<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/NCT03801408</url>
  </required_header>
  <id_info>
    <org_study_id>228929</org_study_id>
    <nct_id>NCT03801408</nct_id>
  </id_info>
  <brief_title>Building Partnerships With First Responders to Improve Delivery and Access of Mental Health Services</brief_title>
  <official_title>Building Partnerships With First Responders to Explore Strategies to Improve Delivery and Access of Mental Health Services</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arkansas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arkansas</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 conduct qualitative interviews with firefighters and EMTs/ paramedics across&#xD;
      Arkansas. To address this aim, opt-in methods will be used to recruit a diverse group of&#xD;
      firefighters and emergency medical technicians/paramedics from across Arkansas to participate&#xD;
      in qualitative interviews, defined as focus groups and individual interviews. Through this&#xD;
      work, this will generate the scientific foundation to develop a comprehensive, mental health&#xD;
      service model that will motivate engagement in services by diverse first responders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Firefighters and emergency medical technicians (EMTs)/ paramedics respond to more than 50&#xD;
      million emergency calls in the U.S. every year. The daily operations and experiences that are&#xD;
      expected and accepted as part of their job expose them to various traumatic events. The&#xD;
      nature, frequency, and intensity of duty-related traumatic exposures place these first&#xD;
      responders (FRs) at significant risk for mental health (MH) problems, such as post-traumatic&#xD;
      stress disorder (PTSD) and suicide. However, due to the stigma of mental illness and the&#xD;
      culture of self-reliance and strength that surrounds FRs, few are willing to seek help. There&#xD;
      will be a two-stage exploratory, qualitative study that will use a statewide&#xD;
      community-engagement approach to conceptualize a MH service model that would motivate FRs to&#xD;
      be more engaged in services. In Stage 1, qualitative interviews with firefighters and EMTs/&#xD;
      paramedics will be conducted across Arkansas. In Stage 2, product development process&#xD;
      grounded in these findings to conceptualize a MH service model feasible for implementation in&#xD;
      real world settings. (Protocol for Stage 2 will be submitted for IRB approval at a later&#xD;
      time.) Stage 1, Specific Aim: Identify FRs' preferences and priorities regarding MH service&#xD;
      and delivery methods, including the feasibility, acceptability, and value of each method. To&#xD;
      address this aim, we will use opt-in methods to recruit a diverse group of firefighters and&#xD;
      EMTs/paramedics from across Arkansas to participate in qualitative interviews, defined as&#xD;
      focus groups and individual interviews. After all qualitative interviews have been analyzed,&#xD;
      a series of product development activities in Stage 2. Through this work, the scientific&#xD;
      foundation to develop a comprehensive, MH service model that will motivate engagement in&#xD;
      services by diverse FRs. This study's findings will guide a multi-stage, research agenda that&#xD;
      will include development and pilot testing of the MH service model, ultimately, promoting&#xD;
      engagement in MH services may decrease suicide rates and improve the overall MH outcomes&#xD;
      among this at-risk population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">September 25, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>First Responders Who Provided Qualitative Data</measure>
    <time_frame>1.5 year</time_frame>
    <description>Number of first responders who provided perspectives and/or priorities for mental health services and/or provided suggestions for how to adapt this feedback to the population.</description>
  </primary_outcome>
  <enrollment type="Actual">145</enrollment>
  <condition>Mental Health Wellness 1</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Firefighters and EMT/paramedics in Arkansas&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ages 18 and over volunteer and career personnel active, inactive, and retired&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non- English speaking (due to the nature of focus group/interview discussions)&#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>Sara Jones, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arkansas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <results_first_submitted>September 21, 2021</results_first_submitted>
  <results_first_submitted_qc>October 18, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 16, 2021</results_first_posted>
  <last_update_submitted>October 18, 2021</last_update_submitted>
  <last_update_submitted_qc>October 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03801408/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>We used opt-in methods, facilitated by our community partners, to recruit. The PI visited fire departments and EMS stations. The State EMS Director distributed information through the state EMS registry. Emails and promotional materials instructed first responders to contact the PI or research assistant by telephone or email for more study information. The PI was invited to present and recruit at state fire and EMS meetings. The study flyer was also placed on social media sites.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Arkansas First Responders</title>
          <description>All participants were current or retired first responders in Arkansas, including certified Emergency Responders, Emergency Medical Technicians, Paramedics, and Firefighters.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="145"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="145"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Arkansas First Responders</title>
          <description>All participants were current or retired first responders in Arkansas, including certified Emergency Responders, Emergency Medical Technicians, Paramedics, and Firefighters.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="145"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="135"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="144"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="133"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Military experience</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Current military experience</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Past military experience (veteran)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No military experience</title>
