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/NCT05973942</url>
    </required_header>
    <id_info>
      <org_study_id>8550</org_study_id>
      <nct_id>NCT05973942</nct_id>
    </id_info>
    <brief_title>Population Impact of Wingman-Connect Implemented by the US Air Force</brief_title>
    <official_title>Population Impact of Wingman-Connect Implemented by the US Air Force</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Rochester</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Rochester</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 involves collection of implementation data and analysis of USAF de-identified&#xD;
        administrative data on base-level suicide attempt rates following US Air Force (USAF)&#xD;
        delivery of Wingman-Connect training at 8 operational AF bases, as part of a force-wide scale&#xD;
        out of the program. Implementation of Wingman-Connect by the USAF will occur over 51 months.&#xD;
        The AF has agreed to stagger implementation based on a randomized stepped-wedge design. Once&#xD;
        Wingman-Connect has been initiated at each base, all entering first-term Airmen will receive&#xD;
        Wingman-Connect, with ~17,400 total Airmen receiving Wingman-Connect across all bases.&#xD;
  &#xD;
        Implementation. The study will directly collect data from USAF prevention personnel who are&#xD;
        involved in the delivery of the intervention to measure fidelity and measure implementation&#xD;
        barriers and facilitators. These base-level data are essential to test Wingman-Connect impact&#xD;
        on suicide attempt rates in a general USAF population, to study Wingman-Connect diffusion,&#xD;
        and to refine implementation processes and tools.&#xD;
  &#xD;
        Suicide Rates. Bases routinely provide their base-wide suicide attempt rates to the Air Force&#xD;
        Medical Readiness Agency (AFMRA). AFMRA will provide these routinely-collected aggregate&#xD;
        administrative data to this study in order to analyze changes in base-level suicide attempt&#xD;
        rates (USAF administrative data) among the 8 bases.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The US Air Force is putting into regular practice the Wingman-Connect Program (Wyman et al,&#xD;
        2020) in the context of First Term Airmen Courses (FTAC) across all 68 operational bases,&#xD;
        beginning with 8 bases in two Major Commands (AFGSC, AMC). University of Rochester&#xD;
        researchers will provide facilitator training and ongoing fidelity monitoring.&#xD;
        Wingman-Connect uses a network health theoretical framework to strengthen two&#xD;
        suicide-protective functions of social networks: 1) Strengthening positive social bonds, and&#xD;
        2) Building healthy norms that incentivize adaptive coping (Wyman et al, 2022).&#xD;
        Implementation of Wingman-Connect by the USAF will occur over 51 months. The AF has agreed to&#xD;
        stagger implementation based on a randomized stepped-wedge design. Pairs of bases will begin&#xD;
        implementation of the program in all FTAC at 3 months intervals and continue over a 51 month&#xD;
        total period. Data collection will begin with the start of implementation at each base.&#xD;
  &#xD;
        Implementation. The study will directly collect data from USAF prevention personnel who are&#xD;
        involved in the delivery of the intervention to measure fidelity and measure implementation&#xD;
        barriers and facilitators at each location. Prevention personnel will complete measures every&#xD;
        6 months. Due to turnover of personnel (training site administrators every 6 months) we&#xD;
        anticipate 8-12 individual respondents per site across the study period, and 4-6 respondents&#xD;
        at each site per data point, for a possible total of N=96 respondents. These participants are&#xD;
        also expected to reflect the demographics of the USAF as a whole. Measures will include base&#xD;
        climate, uptake of program, USAF implementers' fidelity delivering Wingman-Connect and&#xD;
        engagement in training/technical support.&#xD;
  &#xD;
        Suicide Rates. Bases routinely provide their base-wide suicide attempt rates to the Air Force&#xD;
        Medical Readiness Agency (AFMRA). To test effectiveness of Wingman-Connect delivered by the&#xD;
        USAF on these bases, the AFMRA will provide these routinely-collected aggregate&#xD;
        administrative data to this study in order to analyze changes in base-level suicide attempt&#xD;
        rates (USAF administrative data) among the 8 bases. AFMRA will provide suicide attempt and&#xD;
        suicidal behavior data for Airmen of E1-E4 ranks (incoming first term Airmen) on each base&#xD;
        every 6 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">June 1, 2024</start_date>
    <completion_date type="Anticipated">August 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2027</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>Sequential Assignment</intervention_model>
      <intervention_model_description>Stepped Wedge. The US Air Force is implementing Wingman-Connect (Wyman et al, 2020) in collaboration with University of Rochester researchers in the context of First Term Airmen Classes (FTAC) across 8 operational bases. The AF has agreed to stagger implementation based on randomization informed by a stepped-wedge design. Wingman-Connect training will be rolled out at 8 USAF bases in pairs at 3 month intervals and will continue for a total of 51 months.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Total Base level suicide attempts among Ranks E1-4</measure>
