<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/NCT03288935</url>
  </required_header>
  <id_info>
    <org_study_id>HM20011389</org_study_id>
    <nct_id>NCT03288935</nct_id>
  </id_info>
  <brief_title>Trauma Informed Care for Newly Resettled Refugees</brief_title>
  <official_title>Trauma Informed Care for Refugee Newcomers in Virginia: A Factorial Design of Effectiveness-Implementation Hybrid Research</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Virginia Commonwealth University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to evaluate early-phase interventions for refugee wellness&#xD;
      promotion and build evidence for dissemination of the intervention model and curricula&#xD;
      through refugee resettlement programs, local and national.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will examine the main effects of trauma-informed case management (TICM) and&#xD;
      trauma-informed cultural orientation (TICO) interventions, respectively, in reducing&#xD;
      resettlement distress and increasing coping capacity, which will improve emotional wellness&#xD;
      and social adaptation and thus resettlement outcomes. This project will also test the&#xD;
      interaction effects of two-tiered intervention model, discerning effective and ineffective&#xD;
      components of the intervention model. Differences in effects across intervention conditions&#xD;
      may inform how improvement in what outcomes or which phase can affect refugees' wellness and&#xD;
      adjustment over time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    A substantial decrease in refugee arrivals in Virginia didn't allow the investigator to&#xD;
    continue the study as planned.&#xD;
  </why_stopped>
  <start_date type="Anticipated">August 28, 2018</start_date>
  <completion_date type="Anticipated">May 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 20, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in resettlement distress</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>Penn State Worry Questionnaire, which captures pervasiveness, excessiveness, and uncontrollability of worry. Scores range from 16 to 80 with higher values indicating more worry.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in emotional well-being</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>Refugee Health Screener-15, a 75 item screening tool with lower scores indicating better well-being</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resettlement Outcomes</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>Post-Migration Living Difficulties, a self-assessment tool which measures adverse post -migration experiences in five different domains, included two related asylum-seeking factors. Scores range from 23 to 115 with higher values indicating more serious problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Social Adaptation</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>Social Adaptation Self-evaluation Scale. Scores range from 0 to 63 with higher values indicating better social adjustment.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Mental Stress</condition>
  <condition>Emotional Stress</condition>
  <arm_group>
    <arm_group_label>Group 1 (TICM only)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Assigned to TICM group after reception &amp; placement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 (TICO only)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Assigned to TICO group after reception &amp; placement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3 (TICM &amp; TICO)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Assigned to both TICM and TICO group after reception &amp; placement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4 (None)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No additional intervention after reception &amp; placement</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TICM</intervention_name>
    <description>The TICM will be designed to include the seven domains of trauma-informed care articulated by SAMHSA (2014): 1) early screening and comprehensive assessment; 2) consumer driven care and services; 3) trauma-informed, responsive and educated workforce; 4) emerging and evidence-informed best practices; 5) safe and secure environments; 6) trauma-informed community partnerships; and 7) a performance monitoring system. The trained agency case managers and staff will provide the TICM to 50 newly resettled refugees during their regular R&amp;P service period (i.e., 60 days).</description>
    <arm_group_label>Group 1 (TICM only)</arm_group_label>
    <arm_group_label>Group 3 (TICM &amp; TICO)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TICO</intervention_name>
    <description>The community-based TICO will be based on the Im's CHW that comprises 8 sessions (2 hour per session), co-facilitated by trained refugee peer mentors and community service providers. The TICO sessions will include interactive sessions on healthy eating, healthy body and healthy mind, acculturation &amp; resettlement stress, understanding trauma and stress, healthy coping, helping others, and community building.</description>
    <arm_group_label>Group 2 (TICO only)</arm_group_label>
    <arm_group_label>Group 3 (TICM &amp; TICO)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Refugee adults who arrive in Richmond or Charlottesville between January and February&#xD;
             2018&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>Hyojin Im, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth Univeristy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>refugee</keyword>
  <keyword>trauma-informed case management (TICM)</keyword>
  <keyword>trauma-informed cultural orientation (TICO)</keyword>
  <keyword>PTSD</keyword>
  <keyword>depression</keyword>
  <keyword>refugee resettlement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</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/NCT03288935
org study id: HM20011389
nct id: NCT03288935
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to evaluate early-phase interventions for refugee wellness
      promotion and build evidence for dissemination of the intervention model and curricula
      through refugee resettlement programs, local and national.
This study will examine the main effects of trauma-informed case management (TICM) and
      trauma-informed cultural orientation (TICO) interventions, respectively, in reducing
      resettlement distress and increasing coping capacity, which will improve emotional wellness
      and social adaptation and thus resettlement outcomes. This project will also test the
      interaction effects of two-tiered intervention model, discerning effective and ineffective
      components of the intervention model. Differences in effects across intervention conditions
      may inform how improvement in what outcomes or which phase can affect refugees' wellness and
      adjustment over time.
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in resettlement distress
time frame: Baseline to 6 months
description: Penn State Worry Questionnaire, which captures pervasiveness, excessiveness, and uncontrollability of worry. Scores range from 16 to 80 with higher values indicating more worry.
measure: Change in emotional well-being
time frame: Baseline to 6 months
description: Refugee Health Screener-15, a 75 item screening tool with lower scores indicating better well-being
measure: Resettlement Outcomes
time frame: Baseline to 6 months
description: Post-Migration Living Difficulties, a self-assessment tool which measures adverse post -migration experiences in five different domains, included two related asylum-seeking factors. Scores range from 23 to 115 with higher values indicating more serious problems.
measure: Change in Social Adaptation
time frame: Baseline to 6 months
description: Social Adaptation Self-evaluation Scale. Scores range from 0 to 63 with higher values indicating better social adjustment.
arm group label: Group 1 (TICM only)
arm group type: Active Comparator
description: Assigned to TICM group after reception & placement.
arm group label: Group 2 (TICO only)
arm group type: Active Comparator
description: Assigned to TICO group after reception & placement.
arm group label: Group 3 (TICM & TICO)
arm group type: Active Comparator
description: Assigned to both TICM and TICO group after reception & placement.
arm group label: Group 4 (None)
arm group type: No Intervention
description: No additional intervention after reception & placement
intervention type: Behavioral
intervention name: TICM
description: The TICM will be designed to include the seven domains of trauma-informed care articulated by SAMHSA (2014): 1) early screening and comprehensive assessment; 2) consumer driven care and services; 3) trauma-informed, responsive and educated workforce; 4) emerging and evidence-informed best practices; 5) safe and secure environments; 6) trauma-informed community partnerships; and 7) a performance monitoring system. The trained agency case managers and staff will provide the TICM to 50 newly resettled refugees during their regular R&P service period (i.e., 60 days).
arm group label: Group 1 (TICM only)
arm group label: Group 3 (TICM & TICO)
intervention type: Behavioral
intervention name: TICO
description: The community-based TICO will be based on the Im's CHW that comprises 8 sessions (2 hour per session), co-facilitated by trained refugee peer mentors and community service providers. The TICO sessions will include interactive sessions on healthy eating, healthy body and healthy mind, acculturation & resettlement stress, understanding trauma and stress, healthy coping, helping others, and community building.
arm group label: Group 2 (TICO only)
arm group label: Group 3 (TICM & TICO)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hyojin Im, PhD
role: Principal Investigator
affiliation: Virginia Commonwealth Univeristy
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stress, Psychological