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Career Enhancement Training Study (USAF) (CETS)

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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:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Peter Wyman, University of Rochester

Tracking Information
First Submitted Date  ICMJE August 21, 2019
First Posted Date  ICMJE August 26, 2019
Results First Submitted Date  ICMJE June 2, 2020
Results First Posted Date  ICMJE July 8, 2020
Last Update Posted Date July 8, 2020
Actual Study Start Date  ICMJE October 3, 2017
Actual Primary Completion Date September 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Career Enhancement Training Study (USAF)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE Suicidal Ideation
Intervention  ICMJE
  • 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2019)
1485
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2, 2019
Actual Primary Completion Date September 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04067401
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Peter Wyman, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: Peter A Wyman, PhD University of Rochester Medical Center, Psychiatry Dept
PRS Account University of Rochester
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP