<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/NCT02247388</url>
  </required_header>
  <id_info>
    <org_study_id>1211011052</org_study_id>
    <secondary_id>R01AA022083-01A1</secondary_id>
    <nct_id>NCT02247388</nct_id>
  </id_info>
  <brief_title>Automated Bilingual Computerized Alcohol Screening and Intervention in Latinos (AB-CASI)</brief_title>
  <acronym>AB-CASI</acronym>
  <official_title>Automated Bilingual Computerized Alcohol Screen and Intervention in Latinos</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</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>Yale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To study the efficacy of AB-CASI against standard of care in a randomized controlled trial in&#xD;
      the Emergency Department.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research team will rigorously test the efficacy of AB-CASI, against a standard condition&#xD;
      (SC) in a first-of-a-kind ED randomized controlled trial. Studying an urban adult (≥ 18 y/o)&#xD;
      Latino ED population, the objectives are to demonstrate the superiority of AB-CASI compared&#xD;
      to SC in: 1) reduction of alcohol consumption (Aims 1), 2) reduction of negative health&#xD;
      behaviors and consequences (Aim 2), and 3) increasing 30-day treatment engagement (Aim 3).&#xD;
      The investigators will also explore variation of the AB-CASI intervention on alcohol&#xD;
      consumption, alcohol-related negative health behaviors and consequences, and 30-day treatment&#xD;
      engagement by Latino subpopulations (Puerto-Rican, Mexican-American, Cuban-American,&#xD;
      South/Central American) as well as other potential modifiers (age, birthplace, gender,&#xD;
      preferred language, reason for ED visit, and smoking status). English and Spanish speaking&#xD;
      Latino adults presenting to the Bridgeport Hospital ED will be screened using the study&#xD;
      inclusion and exclusion criteria.&#xD;
&#xD;
      In March 2020, the primary and secondary outcomes were corrected to reflect the protocol as&#xD;
      it was written initially. The citations section of this study registration also includes the&#xD;
      citation for the published protocol manuscript.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self Reported Binge Drinking Episodes</measure>
    <time_frame>12 months</time_frame>
    <description>Self reported number of binge drinking episodes over the previous 28 days assessed using the 28 day timeline follow back at 12 months.&#xD;
This outcome was corrected 3/2020 to accurately reflect the time frame from the original protocol.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Number of Weekly Drinks</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>Self reported mean number of weekly drinks as measured by a 28 day timeline follow back.&#xD;
This outcome was corrected 3/2020 to accurately reflect the time frame from the original protocol. It was also moved to the secondary outcome measure section as was the original intent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol-Related Negative Health Behaviors and Consequences: episodes of impaired drivin</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol-Related Negative Health Behaviors and Consequences: episodes riding with an impaired driver</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol-Related Negative Health Behaviors and Consequences: number of injuries</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol-Related Negative Health Behaviors and Consequences: number of arrests</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol-Related Negative Health Behaviors and Consequences: episodes of tardiness from work/school</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol-Related Negative Health Behaviors and Consequences: days absent from work/school</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>30 Day Treatment Engagement</measure>
    <time_frame>30 days post enrollment</time_frame>
    <description>Engagement in alcohol treatment program based on Treatment Services Review at 30 day phone follow up</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">840</enrollment>
  <condition>Alcohol Dependence</condition>
  <arm_group>
    <arm_group_label>AB-CASI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Automated Bilingual Computerized Alcohol Screening and Brief Negotiated Interview(BNI) Intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard Care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Computerized Alcohol Screening</intervention_name>
    <description>iPad based automated alcohol screening</description>
    <arm_group_label>AB-CASI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief Negotiated Interview</intervention_name>
    <description>iPad based automated brief negotiated interview (BNI)</description>
    <arm_group_label>AB-CASI</arm_group_label>
    <other_name>BNI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English and Spanish speaking adult&#xD;
&#xD;
          -  ≥ 18 y/o&#xD;
&#xD;
          -  Latino patients who present to the Bridgeport Hospital's ED&#xD;
&#xD;
          -  Drink over the NIAAA low-risk limits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary language other than English or Spanish&#xD;
&#xD;
          -  Current enrollment in an alcohol or substance abuse treatment program&#xD;
&#xD;
          -  Current ED visit for acute psychosis&#xD;
&#xD;
          -  Condition that precludes interview or AB-CASI use i.e., life threatening&#xD;
             injury/illness&#xD;
&#xD;
          -  In police custody&#xD;
&#xD;
          -  Inability to provide two contact numbers for follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Federico Vaca, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bridgeport Hospital</name>
      <address>
        <city>Bridgeport</city>
        <state>Connecticut</state>
        <zip>06610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Vaca FE, Dziura J, Abujarad F, Pantalon MV, Hsiao A, Field CA, D'Onofrio G. Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients. Contemp Clin Trials. 2020 Sep;96:106104. doi: 10.1016/j.cct.2020.106104. Epub 2020 Aug 7.</citation>
    <PMID>32777381</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alcohol Dependence</keyword>
  <keyword>Alcoholism</keyword>
  <keyword>AB-CASI</keyword>
  <keyword>Emergency Department</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02247388
org study id: 1211011052
secondary id: R01AA022083-01A1
nct id: NCT02247388
lead sponsor: 
collaborator: 
has dmc: Yes
To study the efficacy of AB-CASI against standard of care in a randomized controlled trial in
      the Emergency Department.
The research team will rigorously test the efficacy of AB-CASI, against a standard condition
      (SC) in a first-of-a-kind ED randomized controlled trial. Studying an urban adult (≥ 18 y/o)
      Latino ED population, the objectives are to demonstrate the superiority of AB-CASI compared
      to SC in: 1) reduction of alcohol consumption (Aims 1), 2) reduction of negative health
      behaviors and consequences (Aim 2), and 3) increasing 30-day treatment engagement (Aim 3).
      The investigators will also explore variation of the AB-CASI intervention on alcohol
      consumption, alcohol-related negative health behaviors and consequences, and 30-day treatment
      engagement by Latino subpopulations (Puerto-Rican, Mexican-American, Cuban-American,
      South/Central American) as well as other potential modifiers (age, birthplace, gender,
      preferred language, reason for ED visit, and smoking status). English and Spanish speaking
      Latino adults presenting to the Bridgeport Hospital ED will be screened using the study
      inclusion and exclusion criteria.

      In March 2020, the primary and secondary outcomes were corrected to reflect the protocol as
      it was written initially. The citations section of this study registration also includes the
      citation for the published protocol manuscript.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Self Reported Binge Drinking Episodes
time frame: 12 months
description: Self reported number of binge drinking episodes over the previous 28 days assessed using the 28 day timeline follow back at 12 months.
This outcome was corrected 3/2020 to accurately reflect the time frame from the original protocol.
measure: Mean Number of Weekly Drinks
time frame: 12 months post enrollment
description: Self reported mean number of weekly drinks as measured by a 28 day timeline follow back.
This outcome was corrected 3/2020 to accurately reflect the time frame from the original protocol. It was also moved to the secondary outcome measure section as was the original intent.
measure: Alcohol-Related Negative Health Behaviors and Consequences: episodes of impaired drivin
time frame: 12 months post enrollment
description: Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school)
measure: Alcohol-Related Negative Health Behaviors and Consequences: episodes riding with an impaired driver
time frame: 12 months post enrollment
description: Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school)
measure: Alcohol-Related Negative Health Behaviors and Consequences: number of injuries
time frame: 12 months post enrollment
description: Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school)
measure: Alcohol-Related Negative Health Behaviors and Consequences: number of arrests
time frame: 12 months post enrollment
description: Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school)
measure: Alcohol-Related Negative Health Behaviors and Consequences: episodes of tardiness from work/school
time frame: 12 months post enrollment
description: Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school)
measure: Alcohol-Related Negative Health Behaviors and Consequences: days absent from work/school
time frame: 12 months post enrollment
description: Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school)
measure: 30 Day Treatment Engagement
time frame: 30 days post enrollment
description: Engagement in alcohol treatment program based on Treatment Services Review at 30 day phone follow up
arm group label: AB-CASI
arm group type: Experimental
description: Automated Bilingual Computerized Alcohol Screening and Brief Negotiated Interview(BNI) Intervention
arm group label: Standard Care
arm group type: No Intervention
description: Standard Care
intervention type: Behavioral
intervention name: Computerized Alcohol Screening
description: iPad based automated alcohol screening
arm group label: AB-CASI
intervention type: Behavioral
intervention name: Brief Negotiated Interview
description: iPad based automated brief negotiated interview (BNI)
arm group label: AB-CASI
other name: BNI
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Federico Vaca, MD, MPH
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
citation: Vaca FE, Dziura J, Abujarad F, Pantalon MV, Hsiao A, Field CA, D'Onofrio G. Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients. Contemp Clin Trials. 2020 Sep;96:106104. doi: 10.1016/j.cct.2020.106104. Epub 2020 Aug 7.
PMID: 32777381
responsible party type: Sponsor
mesh term: Alcoholism