      <time_frame>4 years</time_frame>
      <description>Suicide attempt data for the total population of junior Airmen on each base will be collected from the Air Force Medical Readiness Agency (AFMRA) through our study sponsor Office of Integrated Resilience (HAF/A1Z). Suicide attempt data is compiled using ICD-10 codes for patient encounters across multiple sources including records from direct-care within Air Force medical systems (CAPER, SIDR, M2).</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">17400</enrollment>
    <condition>Suicide Prevention</condition>
    <arm_group>
      <arm_group_label>Wingman-Connect</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Wingman-Connect (Wyman et al., 2020) uses a network health theoretical framework to strengthen two suicide-protective functions of social networks: 1) Strengthening positive social bonds, and 2) Building healthy norms that incentivize adaptive coping. Training will be delivered in First Term Airmen classes among all Airmen arriving at base during the study period.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Wingman-Connect</intervention_name>
      <description>Training occurs in three 2-hr blocks over several days. Targeted Skills focus on protective factors (Four Cores) supportive of mental health, theoretically linked to reduced suicide risk, and essential to an Airmen's job success: (1) Healthy relationships and accountability spanning USAF and family/intimate relationships (Kinship); (2) Meaning and value in work and life (Purpose), (3) Informal and formal help-seeking (Guidance); and (4) Activities that give strength and balance emotions (Balance). Activities progress from individual to group skill-building activities. Kinship modules at operational base (FTAC) expand focus on growing and sustaining relationships with intimate partners, friends, and family; and Guidance more on senior mentors at work.</description>
      <arm_group_label>Wingman-Connect</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Data from bases in the Air Force Global Strike Command (AFGSC) &amp; Air Mobility Command&#xD;
               (AMC) MajComs.&#xD;
  &#xD;
            -  96 implementers (4-5 per base over at each data point, and 8-12 respondents per site&#xD;
               across the study period)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  none&#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_contact>
      <last_name>Peter A Wyman, PhD</last_name>
      <phone>585-273-3372</phone>
      <email>Peter_wyman@urmc.rochester.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Bryan Yates, BS</last_name>
      <phone>585-276-4082</phone>
      <email>bryan_yates@urmc.rochester.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Rochester</name>
        <address>
          <city>Rochester</city>
          <state>New York</state>
          <zip>14642</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Wyman PA, Pickering TA, Pisani AR, Cero I, Yates B, Schmeelk-Cone K, Hendricks Brown C, Gibbons RD, Simonson J, Pflanz SE. Wingman-Connect Program increases social integration for Air Force personnel at elevated suicide risk: Social network analysis of a cluster RCT. Soc Sci Med. 2022 Mar;296:114737. doi: 10.1016/j.socscimed.2022.114737. Epub 2022 Jan 22.</citation>
      <PMID>35131614</PMID>
    </reference>
    <reference>
      <citation>Wyman PA, Pisani AR, Brown CH, Yates B, Morgan-DeVelder L, Schmeelk-Cone K, Gibbons RD, Caine ED, Petrova M, Neal-Walden T, Linkh DJ, Matteson A, Simonson J, Pflanz SE. Effect of the Wingman-Connect Upstream Suicide Prevention Program for Air Force Personnel in Training: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2022532. doi: 10.1001/jamanetworkopen.2020.22532.</citation>
      <PMID>33084901</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Rochester</investigator_affiliation>
      <investigator_full_name>Peter Wyman</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>military</keyword>
    <keyword>suicide rates</keyword>
    <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>Yes</sharing_ipd>
      <ipd_description>De-identified data on base-level suicide attempts will be made available at the NIMH Data Archive (NDA). Any coding used to manipulate data (create categories, scales) will be done in either SPSS or R and this code will also be provided via NDA or github.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>All data will be deposited to NDA starting 12 months after the award begins and will be deposited every six months thereafter following the usual NDA data submission dates.</ipd_time_frame>
      <ipd_access_criteria>To request access of the data, researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable.</ipd_access_criteria>
    </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/NCT05973942
  org study id: 8550
  nct id: NCT05973942
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study involves collection of implementation data and analysis of USAF de-identified
        administrative data on base-level suicide attempt rates following US Air Force (USAF)
        delivery of Wingman-Connect training at 8 operational AF bases, as part of a force-wide scale
        out of the program. Implementation of Wingman-Connect by the USAF will occur over 51 months.
