gives brief counseling, and refers to an online motivational enhancement therapy intervention for patients at moderate/high risk for substance use problems.</description>
    <arm_group_label>screening w/ computer brief intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  access to computer and email address&#xD;
&#xD;
          -  available and willing to complete all follow ups by email or phone&#xD;
&#xD;
          -  medically and emotionally stable&#xD;
&#xD;
          -  can read and understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has already participated in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John R Knight, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sion K Harris, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Childrens Primary Care Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Longwood Pediatrics</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Boston Neighborhood Health Center</name>
      <address>
        <city>East Boston</city>
        <state>Massachusetts</state>
        <zip>02128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexington Pediatrics</name>
      <address>
        <city>Lexington</city>
        <state>Massachusetts</state>
        <zip>02421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.ceasar.org</url>
    <description>Center for Adolescent Substance Abuse Research</description>
  </link>
  <reference>
    <citation>Harris SK, Csemy L, Sherritt L, Starostova O, Van Hook S, Johnson J, Boulter S, Brooks T, Carey P, Kossack R, Kulig JW, Van Vranken N, Knight JR. Computer-facilitated substance use screening and brief advice for teens in primary care: an international trial. Pediatrics. 2012 Jun;129(6):1072-82. doi: 10.1542/peds.2011-1624. Epub 2012 May 7.</citation>
    <PMID>22566420</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>December 28, 2020</results_first_submitted>
  <results_first_submitted_qc>February 18, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 11, 2021</results_first_posted>
  <last_update_submitted>February 18, 2021</last_update_submitted>
  <last_update_submitted_qc>February 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Sion Kim Harris</investigator_full_name>
    <investigator_title>Co-Director, Center for Adolescent Substance Abuse Research</investigator_title>
  </responsible_party>
  <keyword>Substance Abuse</keyword>
  <keyword>Prevention</keyword>
  <keyword>Youth</keyword>
  <keyword>Alcohol</keyword>
  <keyword>Drugs</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/46/NCT02233946/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Computerized Screening w/ Provider Brief Intervention (cSBI)</title>
          <description>cSBI consists of adolescents self-administering on a tablet computer a screening questionnaire prior to seeing their provider. The computer program then immediately provides adolescents with personalized feedback, followed by brief psychoeducation illustrating the health-related risks of substance use. Providers then login to the tablet computer to access a Clinician Report Form which presents the patient's screening results, as well as discussion prompts to guide a few minutes of Motivational Interviewing-based brief counseling during the visit.</description>
        </group>
        <group group_id="P2">
          <title>Computerized Screening With Treatment as Usual (TAU)</title>
          <description>The comparison group also completed the computerized screening tool. However, this group did not receive any feedback or psychoeducation, and their providers did not receive the screening results. During the visit, adolescents in this group received treatment as usual.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Baseline</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="628">Allocated to and received the intervention</participants>
                <participants group_id="P2" count="243">Allocated to and received usual care</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="626">Completed baseline assessment</participants>
                <participants group_id="P2" count="243">Completed baseline assessment</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Immediate Post-visit Questionnaire</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="626"/>
                <participants group_id="P2" count="243"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="624"/>
                <participants group_id="P2" count="243"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>3-months Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="624"/>
                <participants group_id="P2" count="243"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="571"/>
                <participants group_id="P2" count="214"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="29"/>
              </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="53"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>6-months Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="571"/>
                <participants group_id="P2" count="214"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="550"/>
                <participants group_id="P2" count="212"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="2"/>
              </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="21"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>9-month Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="550"/>
                <participants group_id="P2" count="212"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="530"/>
                <participants group_id="P2" count="201"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="11"/>
              </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="20"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>12-month Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="530"/>
                <participants group_id="P2" count="201"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="502"/>
                <participants group_id="P2" count="190"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="11"/>
              </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="28"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>12- to 18-year-olds arriving for their annual well-visit at participating pediatric practices</population>
      <group_list>
        <group group_id="B1">
          <title>Computerized Screening w/ Provider Brief Intervention (cSBI)</title>
          <description>cSBI consists of adolescents self-administering on a tablet computer a screening questionnaire prior to seeing their provider. The computer program then immediately provides adolescents with personalized feedback, followed by brief psychoeducation illustrating the health-related risks of substance use. Providers then login to the tablet computer to access a Clinician Report Form which presents the patient's screening results, as well as discussion prompts to guide a few minutes of Motivational Interviewing-based brief counseling during the visit.</description>
        </group>
        <group group_id="B2">
          <title>Computerized Screening With Treatment as Usual (TAU)</title>
