<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/NCT03236766</url>
  </required_header>
  <id_info>
    <org_study_id>R21MH110814</org_study_id>
    <nct_id>NCT03236766</nct_id>
  </id_info>
  <brief_title>Engaging Pacific Islander Perspectives on Mental Illness and Mental Health Services</brief_title>
  <official_title>Engaging Pacific Islander Perspectives on Mental Illness and Mental Health Services</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Riverside</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Riverside</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>
      This study will enroll 100 Samoan and 100 Marshallese adults to discuss mental health, mental&#xD;
      disorders, and approaches for engaging Pacific Islander adults with mental illness into&#xD;
      mental health services.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite enduring high mental health burden, Pacific Islanders have received minimal research&#xD;
      or clinical attention in the US. Due to our poor understanding of the issues surrounding&#xD;
      Pacific Islander mental health, engaging Pacific Islanders in mental health services has been&#xD;
      very difficult.&#xD;
&#xD;
      This study draws from the Cultural Determinants of Help-Seeking Model to address this&#xD;
      research and clinical gap by conducting focus groups and citizens' panels to obtain public&#xD;
      input from 50 Samoans in LAC and 50 Marshallese in Arkansas on their unique mental health&#xD;
      perspectives, needs, barriers and facilitators to services, and strategies to overcome these&#xD;
      barriers. The citizens' panels will bring together lay public members, present multiple&#xD;
      viewpoints about various mental health issues, and have members deliberate and reach a&#xD;
      collective decision on these issues. All group materials will be translated into English,&#xD;
      Samoan, and Marshallese, and interpreters will be present during the sessions. The groups&#xD;
      will be audio-recorded, transcribed verbatim, and analyzed by the Research Team for themes.&#xD;
      Numerical data will also be collected about levels of public awareness about mental illness,&#xD;
      mental health stigma, acculturation, and underutilization of mental health services from 100&#xD;
      Samoan and 100 Marshallese community members to better understand these possible service&#xD;
      barriers.&#xD;
&#xD;
      Analyzed data will be used to develop a set of intervention components that are likely to&#xD;
      increase service engagement among both Samoans and Marshallese. These components will provide&#xD;
      the foundation for a universal service engagement intervention for Pacific Islanders that&#xD;
      will be developed and tested in future research.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No intervention or clinical trial necessitating participants ultimately needed or required for&#xD;
    this study.&#xD;
  </why_stopped>
  <start_date type="Actual">September 30, 2017</start_date>
  <completion_date type="Actual">March 30, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants participating in study</measure>
    <time_frame>Up to 20 months</time_frame>
    <description>There is no primary quantitative outcome beyond increased knowledge of Pacific Islander mental health beliefs and treatment preferences</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Mental Disorder</condition>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Citizens' panels</intervention_name>
    <description>This study is exploratory in nature, designed to capture lay Pacific Islanders' thoughts and beliefs about existing service engagement approaches. Therefore, there are no study arms to list.</description>
    <arm_group_label>No intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Samoan or Marshallese heritage; living in Los Angeles County or Northwest Arkansas;&#xD;
             age 18 years or older; English, Samoan, or Marshallese oral and reading fluency&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not of Samoan or Marshallese heritage; living outside the catchment areas; younger&#xD;
             than 18 years; not fluent in English, Samoan, or Marshallese&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Riverside</investigator_affiliation>
    <investigator_full_name>Andrew Subica</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <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/NCT03236766
org study id: R21MH110814
nct id: NCT03236766
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will enroll 100 Samoan and 100 Marshallese adults to discuss mental health, mental
      disorders, and approaches for engaging Pacific Islander adults with mental illness into
      mental health services.
Despite enduring high mental health burden, Pacific Islanders have received minimal research
      or clinical attention in the US. Due to our poor understanding of the issues surrounding
      Pacific Islander mental health, engaging Pacific Islanders in mental health services has been
      very difficult.

      This study draws from the Cultural Determinants of Help-Seeking Model to address this
      research and clinical gap by conducting focus groups and citizens' panels to obtain public
      input from 50 Samoans in LAC and 50 Marshallese in Arkansas on their unique mental health
      perspectives, needs, barriers and facilitators to services, and strategies to overcome these
      barriers. The citizens' panels will bring together lay public members, present multiple
      viewpoints about various mental health issues, and have members deliberate and reach a
      collective decision on these issues. All group materials will be translated into English,
      Samoan, and Marshallese, and interpreters will be present during the sessions. The groups
      will be audio-recorded, transcribed verbatim, and analyzed by the Research Team for themes.
      Numerical data will also be collected about levels of public awareness about mental illness,
      mental health stigma, acculturation, and underutilization of mental health services from 100
      Samoan and 100 Marshallese community members to better understand these possible service
      barriers.

      Analyzed data will be used to develop a set of intervention components that are likely to
      increase service engagement among both Samoans and Marshallese. These components will provide
      the foundation for a universal service engagement intervention for Pacific Islanders that
      will be developed and tested in future research.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of participants participating in study
time frame: Up to 20 months
description: There is no primary quantitative outcome beyond increased knowledge of Pacific Islander mental health beliefs and treatment preferences
arm group label: No intervention
arm group type: Other
intervention type: Other
intervention name: Citizens' panels
description: This study is exploratory in nature, designed to capture lay Pacific Islanders' thoughts and beliefs about existing service engagement approaches. Therefore, there are no study arms to list.
arm group label: No intervention
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of California, Riverside
investigator full name: Andrew Subica
investigator title: Assistant Professor
mesh term: Mental Disorders
sharing ipd: No