<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/NCT01709552</url>
  </required_header>
  <id_info>
    <org_study_id>5K23DA031881-02</org_study_id>
    <nct_id>NCT01709552</nct_id>
  </id_info>
  <brief_title>Brief Intervention for Substance Use and Partner Abuse Among Females in the ER</brief_title>
  <acronym>B-SAFER</acronym>
  <official_title>A Computer-based Intervention for Women With Substance Use and Intimate Partner Violence in the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rhode Island Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rhode Island Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to target co-occurring problems of substance use and intimate&#xD;
      partner violence (IPV) using a computer-based intervention, B-SAFER (Brief intervention for&#xD;
      Substance use and partner Abuse for Females in the Emergency Room). This project will develop&#xD;
      and test the computer-based intervention, examining primary outcomes of substance use and&#xD;
      utilization of relationship safety resources.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in past-month drug use days</measure>
    <time_frame>1 month, 3 month</time_frame>
    <description>Drug use based on Timeline Followback.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in use of relationship safety behaviors and referral resources for IPV.</measure>
    <time_frame>2 weeks, 1 month, 3 months</time_frame>
    <description>Based on Safety Behavior Checklist and Effectiveness in Obtaining Resources scales.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in readiness to change drug use.</measure>
    <time_frame>2 week, 1 month, 3 months</time_frame>
    <description>Based on readiness to change rulers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in readiness to change scale for relationship safety behaviors.</measure>
    <time_frame>2 weeks, 1 month, 3 months</time_frame>
    <description>Based on readiness to change rulers.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Substance Related Disorders</condition>
  <condition>Domestic Violence</condition>
  <arm_group>
    <arm_group_label>Computer Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to the computer intervention will complete the B-SAFER computer program during their emergency department visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients randomized to the control arm will receive a time-equivalent computer-based program unrelated to substance use or partner violence.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Computer Intervention</intervention_name>
    <description>Patients randomized to the computer intervention will complete the B-SAFER computer program during their emergency department visit.</description>
    <arm_group_label>Computer Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Patients randomized to the control arm will receive a time-equivalent computer-based program unrelated to substance use or partner violence.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age&#xD;
&#xD;
          -  English or Spanish language proficiency sufficient to understand and complete study&#xD;
             procedures&#xD;
&#xD;
          -  moderate drug use in the prior 3 months (by NM-ASSIST)&#xD;
&#xD;
          -  IPV victimization in the prior 6 months (by WAST)&#xD;
&#xD;
          -  access to a phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who are:&#xD;
&#xD;
          -  intoxicated&#xD;
&#xD;
          -  medically unstable as determined by ED staff&#xD;
&#xD;
          -  suicidal ideation&#xD;
&#xD;
          -  psychosis&#xD;
&#xD;
          -  combative&#xD;
&#xD;
          -  in police custody&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Esther K Choo, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rhode Island Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rhode Island Hospital Department of Emergency Medicine</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>May 21, 2015</last_update_submitted>
  <last_update_submitted_qc>May 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rhode Island Hospital</investigator_affiliation>
    <investigator_full_name>Esther Choo</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</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/NCT01709552
org study id: 5K23DA031881-02
nct id: NCT01709552
lead sponsor: 
has dmc: Yes
The purpose of this study is to target co-occurring problems of substance use and intimate
      partner violence (IPV) using a computer-based intervention, B-SAFER (Brief intervention for
      Substance use and partner Abuse for Females in the Emergency Room). This project will develop
      and test the computer-based intervention, examining primary outcomes of substance use and
      utilization of relationship safety resources.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in past-month drug use days
time frame: 1 month, 3 month
description: Drug use based on Timeline Followback.
measure: Change in use of relationship safety behaviors and referral resources for IPV.
time frame: 2 weeks, 1 month, 3 months
description: Based on Safety Behavior Checklist and Effectiveness in Obtaining Resources scales.
measure: Change in readiness to change drug use.
time frame: 2 week, 1 month, 3 months
description: Based on readiness to change rulers.
measure: Change in readiness to change scale for relationship safety behaviors.
time frame: 2 weeks, 1 month, 3 months
description: Based on readiness to change rulers.
arm group label: Computer Intervention
arm group type: Experimental
description: Patients randomized to the computer intervention will complete the B-SAFER computer program during their emergency department visit.
arm group label: Control
arm group type: Sham Comparator
description: Patients randomized to the control arm will receive a time-equivalent computer-based program unrelated to substance use or partner violence.
intervention type: Behavioral
intervention name: Computer Intervention
description: Patients randomized to the computer intervention will complete the B-SAFER computer program during their emergency department visit.
arm group label: Computer Intervention
intervention type: Behavioral
intervention name: Control
description: Patients randomized to the control arm will receive a time-equivalent computer-based program unrelated to substance use or partner violence.
arm group label: Control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Esther K Choo, MD MPH
role: Principal Investigator
affiliation: Rhode Island Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rhode Island Hospital
investigator full name: Esther Choo
investigator title: Assistant Professor
mesh term: Substance-Related Disorders