          <description>The comparison group also completed the computerized screening tool. However, this group did not receive any feedback or psychoeducation, and their providers did not receive the screening results. During the visit, adolescents in this group received treatment as usual.</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="626"/>
            <count group_id="B2" value="243"/>
            <count group_id="B3" value="869"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Participants who reported past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="148"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.3" spread="1.3"/>
                    <measurement group_id="B2" value="16.5" spread="1.3"/>
                    <measurement group_id="B3" value="16.4" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who reported no past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="180"/>
                    <count group_id="B3" value="658"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.1" spread="1.8"/>
                    <measurement group_id="B2" value="14.5" spread="1.7"/>
                    <measurement group_id="B3" value="14.3" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Participants who reported past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="148"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who reported no past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="180"/>
                    <count group_id="B3" value="658"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="236"/>
                    <measurement group_id="B2" value="91"/>
                    <measurement group_id="B3" value="327"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="242"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="331"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <population>We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Participants who reported past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="148"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Non-Hispanic White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="105"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other or multirace</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who reported no past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="180"/>
                    <count group_id="B3" value="658"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Non-Hispanic White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="203"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="282"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="143"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="201"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other or multirace</title>
                  <measurement_list>
                    <measurement group_id="B1" value="132"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="626"/>
                    <count group_id="B2" value="243"/>
                    <count group_id="B3" value="869"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="626"/>
                    <measurement group_id="B2" value="243"/>
                    <measurement group_id="B3" value="869"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>In grades 9-12</title>
          <population>We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Participants who reported past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="148"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="141"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="201"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who reported no past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="180"/>
                    <count group_id="B3" value="658"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="197"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="297"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="281"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="361"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lives with two parents in home</title>
          <population>We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Participants who reported past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="148"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="144"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who reported no past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="180"/>
                    <count group_id="B3" value="658"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="380"/>
                    <measurement group_id="B2" value="143"/>
                    <measurement group_id="B3" value="523"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parent highest education level is college graduate or higher</title>
          <population>We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Participants who reported past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="148"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="144"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who reported no past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="180"/>
                    <count group_id="B3" value="658"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="306"/>
                    <measurement group_id="B2" value="108"/>
                    <measurement group_id="B3" value="414"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="172"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="244"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Saw a pediatrician at visit</title>
          <population>We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Participants who reported past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="148"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="128"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="178"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who reported no past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="180"/>
                    <count group_id="B3" value="658"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="412"/>
                    <measurement group_id="B2" value="152"/>
                    <measurement group_id="B3" value="564"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Saw a female practitioner</title>
          <population>We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Participants who reported past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="148"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="99"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="149"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who reported no past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="180"/>
                    <count group_id="B3" value="658"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="321"/>
                    <measurement group_id="B2" value="117"/>
                    <measurement group_id="B3" value="438"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="157"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="220"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Had 6 or more prior visits with practitioner</title>
