Career Enhancement Training Study Delivered Across Career Phases

Suicide Clinical Trial

Official title:

Career Enhancement Training Study Delivered Across Career Phases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05967364
• Other study ID #: 8549
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: August 31, 2027

Study information

• Verified date: May 2024
• Source: University of Rochester
• Contact: Peter A Wyman, PhD
• Phone: 585-273-3372
• Email: Peter_wyman[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2970
• Est. completion date: August 31, 2027
• Est. primary completion date: February 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Suicide
• Suicide Prevention

Intervention

Behavioral:
• Wingman-Connect
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.
• Stress Management
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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year