<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/NCT03041558</url>
  </required_header>
  <id_info>
    <org_study_id>20140475</org_study_id>
    <nct_id>NCT03041558</nct_id>
  </id_info>
  <brief_title>Evaluating Trauma-Informed, Evidence-Informed Interventions for Latino Families Experiencing Domestic Violence</brief_title>
  <official_title>SafeCare+: Implementing &amp; Evaluating Trauma-Informed, Evidence-Informed Interventions for Latino Families Experiencing Domestic Violence &amp; Child Maltreatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>South Bay Community Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>San Diego County Child Welfare Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Bureau - Administration for Children and Families</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project will evaluate the implementation and efficacy of a domestic violence&#xD;
      intervention module for parents receiving child welfare home visitation services.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ultimate goal of this proposed project is the provision of culturally-relevant,&#xD;
      trauma-informed services leading to a reduction of family violence, and a resultant increase&#xD;
      in family stability, improved communication, and a healthy home environment for children in&#xD;
      Latino families with co-occurring domestic violence (DV) and child abuse/neglect (CAN). The&#xD;
      Administration for Children, Youth and Families (ACYF) funded project and evaluation will be&#xD;
      layered onto the existing UC San Diego's NIH-funded R01 research (NIH R01 MH092950) on&#xD;
      scale-up of SafeCare (SC) across the entire San Diego Child Welfare System. In the first&#xD;
      phase of this project, the community and academic partners will collaborate to develop a&#xD;
      detailed evaluation plan by collecting formative qualitative data via focus groups with&#xD;
      active CW clients with domestic violence (DV) histories and community child welfare and DV&#xD;
      service providers. The second phase of this project will begin with the implementation of&#xD;
      SafeCare+ (SC+), an evidence-based training curriculum for parents referred for child&#xD;
      maltreatment, coupled with the Healthy Relationships (HR) module for Latino families with&#xD;
      co-occurring child maltreatment and domestic violence experiences. SafeCare® (SC) has been&#xD;
      shown to be widely accepted among the Latino community and the HR module has been&#xD;
      specifically adapted for and successfully utilized with Latino populations. As part of the&#xD;
      expansion of the original research study, 80 clients who will be recruited into the existing&#xD;
      study will also be randomly assigned to receive the additional HR module.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2013</start_date>
  <completion_date type="Actual">June 2020</completion_date>
  <primary_completion_date type="Actual">January 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>Factorial Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fidelity</measure>
    <time_frame>4 years</time_frame>
    <description>Fidelity monitoring will begin simultaneously with the implementation of SafeCare (SC®). Fidelity is assessed largely via client report, with clients completing a fidelity questionnaire at the end of every SC or SC+ session. A secondary fidelity component utilizes information gained from the natural implementation of SC®. SC+ includes ongoing consultation in the form of expert SC® clinicians who accompany home visitors, observe their interactions with families, and coach them on improving performance and services.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in level of domestic violence</measure>
    <time_frame>4 years</time_frame>
    <description>The Conflict Tactic Scale (CTS2): measures both the extent to which partners in a dating, cohabiting, or marital relationship engage in psychological and physical attacks on each other and also their use of reasoning or negotiation to deal with conflicts.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Client depression</measure>
    <time_frame>4 years</time_frame>
    <description>The Center for Epidemiologic Studies Depression Scale (CES-D) (Radloff, 1977) is a 20-item questionnaire which assesses depressive symptomology.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Interpersonal Relations</condition>
  <arm_group>
    <arm_group_label>SafeCare+ (SC+)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SafeCare intervention with the additional Healthy Relationships (HR) module</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SafeCare (SC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SafeCare intervention as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SafeCare+ (SC+)</intervention_name>
    <description>SafeCare intervention with the additional Healthy Relationships (HR) module</description>
    <arm_group_label>SafeCare+ (SC+)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SafeCare (SC)</intervention_name>
    <description>SafeCare intervention as usual</description>
    <arm_group_label>SafeCare (SC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Service providers (CWS and DV) and active CW clients with DV histories will be&#xD;
             recruited via random selection to participate in focus groups during the planning year&#xD;
             of the project.&#xD;
&#xD;
          -  Latino families are eligible for the RCT based on the following criteria: (a) being&#xD;
             identified as an appropriate family for SafeCare; and (b) by having at least one,&#xD;
             qualifying DV experience, which will be determined during the baseline needs&#xD;
             assessment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A client will be excluded if he/she indicates to the service provider that they are&#xD;
             unable to comprehend the written questionnaire and cannot obtain outside assistance in&#xD;
             understanding and completing the questionnaire.&#xD;
&#xD;
          -  Clients under the age of 18 will able be excluded because they cannot provide informed&#xD;
             consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UC San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>May 21, 2021</last_update_submitted>
  <last_update_submitted_qc>May 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Gregory Aarons</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>healthy relationships</keyword>
  <keyword>interpersonal relations</keyword>
  <keyword>domestic violence</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03041558
org study id: 20140475
nct id: NCT03041558
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This project will evaluate the implementation and efficacy of a domestic violence
      intervention module for parents receiving child welfare home visitation services.