          <population>We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Participants who reported past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="148"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="123"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who reported no past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="180"/>
                    <count group_id="B3" value="658"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="284"/>
                    <measurement group_id="B2" value="106"/>
                    <measurement group_id="B3" value="390"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="194"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="268"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Had CRAFFT score of 2 or greater</title>
          <description>Score of &gt;=2 suggests a serious problem and warrants clinical attention. C-Have you ever ridden in a CAR driven by someone (including yourself) who was &quot;high&quot; or had been using alcohol or drugs? R-Do you ever use alcohol or drugs to RELAX, feel better about yourself, or fit in? A-Do you ever use alcohol or drugs while you are by yourself, or ALONE? F-Do you ever FORGET things you did while using alcohol or drugs? F-Do your family or FRIENDS ever tell you that you should cut down on your drinking or drug use? T-Have you ever gotten into TROUBLE while you were using alcohol or drugs?</description>
          <population>Participants who reported past-12-month use of alcohol or other drugs at baseline</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="148"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="148"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hung out with friends who use alcohol/drugs</title>
          <population>We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Participants who reported past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="148"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="188"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who reported no past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="180"/>
                    <count group_id="B3" value="658"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="169"/>
                    <measurement group_id="B2" value="82"/>
                    <measurement group_id="B3" value="251"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="309"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="407"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Has substance-involved siblings</title>
          <population>We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Participants who reported past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="148"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who reported no past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="180"/>
                    <count group_id="B3" value="658"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="438"/>
                    <measurement group_id="B2" value="170"/>
                    <measurement group_id="B3" value="608"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Has substance-involved parents/guardians</title>
          <population>We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Participants who reported past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="148"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who reported no past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="180"/>
                    <count group_id="B3" value="658"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="451"/>
                    <measurement group_id="B2" value="172"/>
                    <measurement group_id="B3" value="623"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time to First Post-visit Drinking Day</title>
        <description>Median (and interquartile range) for times to first use for the cSBI and Treatment As Usual (TAU) groups</description>
        <time_frame>12-months follow-up</time_frame>
        <population>Stratified: Participants who reported past-12-month use of alcohol or other drugs at baseline vs. Participants who reported no past-12-month use of alcohol or other drugs at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Computerized Screening w/ Provider Brief Intervention (cSBI)</title>
            <description>cSBI consists of adolescents self-administering on a tablet computer a screening questionnaire prior to seeing their provider. The computer program then immediately provides adolescents with personalized feedback, followed by brief psychoeducation illustrating the health-related risks of substance use. Providers then login to the tablet computer to access a Clinician Report Form which presents the patient's screening results, as well as discussion prompts to guide a few minutes of Motivational Interviewing-based brief counseling during the visit.</description>
          </group>
          <group group_id="O2">
            <title>Computerized Screening With Treatment as Usual (TAU)</title>
            <description>The comparison group also completed the computerized screening tool. However, this group did not receive any feedback or psychoeducation, and their providers did not receive the screening results. During the visit, adolescents in this group received treatment as usual.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Post-visit Drinking Day</title>
          <description>Median (and interquartile range) for times to first use for the cSBI and Treatment As Usual (TAU) groups</description>
          <population>Stratified: Participants who reported past-12-month use of alcohol or other drugs at baseline vs. Participants who reported no past-12-month use of alcohol or other drugs at baseline</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="570"/>
                <count group_id="O2" value="212"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants who reported past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97" lower_limit="51" upper_limit="222"/>
                    <measurement group_id="O2" value="44" lower_limit="21" upper_limit="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who reported no past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="456"/>
                    <count group_id="O2" value="166"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="366" lower_limit="338" upper_limit="366"/>
                    <measurement group_id="O2" value="366" lower_limit="334" upper_limit="366"/>
                  </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>Participants who reported past-12-month use of alcohol or other drugs at baseline</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Cox Proportional Hazard</param_type>
            <param_value>0.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.47</ci_lower_limit>
            <ci_upper_limit>1.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Participants who reported no past-12-month use of alcohol or other drugs at baseline</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Cox Proportional Hazard</param_type>
            <param_value>0.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.57</ci_lower_limit>