        The AF has agreed to stagger implementation based on a randomized stepped-wedge design. Once
        Wingman-Connect has been initiated at each base, all entering first-term Airmen will receive
        Wingman-Connect, with ~17,400 total Airmen receiving Wingman-Connect across all bases.
  
        Implementation. The study will directly collect data from USAF prevention personnel who are
        involved in the delivery of the intervention to measure fidelity and measure implementation
        barriers and facilitators. These base-level data are essential to test Wingman-Connect impact
        on suicide attempt rates in a general USAF population, to study Wingman-Connect diffusion,
        and to refine implementation processes and tools.
  
        Suicide Rates. Bases routinely provide their base-wide suicide attempt rates to the Air Force
        Medical Readiness Agency (AFMRA). AFMRA will provide these routinely-collected aggregate
        administrative data to this study in order to analyze changes in base-level suicide attempt
        rates (USAF administrative data) among the 8 bases.
  The US Air Force is putting into regular practice the Wingman-Connect Program (Wyman et al,
        2020) in the context of First Term Airmen Courses (FTAC) across all 68 operational bases,
        beginning with 8 bases in two Major Commands (AFGSC, AMC). University of Rochester
        researchers will provide facilitator training and ongoing fidelity monitoring.
        Wingman-Connect uses a network health theoretical framework to strengthen two
        suicide-protective functions of social networks: 1) Strengthening positive social bonds, and
        2) Building healthy norms that incentivize adaptive coping (Wyman et al, 2022).
        Implementation of Wingman-Connect by the USAF will occur over 51 months. The AF has agreed to
        stagger implementation based on a randomized stepped-wedge design. Pairs of bases will begin
        implementation of the program in all FTAC at 3 months intervals and continue over a 51 month
        total period. Data collection will begin with the start of implementation at each base.
  
        Implementation. The study will directly collect data from USAF prevention personnel who are
        involved in the delivery of the intervention to measure fidelity and measure implementation
        barriers and facilitators at each location. Prevention personnel will complete measures every
        6 months. Due to turnover of personnel (training site administrators every 6 months) we
        anticipate 8-12 individual respondents per site across the study period, and 4-6 respondents
        at each site per data point, for a possible total of N=96 respondents. These participants are
        also expected to reflect the demographics of the USAF as a whole. Measures will include base
        climate, uptake of program, USAF implementers' fidelity delivering Wingman-Connect and
        engagement in training/technical support.
