<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/NCT04506437</url>
  </required_header>
  <id_info>
    <org_study_id>1R34MH119433-01A1</org_study_id>
    <secondary_id>1R34MH119433-01A1</secondary_id>
    <nct_id>NCT04506437</nct_id>
  </id_info>
  <brief_title>Foster Care Mental Health Family Navigator</brief_title>
  <acronym>FCFN</acronym>
  <official_title>Foster Care Mental Health Family Navigator</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study will focus on developing and testing a family-based mental health navigator&#xD;
      intervention, the Foster Care Family Navigator (FCFN), to evaluate whether the intervention&#xD;
      combined with mHealth would be efficacious in improving mental health service initiation and&#xD;
      engagement for child welfare-involved youth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will demonstrate how a family-based navigator intervention combined with mHealth&#xD;
      may lead to improved mental health treatment initiation and engagement among child&#xD;
      welfare-involved (CWI) youth. CWI youth have high rates of mental health symptoms relative to&#xD;
      youth in the community, and are disproportionately racial and ethnic minorities, only&#xD;
      perpetuating disparities in this population's mental health access and engagement. The&#xD;
      proposed project will develop and test a family-based navigator intervention, the Foster Care&#xD;
      Family Navigator (FCFN), a natural fit for improving CWI youth mental health service and&#xD;
      clinical outcomes. The study will start with identifying the feasibility and acceptability of&#xD;
      the FCFN intervention. Then, the study will determine whether the FCFN intervention improves&#xD;
      CWI youth mental health treatment initiation and engagement, relative to standard of care&#xD;
      (not participating in FCFN intervention). Finally, the study will characterize patterns of&#xD;
      pre- and post-service outcomes along the behavioral health services cascade of care, to&#xD;
      further evaluate the feasibility, acceptability, and preliminary impact of the FCFN model.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 20, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 31, 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 is a dynamic wait-listed design in which the investigators will test a theory-driven family-based navigator treatment engagement intervention (FCFN) while also collecting data on the FCFN model's potential implementation and adoption within child welfare and behavioral health settings.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to treatment referral</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>Number of days until treatment referral is made</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to treatment initiation</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>Number of days until attendance at first treatment session</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment engagement</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>Engagement as measured by attendance in treatment for 6 or more weeks</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">125</enrollment>
  <condition>Mental Health</condition>
  <arm_group>
    <arm_group_label>Family-based mental health navigation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care, then family-based mental health navigation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During wait-list period receive standard of care engagement practices and services-as-usual, and after the wait-list period the participants receive the family-based navigator intervention combined with mHealth practices</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Family-based mental health navigation</intervention_name>
    <description>Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement</description>
    <arm_group_label>Family-based mental health navigation</arm_group_label>
    <arm_group_label>Standard of care, then family-based mental health navigation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of care engagement practices</intervention_name>
    <description>Standard of care engagement practices and services-as-usual</description>
    <arm_group_label>Standard of care, then family-based mental health navigation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English-speaking youth&#xD;
&#xD;
          -  Ages 12-17&#xD;
&#xD;
          -  Have an active dependency petition with the SF Unified Family Court (newly filed or&#xD;
             existing when the trial starts)&#xD;
&#xD;
          -  Are open to SF DPH Foster Care Mental Health Clinic services&#xD;
&#xD;
          -  Have an involved caregiver/legal guardian for consent&#xD;
&#xD;
          -  Family has mobile phone access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Youth is not English-speaking&#xD;
&#xD;
          -  Caregiver has impairment that would preclude providing informed consent&#xD;
&#xD;
          -  Unavailable guardian for consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marina Tolou-Shams, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>UC San Francisco</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marina Tolou-Shams, Ph.D</last_name>
    <phone>628-206-2212</phone>
    <email>marina.tolou-shams@ucsf.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lakshmi Gopalakrishnan, MSc</last_name>
    <phone>415-509-5999</phone>
    <email>lakshmi.gopalakrishnan@ucsf.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UCSF Zuckerberg San Francisco General Hospital</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94131</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marina Tolou-Shams, PhD</last_name>
      <phone>628-206-2212</phone>
      <email>marina.tolou-shams@ucsf.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adolescent</keyword>
  <keyword>Foster Care</keyword>
  <keyword>Mental Health</keyword>
  <keyword>Navigator</keyword>
  <keyword>Service Access</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/NCT04506437
org study id: 1R34MH119433-01A1
secondary id: 1R34MH119433-01A1
nct id: NCT04506437
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will focus on developing and testing a family-based mental health navigator
      intervention, the Foster Care Family Navigator (FCFN), to evaluate whether the intervention
      combined with mHealth would be efficacious in improving mental health service initiation and
      engagement for child welfare-involved youth.
The study will demonstrate how a family-based navigator intervention combined with mHealth
      may lead to improved mental health treatment initiation and engagement among child
      welfare-involved (CWI) youth. CWI youth have high rates of mental health symptoms relative to
      youth in the community, and are disproportionately racial and ethnic minorities, only
      perpetuating disparities in this population's mental health access and engagement. The
      proposed project will develop and test a family-based navigator intervention, the Foster Care
      Family Navigator (FCFN), a natural fit for improving CWI youth mental health service and
      clinical outcomes. The study will start with identifying the feasibility and acceptability of
      the FCFN intervention. Then, the study will determine whether the FCFN intervention improves
      CWI youth mental health treatment initiation and engagement, relative to standard of care
      (not participating in FCFN intervention). Finally, the study will characterize patterns of
      pre- and post-service outcomes along the behavioral health services cascade of care, to
      further evaluate the feasibility, acceptability, and preliminary impact of the FCFN model.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a dynamic wait-listed design in which the investigators will test a theory-driven family-based navigator treatment engagement intervention (FCFN) while also collecting data on the FCFN model's potential implementation and adoption within child welfare and behavioral health settings.
primary purpose: Treatment
masking: None (Open Label)
measure: Time to treatment referral
time frame: 12 months post enrollment
description: Number of days until treatment referral is made
measure: Time to treatment initiation
time frame: 12 months post enrollment
description: Number of days until attendance at first treatment session
measure: Treatment engagement
time frame: 12 months post enrollment
description: Engagement as measured by attendance in treatment for 6 or more weeks
arm group label: Family-based mental health navigation
arm group type: Experimental
description: Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement
arm group label: Standard of care, then family-based mental health navigation
arm group type: Active Comparator
description: During wait-list period receive standard of care engagement practices and services-as-usual, and after the wait-list period the participants receive the family-based navigator intervention combined with mHealth practices
intervention type: Behavioral
intervention name: Family-based mental health navigation
description: Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement
arm group label: Family-based mental health navigation
arm group label: Standard of care, then family-based mental health navigation
intervention type: Behavioral
intervention name: Standard of care engagement practices
description: Standard of care engagement practices and services-as-usual
arm group label: Standard of care, then family-based mental health navigation
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
last name: Marina Tolou-Shams, Ph.D
role: Principal Investigator
affiliation: UC San Francisco
last name: Marina Tolou-Shams, Ph.D
phone: 628-206-2212
email: marina.tolou-shams@ucsf.edu
last name: Lakshmi Gopalakrishnan, MSc
phone: 415-509-5999
email: lakshmi.gopalakrishnan@ucsf.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
sharing ipd: No