Career Enhancement Training Study (USAF) (CETS)

• ClinicalTrials.gov Identifier: NCT04067401
• Recruitment Status: Completed
• First Posted: August 26, 2019
• Results First Posted: July 8, 2020
• Last Update Posted: July 8, 2020
• Sponsor: University of Rochester
• Collaborator: United States Department of Defense
• Information provided by (Responsible Party): Peter Wyman, University of Rochester

Tracking Information

• First Submitted Date: August 21, 2019
• First Posted Date: August 26, 2019
• Results First Submitted Date: June 2, 2020
• Results First Posted Date: July 8, 2020
• Last Update Posted Date: July 8, 2020
• Actual Study Start Date: October 3, 2017
• Actual Primary Completion Date: September 2, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 23, 2020)

• Mean Computerized Adaptive Testing for Suicide Severity [ Time Frame: 6 months ]
  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.
• Mean Computerized Adaptive Testing for Suicide Severity [ Time Frame: 1 month ]
  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.

Original Primary Outcome Measures (submitted: August 21, 2019)

Mean Computerized Adaptive Testing for Suicide Severity [ Time Frame: 6 months ]

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.

Current Secondary Outcome Measures (submitted: June 23, 2020)

• Mean Computerized Adaptive Testing for Depression [ Time Frame: 6 months ]
  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.
• Computerized Adaptive Testing for Depression [ Time Frame: 1 month ]
  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 [ Time Frame: 6 months ]
  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.
• Mean Behavioral Occupational Performance Outcomes [ Time Frame: 1 month ]
  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.
• Mean Class Cohesion [ Time Frame: 1 month ]
  Participants will complete a 3-item scale on how well members of their class cooperate, can depend on each other and stand up for each other. Scores range from 0 to 4 with higher scores indicating higher class cohesion.
• Mean Number of Positive Connections to Classmates [ Time Frame: 1 month ]
  Participants will be asked to name up to 5 other students in their class who they respect and would choose to spend time with. Participants can name 0-5 classmates.

Original Secondary Outcome Measures (submitted: August 21, 2019)

• Mean Computerized Adaptive Testing for Depression [ Time Frame: 6 months ]
  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 Class Cohesion [ Time Frame: 1 month ]
  Participants will complete a 3-item scale on how well members of their class cooperate, can depend on each other and stand up for each other. Scores range from 0 to 4 with higher scores indicating higher class cohesion.
• Mean Number of Positive Connections to Classmates [ Time Frame: 1 month ]
  Participants will be asked to name up to 5 other students in their class who they respect and would choose to spend time with. Participants can name 0-5 classmates.
• Mean Behavioral Occupational Performance Outcomes [ Time Frame: 6 months ]
  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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Career Enhancement Training Study (USAF)
• Official Title: Career Enhancement Training Study (USAF)
• Brief Summary: A study evaluating a training program to decrease risk for suicidal thoughts and behaviors among early career trainees in the United States Air Force.

Detailed Description

Relationship disruptions and social isolation are major precipitants for military suicides and a range of problems that impair functioning and reduce mission readiness. However, nearly all current military suicide prevention programming focuses on a narrow range of approaches for individuals already at high-risk (e.g., training to detect warning signs and refer for treatment services). This project addresses the need for universal prevention approaches to proactively strengthen protective factors across military populations, including strengthening social connectedness and skills to grow and sustain relationships across service.

The aims of this project are to (a) develop an intervention for early-career, enlisted United States Air Force personnel using an active training approach to strengthening social bonds, and (b) test the intervention (i.e., Wingman-Connect) using a randomized controlled trial design.

Wingman-Connect focuses on Airman-in-Training to build protective factors in: Kinship (healthy bonds); Guidance (support from mentors and mental health); Purpose (goals, sense of being valued and valuable); and Balance (self-care and support). Half of the training is focused on the class as a group to build belonging and shared purpose.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The study design will involve randomizing approximately 1440 Airman-in-Training (AiT) within 160 Technical Training classes to one of two conditions: Wingman-Connect or a brief Stress Management training. Randomization will occur at the class level, since Wingman-Connect is designed to train AiTs within a class together as a group (those who voluntarily enroll).

