Career Enhancement Training Study Delivered Across Career Phases

Sponsor

University of Rochester (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05967364

Collaborator

(none)

2,970

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Suicide Prevention Suicide	Behavioral: Wingman-Connect Behavioral: Stress Management	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2970 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Prevention

Official Title:

Career Enhancement Training Study Delivered Across Career Phases

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Feb 28, 2027

Anticipated Study Completion Date :

Aug 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Wingman Connect 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.	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.
Active Comparator: Active Control Active control is stress management training of cognitive and behavioral strategies.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: Wingman Connect

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.

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.

Active Comparator: Active Control

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

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

At-risk cut-off of computerized adaptive testing for suicide severity [1 year]
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 [1 year]
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 [1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester	Rochester	New York	United States	14642

Sponsors and Collaborators

University of Rochester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Peter Wyman, Professor, University of Rochester

ClinicalTrials.gov Identifier:

NCT05967364

Other Study ID Numbers:

8549

First Posted:

Aug 1, 2023

Last Update Posted:

Aug 1, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peter Wyman, Professor, University of Rochester

military

suicide risk

Additional relevant MeSH terms:

Suicide

Suicide Prevention

Study Results

No Results Posted as of Aug 1, 2023