            <ci_upper_limit>1.31</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to First Post-visit Heavy Episodic Drinking Day</title>
        <description>The number of days post-visit to first reported heavy episodic drinking day</description>
        <time_frame>12-months follow-up</time_frame>
        <population>Participants who reported past-12-month use of alcohol or other drugs at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Computerized Screening w/ Provider Brief Intervention (cSBI)</title>
            <description>cSBI consists of adolescents self-administering on a tablet computer a screening questionnaire prior to seeing their provider. The computer program then immediately provides adolescents with personalized feedback, followed by brief psychoeducation illustrating the health-related risks of substance use. Providers then login to the tablet computer to access a Clinician Report Form which presents the patient's screening results, as well as discussion prompts to guide a few minutes of Motivational Interviewing-based brief counseling during the visit.</description>
          </group>
          <group group_id="O2">
            <title>Computerized Screening With Treatment as Usual (TAU)</title>
            <description>The comparison group also completed the computerized screening tool. However, this group did not receive any feedback or psychoeducation, and their providers did not receive the screening results. During the visit, adolescents in this group received treatment as usual.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Post-visit Heavy Episodic Drinking Day</title>
          <description>The number of days post-visit to first reported heavy episodic drinking day</description>
          <population>Participants who reported past-12-month use of alcohol or other drugs at baseline</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="366" lower_limit="124" upper_limit="366"/>
                    <measurement group_id="O2" value="213" lower_limit="51" upper_limit="366"/>
                  </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>Participants who reported past-12-month use of alcohol or other drugs at baseline</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Cox Proportional Hazard</param_type>
            <param_value>0.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.40</ci_lower_limit>
            <ci_upper_limit>1.10</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Post-visit Cannabis Use Day</title>
        <description>The number of days post-visit to first reported cannabis use day.</description>
        <time_frame>12-months follow-up</time_frame>
        <population>Stratified: Participants who reported past-12-month use of alcohol or other drugs at baseline vs. Participants who reported no past-12-month use of alcohol or other drugs at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Computerized Screening w/ Provider Brief Intervention (cSBI)</title>
            <description>cSBI consists of adolescents self-administering on a tablet computer a screening questionnaire prior to seeing their provider. The computer program then immediately provides adolescents with personalized feedback, followed by brief psychoeducation illustrating the health-related risks of substance use. Providers then login to the tablet computer to access a Clinician Report Form which presents the patient's screening results, as well as discussion prompts to guide a few minutes of Motivational Interviewing-based brief counseling during the visit.</description>
          </group>
          <group group_id="O2">
            <title>Computerized Screening With Treatment as Usual (TAU)</title>
            <description>The comparison group also completed the computerized screening tool. However, this group did not receive any feedback or psychoeducation, and their providers did not receive the screening results. During the visit, adolescents in this group received treatment as usual.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Post-visit Cannabis Use Day</title>
          <description>The number of days post-visit to first reported cannabis use day.</description>
          <population>Stratified: Participants who reported past-12-month use of alcohol or other drugs at baseline vs. Participants who reported no past-12-month use of alcohol or other drugs at baseline</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="516"/>
                <count group_id="O2" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants who reported past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101" lower_limit="33" upper_limit="226"/>
                    <measurement group_id="O2" value="83" lower_limit="27" upper_limit="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who reported no past-12-month use of alcohol or other drugs at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="456"/>
                    <count group_id="O2" value="166"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="366" lower_limit="366" upper_limit="366"/>
                    <measurement group_id="O2" value="366" lower_limit="366" upper_limit="366"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Participants who reported past-12-month use of alcohol or other drugs at baseline</non_inferiority_desc>
            <param_type>Cox Proportional Hazard</param_type>
            <param_value>0.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.41</ci_lower_limit>
            <ci_upper_limit>0.94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Participants who reported no past-12-month use of alcohol or other drugs at baseline</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Cox Proportional Hazard</param_type>
            <param_value>0.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.44</ci_lower_limit>
            <ci_upper_limit>1.32</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Past-3-month Riding Risk</title>
        <description>Self-reported riding in the past 3 months with a driver who had been drinking or using other drugs, stratified by reported riding risk in the past 3 months at baseline</description>
        <time_frame>12 months follow-up</time_frame>
        <population>Participants with riding risk at baseline vs. those with no riding risk at baseline. (Differences in number of participants analyzed at each follow-up time point is due to number of survey respondents at that time point. For example, in the cSBI group at baseline, 64 participants reported having riding risk. At 3 months follow-up, 44 of those completed a survey, and 20 of those 44 reported having riding risk at the 3-months follow-up.)</population>
        <group_list>
          <group group_id="O1">
            <title>Computerized Screening w/ Provider Brief Intervention (cSBI)</title>
            <description>cSBI consists of adolescents self-administering on a tablet computer a screening questionnaire prior to seeing their provider. The computer program then immediately provides adolescents with personalized feedback, followed by brief psychoeducation illustrating the health-related risks of substance use. Providers then login to the tablet computer to access a Clinician Report Form which presents the patient's screening results, as well as discussion prompts to guide a few minutes of Motivational Interviewing-based brief counseling during the visit.</description>