Masking: None (Open Label)
Primary Purpose: Prevention

• Condition: Suicidal Ideation

Intervention

• Behavioral: Wingman Connect
  Wingman-Connect combines group and individual skill training. Group exercises build cohesion, belonging and shared purpose, and promote value of healthy unit, giving and receiving support. Individual skills promote the ability to thrive during transitions, manage stressors and meet career goals, and decrease barriers to utilizing organizational resources (family, health). The training has a total of 22 modules comprised of specific learning objectives and activities. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.
• Behavioral: Stress Management
  Stress management training 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.

Study Arms

• Experimental: Wingman Connect
  Wingman-Connect total training time is 5 hours, typically spread over three consecutive training 'blocks'(or days), plus 1-hour of booster training (one month later).
  Intervention: Behavioral: Wingman Connect
• Active Comparator: Stress Management
  The control training condition will consist of a 2 hr. informational training that provides an overview of the human stress response system and strategies to manage stress. The training will be delivered through lecture format using PowerPoint, supplemented by brief videos and interactive discussion.
  Intervention: Behavioral: Stress Management

Publications *

• Gibbons RD, Kupfer D, Frank E, Moore T, Beiser DG, Boudreaux ED. Development of a Computerized Adaptive Test Suicide Scale-The CAT-SS. J Clin Psychiatry. 2017 Nov/Dec;78(9):1376-1382. doi: 10.4088/JCP.16m10922.
• Wyman PA, Brown CH, LoMurray M, Schmeelk-Cone K, Petrova M, Yu Q, Walsh E, Tu X, Wang W. An outcome evaluation of the Sources of Strength suicide prevention program delivered by adolescent peer leaders in high schools. Am J Public Health. 2010 Sep;100(9):1653-61. doi: 10.2105/AJPH.2009.190025. Epub 2010 Jul 15.
• Petrova M, Wyman PA, Schmeelk-Cone K, Pisani AR. Positive-Themed Suicide Prevention Messages Delivered by Adolescent Peer Leaders: Proximal Impact on Classmates' Coping Attitudes and Perceptions of Adult Support. Suicide Life Threat Behav. 2015 Dec;45(6):651-63. doi: 10.1111/sltb.12156. Epub 2015 Feb 18.
• Gibbons RD, Weiss DJ, Pilkonis PA, Frank E, Moore T, Kim JB, Kupfer DJ. Development of a computerized adaptive test for depression. Arch Gen Psychiatry. 2012 Nov;69(11):1104-12. doi: 10.1001/archgenpsychiatry.2012.14. Erratum in: Arch Gen Psychiatry. 2013 Jan;70(1):30.
• Herrell RK, Edens EN, Riviere LA, Thomas JL, Bliese PD, Hoge CW. Assessing functional impairment in a working military population: the Walter Reed functional impairment scale. Psychol Serv. 2014 Aug;11(3):254-64. doi: 10.1037/a0037347.
• Williams, J, Brown, JM, Bray, RM, Anderson Goodell, EM, Olmsted, KR, Adler, AB. (2016) Unit Cohesion, Resilience, and Mental Health of Soldiers in Basic Combat Training, Military Psychology, 28:4, 241-250, DOI: 10.1037/mil0000120
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 21, 2019): 1485
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 2, 2019
• Actual Primary Completion Date: September 2, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Airmen-in-Training (AiT) in Technical Training classes in the 365 or 363 Training Squadrons of the 82 Training Wing (82 TRW)
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04067401
• Other Study ID Numbers: 1337
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Peter Wyman, University of Rochester
• Study Sponsor: University of Rochester
• Collaborators: United States Department of Defense

Investigators

• Principal Investigator: Peter A Wyman, PhD; University of Rochester Medical Center, Psychiatry Dept

• PRS Account: University of Rochester
• Verification Date: June 2020