<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/NCT03828370</url>
  </required_header>
  <id_info>
    <org_study_id>0320</org_study_id>
    <secondary_id>2R44AA022850-02</secondary_id>
    <nct_id>NCT03828370</nct_id>
  </id_info>
  <brief_title>DWI Offenders and Their Families App for Smartphones</brief_title>
  <acronym>B-SMART</acronym>
  <official_title>Smartphone Help for DWI Offenders and Their Families: A B-SMART App</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Klein Buendel, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Klein Buendel, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The smart phone application (B-SMART) to be developed in this research project for family&#xD;
      members of DWI (Driving While Intoxicated) offenders and offenders themselves will extend the&#xD;
      impact of the Ignition Interlock Device (IID) and help DWI offenders and their families avoid&#xD;
      drunk driving once the IID is removed from their automobiles. As such, the public health&#xD;
      consequences of DWI, in terms of health, morbidity and mortality, and its economic and&#xD;
      societal consequences, will be positively influenced by a highly accessible and diffusible&#xD;
      intervention. The proposed Phase II project will complete the development and programming of&#xD;
      the B-SMART smartphone web app and test its impact in a randomized efficacy trial with&#xD;
      first-time DWI offenders and their concerned family members.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Driving while intoxicated (DWI) remains a substantial and preventable source of morbidity and&#xD;
      mortality in the United States. A variety of sanctions and interventions have been attempted&#xD;
      to reduce DWI in the U.S., including enhanced DWI enforcement efforts, stricter drunk driving&#xD;
      laws, responsible alcohol beverage service training, and alcohol treatment. The Ignition&#xD;
      Interlock Device (IID), which requires a driver to blow into a breathalyzer unit installed in&#xD;
      an automobile to establish sobriety, reduces drunk driving while installed. The use of IIDs&#xD;
      has become widespread: most states in the U.S. now require convicted drunk drivers to install&#xD;
      an IID in their cars upon some form of conviction. However, research has conclusively shown&#xD;
      that once the IIDs are removed from DWI offenders' cars, DWI recidivism levels return to&#xD;
      those comparable to offenders who did not have an IID. Interventions are needed to increase&#xD;
      the likelihood that the effectiveness of IIDs persists beyond the installation period. The&#xD;
      Brief Family-Involved Treatment (B-FIT) is a promising intervention to improve DWI recidivism&#xD;
      by affecting the social environment of DWI offenders. Proposed here is Phase II research, a&#xD;
      continuation of the original Phase I project, that will complete the translation of B-FIT&#xD;
      into the B-SMART mobile web app for smartphones. The content of the intervention will be&#xD;
      based on empirically-validated couples therapy for those with alcohol use disorders developed&#xD;
      by Co-Investigator McCrady, translated to a smartphone platform. Phase II of this project&#xD;
      will involve the systematic completion of B-SMART, employing: 1) an Expert Advisory Board,&#xD;
      and 2) iterative development, multimedia and usability focus groups, and interviews comprised&#xD;
      of CFM and DWI offenders. B-SMART will be fully produced for DWI offenders and their&#xD;
      concerned family members (CFM) and then tested in a randomized controlled efficacy trial with&#xD;
      first-time DWI offenders (n=150) and their CFMs (n=150) recruited from the Santa Fe County&#xD;
      DWI Program. Unique to this intervention are the involvement of family members in supporting&#xD;
      the DWI offender to not drink and drive and the use of smartphone technology to make that&#xD;
      support immediate, accessible, and diffusible. B-SMART will involve the CFMs by providing&#xD;
      coping skills, communication skills, and strategies to help avoid DWI. The randomized&#xD;
      efficacy trial of B-SMART will examine B-SMART's impact on a variety of alcohol-related&#xD;
      dependent variables, including IID lockout events, alcohol use, and family functioning.&#xD;
      Should B-SMART be demonstrated to impact DWI offenders and their family members by reducing&#xD;
      IID Lockout Events (which predict future DWI recidivism) and alcohol use, and improving&#xD;
      family functioning, DWI offenders, their families, and their communities will have an&#xD;
      important, effective, accessible tool to further reduce the social, health and economic&#xD;
      consequences of DWI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 30, 2019</start_date>
  <completion_date type="Actual">March 31, 2023</completion_date>
  <primary_completion_date type="Actual">March 31, 2023</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>
    <intervention_model_description>The B-SMART mobile web app will be evaluated in a randomized pretest-posttest controlled design. First-time DWI offenders and their CFMs will be randomized together to the intervention (B-SMART) or a usual and customary (UC) IID information condition comparison group (n=150) following baseline assessment.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of Primary Outcome Variable: IID Lockout Events.</measure>
