xml: <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/NCT05991739</url>
    </required_header>
    <id_info>
      <org_study_id>2022-0108</org_study_id>
      <secondary_id>CTSA UL1TR002003</secondary_id>
      <nct_id>NCT05991739</nct_id>
    </id_info>
    <brief_title>Pilot Testing of a Structural Racism Intervention for Immigrant Latinx Families</brief_title>
    <official_title>Pilot Testing of a Structural Racism Intervention for Immigrant Latinx Families: Blending of Implementation Science and Community-Engaged Research</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Illinois at Chicago</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Resurrection Project</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Illinois at Chicago</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 purpose of this study is to evaluate a new, community-based, group intervention called&#xD;
        FIESTA (Familias Inmigrantes Empoderándose contra eStrés Tomando Acción) to understand how&#xD;
        well it helps Latinx immigrant families deal with the impact of stress due to structural&#xD;
        racism. Structural racism is defined as the policies, practices, and norms that work together&#xD;
        to limit equal opportunities for minority communities. For Latinx immigrant families, this&#xD;
        can include fears of deportation, lack of bilingual providers, and discrimination. These&#xD;
        experiences of structural racism can turn into stress, which impacts well-being and mental&#xD;
        health.&#xD;
  &#xD;
        Researchers will investigate if: 1) FIESTA lowers stress and mental health symptoms&#xD;
        (anxiety/depression) and increases feelings of empowerment, improved knowledge of resources,&#xD;
        better parent-youth relationship quality, and higher use of healthy coping skills; and 2)&#xD;
        FIESTA is feasible (easy to carry out), acceptable (agreeable or satisfactory), and&#xD;
        appropriate (relevant to the needs of Latinx families).&#xD;
  &#xD;
        FIESTA is ten-sessions and will be led by two community health workers. Researchers will&#xD;
        enroll 35 parent-adolescent dyads (35 study-eligible parents and 35 study-eligible youth) in&#xD;
        the initial study. This study will randomize parent-youth dyads to the treatment arm or&#xD;
        waitlist-control arm using block randomization. In other words, participants will be randomly&#xD;
        assigned to one of two groups, the First Group, or the Second Group. The First Group will&#xD;
        begin immediately, and the Second Group will begin after three months. Data will be collected&#xD;
        at baseline and three- and six-month post-baseline.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of the study is to pilot test a new, evidence-informed group intervention (FIESTA)&#xD;
        among Latina immigrant mothers and youth (ages 14-17) and determine preliminary evidence as&#xD;
        well as acceptability, appropriateness, and feasibility. FIESTA was developed in&#xD;
        collaboration with a local community-based organization, the research team's established&#xD;
        community partner.&#xD;
  &#xD;
        Participants will be recruited through the research team's established community partnership.&#xD;
        To participate in FIESTA, both the caregiver and child are required to participate.&#xD;
        Researchers will enroll 35 parent-adolescent dyads (35 study-eligible parents and 35&#xD;
        study-eligible youth) in the initial pilot study. This study will randomize parent-youth&#xD;
        dyads to the treatment arm or waitlist-control arm using block randomization. Each group will&#xD;
        have 7-9 dyads, with two groups running simultaneously (treatment arm) and the remaining two&#xD;
        groups running in three months (waitlist-control arm). After all participants are enrolled,&#xD;
        families will be randomly selected to participate in either the treatment arm (immediate&#xD;
        start) or waitlist-control arm (delayed start after 3 months). Participants in the treatment&#xD;
        arm will begin the intervention immediately (Time 1) and the waitlist-control arm will wait&#xD;
        approximately three months for the intervention (Time 2). All participants will be reassessed&#xD;
        at Time 2 (after 3-months) and again at Time 3 (after 6-months), once the wait-control group&#xD;
        has completed the intervention. After the intervention (Time 2 for the treatment arm and Time&#xD;
        3 for the waitlist-control arm), participants will be asked a series of questions about the&#xD;
        FIESTA intervention to assess for appropriateness, acceptability, and feasibility. All data&#xD;
        collection will be completed by the research team.&#xD;
  &#xD;
        Each FIESTA group will be led by two community health workers who will not be involved in the&#xD;
        research and will not know who participates in the study. The community health workers will&#xD;
        meet the following criteria: 1) have participated in a leadership role at the community-based&#xD;
        organization or an affiliated organization for at least one year; 2) have experience&#xD;
        facilitating at least one workshop; and 3) attend and participate in a three-day training for&#xD;
        FIESTA led by the PI.&#xD;
  &#xD;
        Each FIESTA session is two hours and will occur over ten weeks. FIESTA covers strategies&#xD;
        related to individual stress management, family coping and communication, and community&#xD;
        navigation. Throughout the sessions, there is an emphasis on sharing community-based&#xD;
        resources if parents or youth are interested in obtaining future services. Each session will&#xD;
        run parent and youth groups simultaneously, with a parent-youth activity built into each&#xD;
        session. Parent and youth groups will be delivered separately to allow for a private space to&#xD;
        discuss sensitive topics and practice skills. Material delivered to youth has been&#xD;
        developmentally tailored. Session One provides participants with psychoeducation of stress,&#xD;