          </group>
          <group group_id="O2">
            <title>Computerized Screening With Treatment as Usual (TAU)</title>
            <description>The comparison group also completed the computerized screening tool. However, this group did not receive any feedback or psychoeducation, and their providers did not receive the screening results. During the visit, adolescents in this group received treatment as usual.</description>
          </group>
        </group_list>
        <measure>
          <title>Past-3-month Riding Risk</title>
          <description>Self-reported riding in the past 3 months with a driver who had been drinking or using other drugs, stratified by reported riding risk in the past 3 months at baseline</description>
          <population>Participants with riding risk at baseline vs. those with no riding risk at baseline. (Differences in number of participants analyzed at each follow-up time point is due to number of survey respondents at that time point. For example, in the cSBI group at baseline, 64 participants reported having riding risk. At 3 months follow-up, 44 of those completed a survey, and 20 of those 44 reported having riding risk at the 3-months follow-up.)</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="625"/>
                <count group_id="O2" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Riding risk at baseline : Baseline, No.</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Riding risk at baseline : 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Riding risk at baseline : 9 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Riding risk at baseline : 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No riding risk at baseline : Baseline, No.</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="561"/>
                    <count group_id="O2" value="208"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="561"/>
                    <measurement group_id="O2" value="208"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No riding risk at baseline : 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="429"/>
                    <count group_id="O2" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No riding risk at baseline : 9 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="419"/>
                    <count group_id="O2" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No riding risk at baseline : 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="452"/>
                    <count group_id="O2" value="168"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="11"/>
                  </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>Participants with riding risk at baseline:&#xD;
Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 6 months follow-up, cSBI vs. TAU.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.50</ci_lower_limit>
            <ci_upper_limit>1.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Participants with riding risk at baseline:&#xD;
Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 9 months follow-up, cSBI vs. TAU.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.44</ci_lower_limit>
            <ci_upper_limit>1.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Participants with riding risk at baseline:&#xD;
Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 12 months follow-up, cSBI vs. TAU.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.37</ci_lower_limit>
            <ci_upper_limit>0.91</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Participants with no riding risk at baseline:&#xD;
Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 6 months follow-up, cSBI vs. TAU.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.43</ci_lower_limit>
            <ci_upper_limit>1.23</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Participants with no riding risk at baseline:&#xD;
Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 9 months follow-up, cSBI vs. TAU.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>2.66</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Participants with no riding risk at baseline:&#xD;
Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 12 months follow-up, cSBI vs. TAU.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.50</ci_lower_limit>
            <ci_upper_limit>1.99</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Computerized Screening w/ Provider Brief Intervention (cSBI)</title>
          <description>cSBI consists of adolescents self-administering on a tablet computer a screening questionnaire prior to seeing their provider. The computer program then immediately provides adolescents with personalized feedback, followed by brief psychoeducation illustrating the health-related risks of substance use. Providers then login to the tablet computer to access a Clinician Report Form which presents the patient's screening results, as well as discussion prompts to guide a few minutes of Motivational Interviewing-based brief counseling during the visit.</description>
        </group>
        <group group_id="E2">
          <title>Computerized Screening With Treatment as Usual (TAU)</title>
          <description>The comparison group also completed the computerized screening tool. However, this group did not receive any feedback or psychoeducation, and their providers did not receive the screening results. During the visit, adolescents in this group received treatment as usual.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="626"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="243"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="626"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="243"/>
              </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="626"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="243"/>
              </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>
    <limitations_and_caveats>Same practitioners delivering both the CSBI and UC may have contaminated UC arm; only group difference we could assure was the CRAFFT screen. Relied on patients' reporting of intervention; did not obtain independent observations of practitioner behaviors. Relied on self-report. Unable to examine effects on use of certain drugs (low prevalence). Did not collect parents' views of CSBI system.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Sion Kim Harris</name_or_title>
      <organization>Boston Children's Hospital</organization>
      <phone>8572184304</phone>
      <email>sion.harris@childrens.harvard.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/NCT02233946
org study id: P00004862
secondary id: 1R01AA021904-01
nct id: NCT02233946
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to assess the psychometric properties of a brief screening
      questionnaire for alcohol problems among 9- to 18-year-old patients in pediatricians'
      offices, and to pilot test a personalized, computer-facilitated brief intervention delivered
      on a tablet computer and by the provider based on screening results.