    <time_frame>9 months</time_frame>
    <description>The primary outcome measure will be frequency of IID lockout events from baseline to 9-month follow-up post-randomization, collected from the Santa Fe DWI program database for each first-time DWI offender participant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measures of Secondary Outcome Variables and Mediators.</measure>
    <time_frame>9 months</time_frame>
    <description>Alcohol use by the DWI offender, a secondary outcome, will be assessed at baseline, 3-month follow-up, and 9-month follow-up with versions of the Form 9090,91 adapted for online assessment for the CFMs (Form 90-ACS) and first-time DWI offenders (Form 90-AF).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Coping Skills</condition>
  <condition>Family Relations</condition>
  <arm_group>
    <arm_group_label>Usual &amp; Customary Information Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study Cohort Assessment:&#xD;
Baseline 3 month follow-up/ post-test 9 month follow-up/post test &amp; Interlock Ignition Device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B-SMART Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study Cohort Assessment:&#xD;
Baseline Web App Intervention 3 month follow-up/ post-test 9 month follow-up/post test &amp; Interlock Ignition Device</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>B-SMART Intervention Group</intervention_name>
    <description>The B-SMART mobile web app will contain four modules: 1) Supporting Abstinence, 2) Shared Positive Activities, 3) Common Challenges for Family Members with IID, and 4) Effective Communication. Within each module there will be a series of learning activities, including presentation text, interactive engagement, and videos. All app content will be available in both English and Spanish, based on user language preference.</description>
    <arm_group_label>B-SMART Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual and Customary Information Group</intervention_name>
    <description>Participants randomized to the usual and customary care (UC) group will receive a website with a pamphlet on the IID installed in their vehicle and the manufacturer information provided about the IID in PDF format, in both English and Spanish. This constitutes a UC group, as such pamphlets are widely available to DWI offenders who have IIDs installed in their vehicles. Thus, providing this pamphlet represents a standard information provision for first-time DWI offenders and their CFMs.</description>
    <arm_group_label>Usual &amp; Customary Information Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        DWI Offender&#xD;
&#xD;
          -  male or female&#xD;
&#xD;
          -  21 years or older&#xD;
&#xD;
          -  first-time DWI offender with IID installed in vehicle&#xD;
&#xD;
          -  enrolled in Santa Fe County DWI Program&#xD;
&#xD;
          -  have a smartphone, tablet computer, or personal computer with Internet access&#xD;
&#xD;
          -  consent to participate&#xD;
&#xD;
          -  able to read and speak English or Spanish&#xD;
&#xD;
        Concerned Family Member (CFM):&#xD;
&#xD;
          -  male or female&#xD;
&#xD;
          -  21 years or older&#xD;
&#xD;
          -  spouse, parent, or immediate family member of first-time DWI offender with IID&#xD;
             installed in vehicle and enrolled in Santa Fe County DWI Program&#xD;
&#xD;
          -  have a smartphone, tablet computer, or personal computer with Internet access&#xD;
&#xD;
          -  consent to participate&#xD;
&#xD;
          -  able to read and speak English or Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other family members already enrolled in the project&#xD;
&#xD;
          -  second or above DWI conviction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gill Woodall, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klein Buendel, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klein Buendel, Inc</name>
      <address>
        <city>Golden</city>
        <state>Colorado</state>
        <zip>80401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of New Mexico</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03828370
org study id: 0320
secondary id: 2R44AA022850-02
nct id: NCT03828370
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The smart phone application (B-SMART) to be developed in this research project for family
      members of DWI (Driving While Intoxicated) offenders and offenders themselves will extend the
      impact of the Ignition Interlock Device (IID) and help DWI offenders and their families avoid
      drunk driving once the IID is removed from their automobiles. As such, the public health
      consequences of DWI, in terms of health, morbidity and mortality, and its economic and
      societal consequences, will be positively influenced by a highly accessible and diffusible
      intervention. The proposed Phase II project will complete the development and programming of
      the B-SMART smartphone web app and test its impact in a randomized efficacy trial with
      first-time DWI offenders and their concerned family members.
