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Population Impact of Wingman-Connect Implemented by the US Air Force

Primary Purpose

Suicide Prevention

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wingman-Connect
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide Prevention focused on measuring military, suicide rates

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Data from bases in the Air Force Global Strike Command (AFGSC) & Air Mobility Command (AMC) MajComs. 96 implementers (4-5 per base over at each data point, and 8-12 respondents per site across the study period) Exclusion Criteria: none

Sites / Locations

  • University of Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Wingman-Connect

Arm 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.

Outcomes

Primary Outcome Measures

Total Number Base level suicide attempts among Ranks E1-4
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).

Secondary Outcome Measures

Full Information

First Posted
July 25, 2023
Last Updated
October 17, 2023
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT05973942
Brief Title
Population Impact of Wingman-Connect Implemented by the US Air Force
Official Title
Population Impact of Wingman-Connect Implemented by the US Air Force
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2024 (Anticipated)
Primary Completion Date
February 28, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
The US Air Force is putting into regular practice the Wingman-Connect Program 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide Prevention
Keywords
military, suicide rates

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
17400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wingman-Connect
Arm Type
Experimental
Arm 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(s)
Wingman-Connect
Intervention 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.
Primary Outcome Measure Information:
Title
Total Number Base level suicide attempts among Ranks E1-4
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).
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Data from bases in the Air Force Global Strike Command (AFGSC) & Air Mobility Command (AMC) MajComs. 96 implementers (4-5 per base over at each data point, and 8-12 respondents per site across the study period) Exclusion Criteria: none
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter A Wyman, PhD
Phone
585-273-3372
Email
Peter_wyman@urmc.rochester.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Bryan Yates, BS
Phone
585-276-4082
Email
bryan_yates@urmc.rochester.edu
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan 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 Sharing 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 Sharing 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.
Citations:
PubMed Identifier
35131614
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.
Results Reference
background
PubMed Identifier
33084901
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.
Results Reference
background

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Population Impact of Wingman-Connect Implemented by the US Air Force

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