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Career Enhancement Training Study (USAF) (CETS)

Primary Purpose

Suicidal Ideation

Status
Completed
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 Suicidal Ideation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sheppard Air Force Base

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Wingman Connect

Stress Management

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Mean 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.
Mean 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.

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.
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.
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.
Mean Class Cohesion
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
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.

Full Information

First Posted
August 21, 2019
Last Updated
June 23, 2020
Sponsor
University of Rochester
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT04067401
Brief Title
Career Enhancement Training Study (USAF)
Acronym
CETS
Official Title
Career Enhancement Training Study (USAF)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 3, 2017 (Actual)
Primary Completion Date
September 2, 2019 (Actual)
Study Completion Date
September 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
United States Department of Defense

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
1485 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wingman Connect
Arm Type
Experimental
Arm Description
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).
Arm Title
Stress Management
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Wingman Connect
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stress Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean 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.
Time Frame
6 months
Title
Mean 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.
Time Frame
1 month
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
6 months
Title
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 month
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
6 months
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 month
Title
Mean Class Cohesion
Description
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.
Time Frame
1 month
Title
Mean Number of Positive Connections to Classmates
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A Wyman, PhD
Organizational Affiliation
University of Rochester Medical Center, Psychiatry Dept
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheppard Air Force Base
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76311-9999
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28493655
Citation
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.
Results Reference
background
PubMed Identifier
20634440
Citation
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.
Results Reference
background
PubMed Identifier
25692382
Citation
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.
Results Reference
background
PubMed Identifier
23117634
Citation
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.
Results Reference
background
PubMed Identifier
25068298
Citation
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.
Results Reference
background
Citation
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
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
derived

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Career Enhancement Training Study (USAF)

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