<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/NCT03755206</url>
  </required_header>
  <id_info>
    <org_study_id>JHSPH_sustains</org_study_id>
    <nct_id>NCT03755206</nct_id>
  </id_info>
  <brief_title>Sust-AIns: Sustainment of Suicide Prevention Programs in American Indian Settings</brief_title>
  <acronym>Sust-AIns</acronym>
  <official_title>Sust-AIns: Sustainment of Suicide Prevention Programs in American Indian Settings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins Bloomberg School of Public Health</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 proposed study is part of the research project for a National Institute of Mental Health&#xD;
      K01 grant to Dr. Haroz. The overall research project is focused on understanding how to&#xD;
      sustain evidenced-based mental and behavioral health programs in tribal contexts. The aim of&#xD;
      this study is to pilot test sustainment strategy interventions across tribal settings using&#xD;
      mixed-methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Among the most pressing issues in mental health Dissemination and Implementation research&#xD;
      (D&amp;I) is the lack of knowledge about how to sustain mental health prevention and treatment&#xD;
      services for which there is substantial evidence of impact. Most D&amp;I studies focus on&#xD;
      adoption and initial implementation, with few studies (&lt;20) rigorously exploring sustainment.&#xD;
      The sustainment of services has been described as &quot;one of the greatest, yet least understood,&#xD;
      challenges in the field of implementation science.&quot; The gap in knowledge is even greater for&#xD;
      low-resource contexts, as few studies have focused on these settings. This project aims to&#xD;
      address this gap by developing and testing sustainment strategies for an evidenced-based&#xD;
      youth suicide prevention program in a low-resource, American Indian (AI) contexts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">December 10, 2018</start_date>
  <completion_date type="Anticipated">May 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 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>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>Program Sustainability Assessment Tool</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Tool that assess domains of capacity for sustainability</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">28</enrollment>
  <condition>Program Sustainability</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Interrupted time series design</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sustainability strategies</intervention_name>
    <description>The investigators will work with each site to determine strategies that are relevant locally to help promote sustainability of the suicide prevention program.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Knowledgeable about the implementation of the suicide prevention program&#xD;
&#xD;
          -  Over the age of 18&#xD;
&#xD;
          -  Available to participate in required study meetings and assessments&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Factors identified at baseline that preclude full participation including: being under&#xD;
             the influence of a substance; active psychosis or mania; any other condition that&#xD;
             makes an individual lack capacity to give consent.&#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>Emily E. Haroz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Online Survey</name>
      <address>
        <city>Whiteriver</city>
        <state>Arizona</state>
        <zip>85941</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>February 21, 2023</last_update_submitted>
  <last_update_submitted_qc>February 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Suicide Prevention</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/NCT03755206
org study id: JHSPH_sustains
nct id: NCT03755206
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed study is part of the research project for a National Institute of Mental Health
      K01 grant to Dr. Haroz. The overall research project is focused on understanding how to
      sustain evidenced-based mental and behavioral health programs in tribal contexts. The aim of
      this study is to pilot test sustainment strategy interventions across tribal settings using
      mixed-methods.
Among the most pressing issues in mental health Dissemination and Implementation research
      (D&I) is the lack of knowledge about how to sustain mental health prevention and treatment
      services for which there is substantial evidence of impact. Most D&I studies focus on
      adoption and initial implementation, with few studies (<20) rigorously exploring sustainment.
      The sustainment of services has been described as "one of the greatest, yet least understood,
      challenges in the field of implementation science." The gap in knowledge is even greater for
      low-resource contexts, as few studies have focused on these settings. This project aims to
      address this gap by developing and testing sustainment strategies for an evidenced-based
      youth suicide prevention program in a low-resource, American Indian (AI) contexts.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Program Sustainability Assessment Tool
time frame: up to 5 years
description: Tool that assess domains of capacity for sustainability
arm group label: Intervention
arm group type: Other
description: Interrupted time series design
intervention type: Other
intervention name: Sustainability strategies
description: The investigators will work with each site to determine strategies that are relevant locally to help promote sustainability of the suicide prevention program.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emily E. Haroz, PhD
role: Principal Investigator
affiliation: Johns Hopkins Bloomberg School of Public Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Suicide
mesh term: Suicide Prevention
sharing ipd: No