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Career Enhancement Training Study Delivered Across Career Phases

Primary Purpose

Suicide Prevention, Suicide

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wingman-Connect
Stress Management
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 risk

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Airmen-in-Training (AiT) recruited from technical training classes that train Airmen in jobs that support the mission and aircraft of AFGSC & AMC MajComs. Eligible classes must be between 37-91 class days in length Exclusion Criteria: Airmen from other countries receiving training in US Airmen who are not in their first year of enlistment

Sites / Locations

  • University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Wingman Connect

Active Control

Arm Description

Wingman-Connect (Wyman et al., 2020 & 2022) 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.

Active control is stress management training of cognitive and behavioral strategies.

Outcomes

Primary Outcome Measures

At-risk cut-off of computerized adaptive testing for suicide severity
Participants will complete a computerized adaptive test for suicide severity. Participants will answer questions about their mental health. Participant scores will range from 0-100 with 100 indicating higher likelihood of current suicidal ideation and higher risk for suicide attempt. Scores above the published cut-off score greater than 34.

Secondary Outcome Measures

Mean computerized adaptive testing for depression
Participants will complete a computerized adaptive test for depression. Participants will answer questions about their mental health. Participant scores will range from 0-100 with 100 indicating higher risk for clinical depression.
Mean Behavioral Occupational Performance Outcomes
Participants will complete 5 yes/no questions about job performance, including if superior has expressed concerns about work performance, if Airman has received corrective training for substandard performance, received a negative counseling statement, received a Letter of Reprimand. The sum of affirmative responses will be calculated. Scores will range from 0-5 with 5 indicating greater work impairment.

Full Information

First Posted
July 21, 2023
Last Updated
July 21, 2023
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT05967364
Brief Title
Career Enhancement Training Study Delivered Across Career Phases
Official Title
Career Enhancement Training Study Delivered Across Career Phases
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (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 trial tests the effectiveness of the Wingman-Connect Program delivered by USAF personnel on individual suicide risk. Randomization will be among classes at Initial Technical Training, in which 396 classes of USAF personnel will be randomized to Wingman-Connect or to an active control training (N=2,970 Airmen) and followed for one year. These classes send a proportion of graduates to Air Force Global Strike Command (AFGSC) & Air Mobility Command (AMC) operational bases.
Detailed Description
Military suicide rates increased 61% from 2008 - 2019 and rates have increased faster in the U.S. Air Force (USAF) compared to other branches. Currently, the predominant military suicide prevention approach is to try to remediate suicide risk after suicidal individuals are identified. No RCT-validated universal programs shown to reduce vulnerability to suicide are in wide use. To fill this gap, the Wingman-Connect Program is a group-based intervention that strengthens protective relationship networks and skills for managing career and personal challenges, to reduce vulnerability to suicide across the broad USAF population. This proposed trial tests the effectiveness of the Wingman-Connect Program on individual suicide risk. We will examine theory-driven mediators and moderators and implementation of the program as delivered by US Air Force (not research) personnel under real world conditions across early career phases. This effectiveness study is the critical next stage in the translational pipeline toward large-scale roll-out to prevent suicide deaths. Classes will be randomized at Initial Technical Training (Sheppard AFB), in which 396 classes of USAF personnel will be randomized to Wingman-Connect or to an active control (N=2,970 Airmen) and followed for one year. Classes will be selected over 36 months to reach the enrollment target of 2,970. We are recruiting technical training classes that train Airmen in specific jobs that support the mission and aircraft of AFGSC & AMC MajComs. After baseline assessments (prior to randomization of classes), participants in the two conditions will complete an additional 2 assessments: 6 months and 12 months. During the follow up period, a portion of enrolled subjects will receive duty assignments at bases where the AF is implementing Wingman-Connect, providing an opportunity to learn about how varying exposure levels impacts them. Aim 1: Test effectiveness of Wingman-Connect on reducing self-reported suicide risk. We will evaluate individual level outcomes of suicide risk, depression, and occupational problems up to 1 yr. Aim 2: Evaluate theory-proposed network health mediators and moderators. Wingman-Connect is expected to increase Airmen's positive social bonds, group cohesion, morale, and healthy coping norms in their social networks; those changes will contribute to reduced suicide risk, depression and occupational problems.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Classes will be randomized at Initial Technical Training. 396 classes of USAF personnel will be randomized at a 1:2 ratio to Wingman-Connect or to an active control (N=2,970 Airmen) and followed for one year.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2970 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wingman Connect
Arm Type
Experimental
Arm Description
Wingman-Connect (Wyman et al., 2020 & 2022) 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.
Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
Active control is stress management training of cognitive and behavioral strategies.
Intervention Type
Behavioral
Intervention Name(s)
Wingman-Connect
Intervention Description
Training occurs in three 2-hr blocks over several days in class groups. 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. To extend training impact, facilitators implement activities once per quarter that bring concepts into base activities. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.
Intervention Type
Behavioral
Intervention Name(s)
Stress Management
Intervention Description
Stress management training (also done in class groups) reviews the basics of the hypothalamic-pituitary-adrenal axis stress-response system; common experiences of stress (physiological, cognitive, emotional); the impact of chronic stress on the brain and other domains of health; how exercise reduces harmful effects of stress; and relaxation techniques that have been shown to reduce stress and adverse effects of stress on health. Additional modules review the physiological stress response and effects of stress on health; introduces how cognition influences stress responses; common cognitive distortions/attributions are reviewed that affect stress including strategies to strengthen protective cognitive responses. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.
Primary Outcome Measure Information:
Title
At-risk cut-off of computerized adaptive testing for suicide severity
Description
Participants will complete a computerized adaptive test for suicide severity. Participants will answer questions about their mental health. Participant scores will range from 0-100 with 100 indicating higher likelihood of current suicidal ideation and higher risk for suicide attempt. Scores above the published cut-off score greater than 34.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Mean computerized adaptive testing for depression
Description
Participants will complete a computerized adaptive test for depression. Participants will answer questions about their mental health. Participant scores will range from 0-100 with 100 indicating higher risk for clinical depression.
Time Frame
1 year
Title
Mean Behavioral Occupational Performance Outcomes
Description
Participants will complete 5 yes/no questions about job performance, including if superior has expressed concerns about work performance, if Airman has received corrective training for substandard performance, received a negative counseling statement, received a Letter of Reprimand. The sum of affirmative responses will be calculated. Scores will range from 0-5 with 5 indicating greater work impairment.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Airmen-in-Training (AiT) recruited from technical training classes that train Airmen in jobs that support the mission and aircraft of AFGSC & AMC MajComs. Eligible classes must be between 37-91 class days in length Exclusion Criteria: Airmen from other countries receiving training in US Airmen who are not in their first year of enlistment
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
The final dataset that we will share will include self-reported demographic and behavioral data from assessments with subjects. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier for the NIMH Data Archive (NDA) will be collected for each subject. 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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Career Enhancement Training Study Delivered Across Career Phases

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