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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04067401
Other study ID # 1337
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 3, 2017
Est. completion date September 2, 2019

Study information

Verified date June 2020
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1485
Est. completion date September 2, 2019
Est. primary completion date September 2, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


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.
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.

Locations

Country Name City State
United States Sheppard Air Force Base Wichita Falls Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Rochester United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months
Primary 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. 1 month
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. 6 months
Secondary 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 month
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. 6 months
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 month
Secondary 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. 1 month
Secondary 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. 1 month
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