        including the behavioral, emotional, and cognitive signs of stress, and focuses on&#xD;
        recognizing stressors within Latinx communities. Session Two focuses on introducing the&#xD;
        cognitive triangle and encourages participants to identify how their feelings, thoughts, and&#xD;
        behaviors are connected. Participants will also learn evidence-based relaxation and&#xD;
        mindfulness techniques that they will practice throughout the remainder of the sessions.&#xD;
        Session Three teaches challenging negative thoughts and problem-solving techniques, using&#xD;
        vignettes geared towards Latinx families (e.g., navigating language constraints at work).&#xD;
        Session Four focuses on improving communication between parents and their children by&#xD;
        teaching &quot;I statements&quot; and active listening through a series of role plays. Session Five is&#xD;
        facilitated by an outside consultant recommended by the community partner and teaches about&#xD;
        empowerment, the relationship between empowerment and self-esteem, and recognition of&#xD;
        internal strengths and external support systems. Session Six focuses on principles developed&#xD;
        from Know Your Rights trainings, including understanding rights when interacting with ICE and&#xD;
        police and how to create a family emergency plan. Session Seven encourages participants to&#xD;
        share their stress related to the Latinx experience, providing a safe space for participants&#xD;
        to process their stress and collectively practice stress management skills learned in&#xD;
        previous sessions. Session Eight aims to teach participants about advocacy, particularly&#xD;
        advocacy in schools, and provides school- and community-based resources meant to help&#xD;
        families navigate the school system. Session Nine focuses on financial wellness among&#xD;
        immigrant communities, including creating budgets and learning about financial resources,&#xD;
        including lending circles and financial aid. Session Ten is the culmination of FIESTA and&#xD;
        allows participants to share their successes with the group, review skills, and discuss any&#xD;
        linkages to resources. After Session 10, FIESTA will host a celebration where friends and&#xD;
        family have a chance to share in the successes of participants.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">October 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>This study will randomize 35 parent-youth dyads to the treatment arm or waitlist-control arm using block randomization. Each group will have 7-9 dyads, with two groups running simultaneously (treatment arm) and the remaining two groups running in three months (waitlist-control arm). After all participants are enrolled, families will be randomly selected to participate in either the treatment arm (immediate start) or waitlist-control arm (delayed start after 3 months).</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Hispanic Stress Inventory 2</measure>
      <time_frame>Baseline, 3 months, and 6 months</time_frame>
      <description>Self-reported (parent and youth) stress due to structural racism</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Perceived Stress Scale</measure>
      <time_frame>Baseline, 3 months, and 6 months</time_frame>
      <description>Self reported (parent and youth) daily stress</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Parent-Reported Outcome Measurement Information System Depression and Anxiety Short Form</measure>
      <time_frame>Baseline, 3 months, and 6 months</time_frame>
      <description>Self reported (parent and youth) depression and anxiety symptoms</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Brief Coping Orientation to Problems Experienced Inventory</measure>
      <time_frame>Baseline, 3 months, and 6 months</time_frame>
      <description>Self reported (parent and youth) individual coping</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Family Crisis Oriented Personal Evaluation Scales</measure>
      <time_frame>Baseline, 3 months, and 6 months</time_frame>
      <description>Self reported (parent and youth) family coping</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parent-Adolescent Communication Scale</measure>
      <time_frame>Baseline, 3 months, and 6 months</time_frame>
      <description>Self reported (parent and youth) parent-child relationship quality</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General Self-Efficacy Scale</measure>
      <time_frame>Baseline, 3 months, and 6 months</time_frame>
      <description>Self reported (parent and youth) empowerment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Knowledge of Resources</measure>
      <time_frame>Baseline, 3 months, and 6 months</time_frame>
      <description>Self reported (parent and youth) knowledge of resources in the community</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Implementation Interview</measure>
      <time_frame>Post-intervention (Time 2 for the treatment arm and Time 3 for the waitlist-control arm)</time_frame>
      <description>Self reported (parent and youth); a series of interview questions will be asked to assess the appropriateness, acceptability, and feasibility of FIESTA</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Stress, Psychological</condition>
    <condition>Mental Health Wellness</condition>
    <arm_group>
      <arm_group_label>Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in the treatment arm will begin the FIESTA intervention immediately (Time 1).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist-Control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants in the waitlist-control arm will wait approximately three months for the FIESTA intervention (Time 2).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Familias Inmigrantes Empoderándose contra eStrés Tomando Acción (FIESTA)</intervention_name>