Driving while intoxicated (DWI) remains a substantial and preventable source of morbidity and
      mortality in the United States. A variety of sanctions and interventions have been attempted
      to reduce DWI in the U.S., including enhanced DWI enforcement efforts, stricter drunk driving
      laws, responsible alcohol beverage service training, and alcohol treatment. The Ignition
      Interlock Device (IID), which requires a driver to blow into a breathalyzer unit installed in
      an automobile to establish sobriety, reduces drunk driving while installed. The use of IIDs
      has become widespread: most states in the U.S. now require convicted drunk drivers to install
      an IID in their cars upon some form of conviction. However, research has conclusively shown
      that once the IIDs are removed from DWI offenders' cars, DWI recidivism levels return to
      those comparable to offenders who did not have an IID. Interventions are needed to increase
      the likelihood that the effectiveness of IIDs persists beyond the installation period. The
      Brief Family-Involved Treatment (B-FIT) is a promising intervention to improve DWI recidivism
      by affecting the social environment of DWI offenders. Proposed here is Phase II research, a
      continuation of the original Phase I project, that will complete the translation of B-FIT
      into the B-SMART mobile web app for smartphones. The content of the intervention will be
      based on empirically-validated couples therapy for those with alcohol use disorders developed
      by Co-Investigator McCrady, translated to a smartphone platform. Phase II of this project
      will involve the systematic completion of B-SMART, employing: 1) an Expert Advisory Board,
      and 2) iterative development, multimedia and usability focus groups, and interviews comprised
      of CFM and DWI offenders. B-SMART will be fully produced for DWI offenders and their
      concerned family members (CFM) and then tested in a randomized controlled efficacy trial with
      first-time DWI offenders (n=150) and their CFMs (n=150) recruited from the Santa Fe County
      DWI Program. Unique to this intervention are the involvement of family members in supporting
      the DWI offender to not drink and drive and the use of smartphone technology to make that
      support immediate, accessible, and diffusible. B-SMART will involve the CFMs by providing
      coping skills, communication skills, and strategies to help avoid DWI. The randomized
      efficacy trial of B-SMART will examine B-SMART's impact on a variety of alcohol-related
      dependent variables, including IID lockout events, alcohol use, and family functioning.
      Should B-SMART be demonstrated to impact DWI offenders and their family members by reducing
      IID Lockout Events (which predict future DWI recidivism) and alcohol use, and improving
      family functioning, DWI offenders, their families, and their communities will have an
      important, effective, accessible tool to further reduce the social, health and economic
      consequences of DWI.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The B-SMART mobile web app will be evaluated in a randomized pretest-posttest controlled design. First-time DWI offenders and their CFMs will be randomized together to the intervention (B-SMART) or a usual and customary (UC) IID information condition comparison group (n=150) following baseline assessment.
primary purpose: Supportive Care
masking: Double (Participant, Care Provider)
measure: Measure of Primary Outcome Variable: IID Lockout Events.
time frame: 9 months
description: The primary outcome measure will be frequency of IID lockout events from baseline to 9-month follow-up post-randomization, collected from the Santa Fe DWI program database for each first-time DWI offender participant.
measure: Measures of Secondary Outcome Variables and Mediators.
time frame: 9 months
description: Alcohol use by the DWI offender, a secondary outcome, will be assessed at baseline, 3-month follow-up, and 9-month follow-up with versions of the Form 9090,91 adapted for online assessment for the CFMs (Form 90-ACS) and first-time DWI offenders (Form 90-AF).
arm group label: Usual & Customary Information Group
arm group type: Active Comparator
description: Study Cohort Assessment:
Baseline 3 month follow-up/ post-test 9 month follow-up/post test & Interlock Ignition Device
arm group label: B-SMART Intervention Group
arm group type: Experimental
description: Study Cohort Assessment:
Baseline Web App Intervention 3 month follow-up/ post-test 9 month follow-up/post test & Interlock Ignition Device
intervention type: Behavioral
intervention name: B-SMART Intervention Group
description: The B-SMART mobile web app will contain four modules: 1) Supporting Abstinence, 2) Shared Positive Activities, 3) Common Challenges for Family Members with IID, and 4) Effective Communication. Within each module there will be a series of learning activities, including presentation text, interactive engagement, and videos. All app content will be available in both English and Spanish, based on user language preference.
arm group label: B-SMART Intervention Group
intervention type: Behavioral
intervention name: Usual and Customary Information Group
description: Participants randomized to the usual and customary care (UC) group will receive a website with a pamphlet on the IID installed in their vehicle and the manufacturer information provided about the IID in PDF format, in both English and Spanish. This constitutes a UC group, as such pamphlets are widely available to DWI offenders who have IIDs installed in their vehicles. Thus, providing this pamphlet represents a standard information provision for first-time DWI offenders and their CFMs.
arm group label: Usual & Customary Information Group
criteria: 
gender: All
minimum age: 21 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gill Woodall, PhD
role: Principal Investigator
affiliation: Klein Buendel, Inc.
facility: 
facility: 
country: United States
responsible party type: Sponsor