                  <measurement_list>
                    <measurement group_id="B1" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Department size</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Small (3 or less stations)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Medium (More than 3 stations, less than 150 people)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Large (More than 150 people)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not answered</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Department setting</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Rural</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Suburban</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Urban</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mixed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Previous treatment for mental health</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="110"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not answered</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>First Responders Who Provided Qualitative Data</title>
        <description>Number of first responders who provided perspectives and/or priorities for mental health services and/or provided suggestions for how to adapt this feedback to the population.</description>
        <time_frame>1.5 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arkansas First Responders</title>
            <description>All participants were current or retired first responders in Arkansas, including certified Emergency Responders, Emergency Medical Technicians, Paramedics, and Firefighters.</description>
          </group>
        </group_list>
        <measure>
          <title>First Responders Who Provided Qualitative Data</title>
          <description>Number of first responders who provided perspectives and/or priorities for mental health services and/or provided suggestions for how to adapt this feedback to the population.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="145"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1.5 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Arkansas First Responders</title>
          <description>All participants were current or retired first responders in Arkansas, including certified Emergency Responders, Emergency Medical Technicians, Paramedics, and Firefighters.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="145"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="145"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="145"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Sara Jones, Principal Investigator</name_or_title>
      <organization>University of Arkansas for Medical Sciences</organization>
      <phone>501-526-7846</phone>
      <email>sljones@uams.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03801408
org study id: 228929
nct id: NCT03801408
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will conduct qualitative interviews with firefighters and EMTs/ paramedics across
      Arkansas. To address this aim, opt-in methods will be used to recruit a diverse group of
      firefighters and emergency medical technicians/paramedics from across Arkansas to participate
      in qualitative interviews, defined as focus groups and individual interviews. Through this
      work, this will generate the scientific foundation to develop a comprehensive, mental health
      service model that will motivate engagement in services by diverse first responders.
Firefighters and emergency medical technicians (EMTs)/ paramedics respond to more than 50
      million emergency calls in the U.S. every year. The daily operations and experiences that are
      expected and accepted as part of their job expose them to various traumatic events. The
      nature, frequency, and intensity of duty-related traumatic exposures place these first
      responders (FRs) at significant risk for mental health (MH) problems, such as post-traumatic
      stress disorder (PTSD) and suicide. However, due to the stigma of mental illness and the
      culture of self-reliance and strength that surrounds FRs, few are willing to seek help. There
      will be a two-stage exploratory, qualitative study that will use a statewide
      community-engagement approach to conceptualize a MH service model that would motivate FRs to
      be more engaged in services. In Stage 1, qualitative interviews with firefighters and EMTs/
      paramedics will be conducted across Arkansas. In Stage 2, product development process
      grounded in these findings to conceptualize a MH service model feasible for implementation in
      real world settings. (Protocol for Stage 2 will be submitted for IRB approval at a later
      time.) Stage 1, Specific Aim: Identify FRs' preferences and priorities regarding MH service
      and delivery methods, including the feasibility, acceptability, and value of each method. To
      address this aim, we will use opt-in methods to recruit a diverse group of firefighters and
      EMTs/paramedics from across Arkansas to participate in qualitative interviews, defined as
      focus groups and individual interviews. After all qualitative interviews have been analyzed,
      a series of product development activities in Stage 2. Through this work, the scientific
      foundation to develop a comprehensive, MH service model that will motivate engagement in
      services by diverse FRs. This study's findings will guide a multi-stage, research agenda that
      will include development and pilot testing of the MH service model, ultimately, promoting
      engagement in MH services may decrease suicide rates and improve the overall MH outcomes
      among this at-risk population.
observational model: Other
time perspective: Other
measure: First Responders Who Provided Qualitative Data
time frame: 1.5 year
description: Number of first responders who provided perspectives and/or priorities for mental health services and/or provided suggestions for how to adapt this feedback to the population.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sara Jones, PhD
role: Principal Investigator
affiliation: University of Arkansas
facility: 
country: United States
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 