      <description>FIESTA is a 10-session, group intervention led by community health workers that offers strategies related to individual stress management, family coping and communication, and community navigation.</description>
      <arm_group_label>Treatment</arm_group_label>
      <arm_group_label>Waitlist-Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Caregiver/Parent&#xD;
  &#xD;
            -  Identification as a Latina immigrant woman over the age of 18 years old&#xD;
  &#xD;
            -  Parent or primary caregiver of a youth between the ages of 14-17&#xD;
  &#xD;
          Youth&#xD;
  &#xD;
            -  Identification as a Latinx adolescent between the ages of 14-17&#xD;
  &#xD;
            -  Child of a primary caregiver (mother) who identifies as a Latina immigrant&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Adults and youth unable to cognitively participate in the group or adults who are&#xD;
               unable to consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Stephanie A Torres, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Illinois at Chicago</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Stephanie A Torres, PhD</last_name>
      <phone>312-996-7327</phone>
      <email>satorres@uic.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Illinois at Chicago</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60607</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Stephanie A Torres, PhD</last_name>
        <phone>312-996-7327</phone>
        <email>satorres@uic.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>immigrant families</keyword>
    <keyword>stress intervention</keyword>
    <keyword>structural racism</keyword>
    <keyword>latino</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stress, Psychological</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05991739
  org study id: 2022-0108
  secondary id: CTSA UL1TR002003
  nct id: NCT05991739
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate a new, community-based, group intervention called
        FIESTA (Familias Inmigrantes Empoderándose contra eStrés Tomando Acción) to understand how
        well it helps Latinx immigrant families deal with the impact of stress due to structural
        racism. Structural racism is defined as the policies, practices, and norms that work together
        to limit equal opportunities for minority communities. For Latinx immigrant families, this
        can include fears of deportation, lack of bilingual providers, and discrimination. These
        experiences of structural racism can turn into stress, which impacts well-being and mental
        health.
  
        Researchers will investigate if: 1) FIESTA lowers stress and mental health symptoms
        (anxiety/depression) and increases feelings of empowerment, improved knowledge of resources,
        better parent-youth relationship quality, and higher use of healthy coping skills; and 2)
        FIESTA is feasible (easy to carry out), acceptable (agreeable or satisfactory), and
        appropriate (relevant to the needs of Latinx families).
  
        FIESTA is ten-sessions and will be led by two community health workers. Researchers will
        enroll 35 parent-adolescent dyads (35 study-eligible parents and 35 study-eligible youth) in
        the initial study. This study will randomize parent-youth dyads to the treatment arm or
        waitlist-control arm using block randomization. In other words, participants will be randomly
        assigned to one of two groups, the First Group, or the Second Group. The First Group will
        begin immediately, and the Second Group will begin after three months. Data will be collected
        at baseline and three- and six-month post-baseline.
  The aim of the study is to pilot test a new, evidence-informed group intervention (FIESTA)
        among Latina immigrant mothers and youth (ages 14-17) and determine preliminary evidence as
        well as acceptability, appropriateness, and feasibility. FIESTA was developed in
        collaboration with a local community-based organization, the research team's established
        community partner.
  
        Participants will be recruited through the research team's established community partnership.
        To participate in FIESTA, both the caregiver and child are required to participate.
        Researchers will enroll 35 parent-adolescent dyads (35 study-eligible parents and 35
        study-eligible youth) in the initial pilot study. This study will randomize parent-youth
        dyads to the treatment arm or waitlist-control arm using block randomization. Each group will
        have 7-9 dyads, with two groups running simultaneously (treatment arm) and the remaining two
        groups running in three months (waitlist-control arm). After all participants are enrolled,
        families will be randomly selected to participate in either the treatment arm (immediate
        start) or waitlist-control arm (delayed start after 3 months). Participants in the treatment
        arm will begin the intervention immediately (Time 1) and the waitlist-control arm will wait
        approximately three months for the intervention (Time 2). All participants will be reassessed
        at Time 2 (after 3-months) and again at Time 3 (after 6-months), once the wait-control group
        has completed the intervention. After the intervention (Time 2 for the treatment arm and Time
        3 for the waitlist-control arm), participants will be asked a series of questions about the
        FIESTA intervention to assess for appropriateness, acceptability, and feasibility. All data
        collection will be completed by the research team.
  
        Each FIESTA group will be led by two community health workers who will not be involved in the
        research and will not know who participates in the study. The community health workers will
        meet the following criteria: 1) have participated in a leadership role at the community-based
        organization or an affiliated organization for at least one year; 2) have experience
        facilitating at least one workshop; and 3) attend and participate in a three-day training for
        FIESTA led by the PI.
  
        Each FIESTA session is two hours and will occur over ten weeks. FIESTA covers strategies
        related to individual stress management, family coping and communication, and community
        navigation. Throughout the sessions, there is an emphasis on sharing community-based
        resources if parents or youth are interested in obtaining future services. Each session will
        run parent and youth groups simultaneously, with a parent-youth activity built into each
        session. Parent and youth groups will be delivered separately to allow for a private space to
        discuss sensitive topics and practice skills. Material delivered to youth has been
        developmentally tailored. Session One provides participants with psychoeducation of stress,
        including the behavioral, emotional, and cognitive signs of stress, and focuses on
        recognizing stressors within Latinx communities. Session Two focuses on introducing the
        cognitive triangle and encourages participants to identify how their feelings, thoughts, and
        behaviors are connected. Participants will also learn evidence-based relaxation and
        mindfulness techniques that they will practice throughout the remainder of the sessions.
        Session Three teaches challenging negative thoughts and problem-solving techniques, using
        vignettes geared towards Latinx families (e.g., navigating language constraints at work).
        Session Four focuses on improving communication between parents and their children by
        teaching "I statements" and active listening through a series of role plays. Session Five is
        facilitated by an outside consultant recommended by the community partner and teaches about
        empowerment, the relationship between empowerment and self-esteem, and recognition of
        internal strengths and external support systems. Session Six focuses on principles developed
        from Know Your Rights trainings, including understanding rights when interacting with ICE and
        police and how to create a family emergency plan. Session Seven encourages participants to
        share their stress related to the Latinx experience, providing a safe space for participants
        to process their stress and collectively practice stress management skills learned in
        previous sessions. Session Eight aims to teach participants about advocacy, particularly
        advocacy in schools, and provides school- and community-based resources meant to help
        families navigate the school system. Session Nine focuses on financial wellness among
        immigrant communities, including creating budgets and learning about financial resources,
        including lending circles and financial aid. Session Ten is the culmination of FIESTA and
        allows participants to share their successes with the group, review skills, and discuss any
        linkages to resources. After Session 10, FIESTA will host a celebration where friends and
        family have a chance to share in the successes of participants.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study will randomize 35 parent-youth dyads to the treatment arm or waitlist-control arm using block randomization. Each group will have 7-9 dyads, with two groups running simultaneously (treatment arm) and the remaining two groups running in three months (waitlist-control arm). After all participants are enrolled, families will be randomly selected to participate in either the treatment arm (immediate start) or waitlist-control arm (delayed start after 3 months).
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Hispanic Stress Inventory 2
  time frame: Baseline, 3 months, and 6 months
  description: Self-reported (parent and youth) stress due to structural racism
  measure: Perceived Stress Scale
  time frame: Baseline, 3 months, and 6 months
  description: Self reported (parent and youth) daily stress
  measure: Parent-Reported Outcome Measurement Information System Depression and Anxiety Short Form
  time frame: Baseline, 3 months, and 6 months
  description: Self reported (parent and youth) depression and anxiety symptoms
  measure: Brief Coping Orientation to Problems Experienced Inventory
  time frame: Baseline, 3 months, and 6 months
  description: Self reported (parent and youth) individual coping
  measure: Family Crisis Oriented Personal Evaluation Scales
  time frame: Baseline, 3 months, and 6 months
  description: Self reported (parent and youth) family coping
  measure: Parent-Adolescent Communication Scale
  time frame: Baseline, 3 months, and 6 months
  description: Self reported (parent and youth) parent-child relationship quality
  measure: General Self-Efficacy Scale
  time frame: Baseline, 3 months, and 6 months
  description: Self reported (parent and youth) empowerment
  measure: Knowledge of Resources
  time frame: Baseline, 3 months, and 6 months
  description: Self reported (parent and youth) knowledge of resources in the community
  measure: Implementation Interview
  time frame: Post-intervention (Time 2 for the treatment arm and Time 3 for the waitlist-control arm)
  description: Self reported (parent and youth); a series of interview questions will be asked to assess the appropriateness, acceptability, and feasibility of FIESTA
  arm group label: Treatment
  arm group type: Experimental
  description: Participants in the treatment arm will begin the FIESTA intervention immediately (Time 1).
  arm group label: Waitlist-Control
  arm group type: Other
  description: Participants in the waitlist-control arm will wait approximately three months for the FIESTA intervention (Time 2).
  intervention type: Behavioral
  intervention name: Familias Inmigrantes Empoderándose contra eStrés Tomando Acción (FIESTA)
  description: FIESTA is a 10-session, group intervention led by community health workers that offers strategies related to individual stress management, family coping and communication, and community navigation.
  arm group label: Treatment
  arm group label: Waitlist-Control
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 17 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Stephanie A Torres, PhD
  role: Principal Investigator
  affiliation: University of Illinois at Chicago
  last name: Stephanie A Torres, PhD
  phone: 312-996-7327
  email: satorres@uic.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Stress, Psychological
  sharing ipd: No