The primary goal of this project is to develop a computerized screening program for primary
      care offices that is based on the NIAAA's new Alcohol Screening Guide for Children and
      Adolescents and assess its psychometric properties among nine- to 18-yr-old primary care
      patients. There is substantial evidence supporting the effectiveness of screening and brief
      intervention among adult primary care patients, primarily in the reduction of harmful
      drinking. However, there have been few studies of alcohol screening and brief intervention
      conducted among adolescents seen in busy primary care settings. This project will develop and
      validate a new computerized Alcohol Screening for Children and Adolescents (cASCA) program
      which incorporates the age-specific screening questions of the NIAAA Guide and includes the
      CRAFFT and AUDIT as secondary risk/problem assessments. We will add tobacco screening because
      tobacco use is the leading cause of cancer-related mortality in the US as well as screening
      for marijuana and other drug use so as to create a comprehensive screening instrument that
      includes all major substances that adolescents use.

      Additionally, the NIAAA guide recommends that providers deliver a brief intervention in
      response to the screening results. Therefore, a secondary aim of this project will be to
      pilot-test a computer-facilitated Brief Intervention component using a randomized design
      comparing three groups: 1) screening with treatment as usual [cASCA/TAU]; 2) screening with
      the computer-facilitated brief intervention [cASCA/BI]. The BI component consists of patients
      viewing on the computer, immediately after the screening, their score and level of risk for a
      substance use problem, as well as several interactive pages of science and true-life stories
      about the health risks of substance use. Clinicians are then given the screen results and
      suggested talking points for a few minutes of brief counseling during the visit.

      Hypothesis: Among 9- to 18-year-old primary care patients, those receiving cASCA/BI will have
      lower rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of
      heavy episodic drinking, at 3, 6, 9 and 12-months follow-up than those receiving treatment as
      usual.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Time to First Post-visit Drinking Day
time frame: 12-months follow-up
description: Median (and interquartile range) for times to first use for the cSBI and Treatment As Usual (TAU) groups
measure: Time to First Post-visit Heavy Episodic Drinking Day
time frame: 12-months follow-up
description: The number of days post-visit to first reported heavy episodic drinking day
measure: Time to First Post-visit Cannabis Use Day
time frame: 12-months follow-up
description: The number of days post-visit to first reported cannabis use day.
measure: Past-3-month Riding Risk
time frame: 12 months follow-up
description: Self-reported riding in the past 3 months with a driver who had been drinking or using other drugs, stratified by reported riding risk in the past 3 months at baseline
arm group label: screening w/ computer brief intervention
arm group type: Experimental
description: screening with computer-facilitated brief intervention
arm group label: Screening with Treatment as Usual
arm group type: No Intervention
description: Screening with Treatment as Usual
intervention type: Behavioral
intervention name: computer-facilitated brief intervention
description: Immediate feedback to patient of screening results and risk for substance use problem, followed by 11 pages of science and true-life stories about health risks of adolescent substance use. Screening results then go to provider who reviews them with patient and gives brief counseling, and refers to an online motivational enhancement therapy intervention for patients at moderate/high risk for substance use problems.
arm group label: screening w/ computer brief intervention
criteria: 
gender: All
minimum age: 9 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: John R Knight, MD
role: Principal Investigator
affiliation: Boston Children's Hospital
last name: Sion K Harris, PhD
role: Principal Investigator
affiliation: Boston Children's Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.ceasar.org
description: Center for Adolescent Substance Abuse Research
citation: Harris SK, Csemy L, Sherritt L, Starostova O, Van Hook S, Johnson J, Boulter S, Brooks T, Carey P, Kossack R, Kulig JW, Van Vranken N, Knight JR. Computer-facilitated substance use screening and brief advice for teens in primary care: an international trial. Pediatrics. 2012 Jun;129(6):1072-82. doi: 10.1542/peds.2011-1624. Epub 2012 May 7.
PMID: 22566420
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Sion Kim Harris
investigator title: Co-Director, Center for Adolescent Substance Abuse Research
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Same practitioners delivering both the CSBI and UC may have contaminated UC arm; only group difference we could assure was the CRAFFT screen. Relied on patients' reporting of intervention; did not obtain independent observations of practitioner behaviors. Relied on self-report. Unable to examine effects on use of certain drugs (low prevalence). Did not collect parents' views of CSBI system.
point of contact: 