The ultimate goal of this proposed project is the provision of culturally-relevant,
      trauma-informed services leading to a reduction of family violence, and a resultant increase
      in family stability, improved communication, and a healthy home environment for children in
      Latino families with co-occurring domestic violence (DV) and child abuse/neglect (CAN). The
      Administration for Children, Youth and Families (ACYF) funded project and evaluation will be
      layered onto the existing UC San Diego's NIH-funded R01 research (NIH R01 MH092950) on
      scale-up of SafeCare (SC) across the entire San Diego Child Welfare System. In the first
      phase of this project, the community and academic partners will collaborate to develop a
      detailed evaluation plan by collecting formative qualitative data via focus groups with
      active CW clients with domestic violence (DV) histories and community child welfare and DV
      service providers. The second phase of this project will begin with the implementation of
      SafeCare+ (SC+), an evidence-based training curriculum for parents referred for child
      maltreatment, coupled with the Healthy Relationships (HR) module for Latino families with
      co-occurring child maltreatment and domestic violence experiences. SafeCare® (SC) has been
      shown to be widely accepted among the Latino community and the HR module has been
      specifically adapted for and successfully utilized with Latino populations. As part of the
      expansion of the original research study, 80 clients who will be recruited into the existing
      study will also be randomly assigned to receive the additional HR module.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Fidelity
time frame: 4 years
description: Fidelity monitoring will begin simultaneously with the implementation of SafeCare (SC®). Fidelity is assessed largely via client report, with clients completing a fidelity questionnaire at the end of every SC or SC+ session. A secondary fidelity component utilizes information gained from the natural implementation of SC®. SC+ includes ongoing consultation in the form of expert SC® clinicians who accompany home visitors, observe their interactions with families, and coach them on improving performance and services.
measure: Change in level of domestic violence
time frame: 4 years
description: The Conflict Tactic Scale (CTS2): measures both the extent to which partners in a dating, cohabiting, or marital relationship engage in psychological and physical attacks on each other and also their use of reasoning or negotiation to deal with conflicts.
measure: Client depression
time frame: 4 years
description: The Center for Epidemiologic Studies Depression Scale (CES-D) (Radloff, 1977) is a 20-item questionnaire which assesses depressive symptomology.
arm group label: SafeCare+ (SC+)
arm group type: Experimental
description: SafeCare intervention with the additional Healthy Relationships (HR) module
arm group label: SafeCare (SC)
arm group type: Active Comparator
description: SafeCare intervention as usual
intervention type: Behavioral
intervention name: SafeCare+ (SC+)
description: SafeCare intervention with the additional Healthy Relationships (HR) module
arm group label: SafeCare+ (SC+)
intervention type: Behavioral
intervention name: SafeCare (SC)
description: SafeCare intervention as usual
arm group label: SafeCare (SC)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Gregory Aarons
investigator title: Professor
sharing ipd: No