  
        Suicide Rates. Bases routinely provide their base-wide suicide attempt rates to the Air Force
        Medical Readiness Agency (AFMRA). To test effectiveness of Wingman-Connect delivered by the
        USAF on these bases, the AFMRA will provide these routinely-collected aggregate
        administrative data to this study in order to analyze changes in base-level suicide attempt
        rates (USAF administrative data) among the 8 bases. AFMRA will provide suicide attempt and
        suicidal behavior data for Airmen of E1-E4 ranks (incoming first term Airmen) on each base
        every 6 months.
  allocation: N/A
  intervention model: Sequential Assignment
  intervention model description: Stepped Wedge. The US Air Force is implementing Wingman-Connect (Wyman et al, 2020) in collaboration with University of Rochester researchers in the context of First Term Airmen Classes (FTAC) across 8 operational bases. The AF has agreed to stagger implementation based on randomization informed by a stepped-wedge design. Wingman-Connect training will be rolled out at 8 USAF bases in pairs at 3 month intervals and will continue for a total of 51 months.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Total Base level suicide attempts among Ranks E1-4
  time frame: 4 years
  description: Suicide attempt data for the total population of junior Airmen on each base will be collected from the Air Force Medical Readiness Agency (AFMRA) through our study sponsor Office of Integrated Resilience (HAF/A1Z). Suicide attempt data is compiled using ICD-10 codes for patient encounters across multiple sources including records from direct-care within Air Force medical systems (CAPER, SIDR, M2).
  arm group label: Wingman-Connect
  arm group type: Experimental
  description: Wingman-Connect (Wyman et al., 2020) uses a network health theoretical framework to strengthen two suicide-protective functions of social networks: 1) Strengthening positive social bonds, and 2) Building healthy norms that incentivize adaptive coping. Training will be delivered in First Term Airmen classes among all Airmen arriving at base during the study period.
  intervention type: Behavioral
  intervention name: Wingman-Connect
  description: Training occurs in three 2-hr blocks over several days. Targeted Skills focus on protective factors (Four Cores) supportive of mental health, theoretically linked to reduced suicide risk, and essential to an Airmen's job success: (1) Healthy relationships and accountability spanning USAF and family/intimate relationships (Kinship); (2) Meaning and value in work and life (Purpose), (3) Informal and formal help-seeking (Guidance); and (4) Activities that give strength and balance emotions (Balance). Activities progress from individual to group skill-building activities. Kinship modules at operational base (FTAC) expand focus on growing and sustaining relationships with intimate partners, friends, and family; and Guidance more on senior mentors at work.
  arm group label: Wingman-Connect
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Peter A Wyman, PhD
  phone: 585-273-3372
  email: Peter_wyman@urmc.rochester.edu
  last name: Bryan Yates, BS
  phone: 585-276-4082
  email: bryan_yates@urmc.rochester.edu
  facility: 
  country: United States
  citation: Wyman PA, Pickering TA, Pisani AR, Cero I, Yates B, Schmeelk-Cone K, Hendricks Brown C, Gibbons RD, Simonson J, Pflanz SE. Wingman-Connect Program increases social integration for Air Force personnel at elevated suicide risk: Social network analysis of a cluster RCT. Soc Sci Med. 2022 Mar;296:114737. doi: 10.1016/j.socscimed.2022.114737. Epub 2022 Jan 22.
  PMID: 35131614
  citation: Wyman PA, Pisani AR, Brown CH, Yates B, Morgan-DeVelder L, Schmeelk-Cone K, Gibbons RD, Caine ED, Petrova M, Neal-Walden T, Linkh DJ, Matteson A, Simonson J, Pflanz SE. Effect of the Wingman-Connect Upstream Suicide Prevention Program for Air Force Personnel in Training: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2022532. doi: 10.1001/jamanetworkopen.2020.22532.
  PMID: 33084901
  responsible party type: Principal Investigator
  investigator affiliation: University of Rochester
  investigator full name: Peter Wyman
  investigator title: Professor
  mesh term: Suicide
  mesh term: Suicide Prevention
  sharing ipd: Yes
  ipd description: De-identified data on base-level suicide attempts will be made available at the NIMH Data Archive (NDA). Any coding used to manipulate data (create categories, scales) will be done in either SPSS or R and this code will also be provided via NDA or github.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: All data will be deposited to NDA starting 12 months after the award begins and will be deposited every six months thereafter following the usual NDA data submission dates.
  ipd access criteria: To request access of the data, researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable.