- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04067401
Career Enhancement Training Study (USAF) (CETS)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Texas
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Wichita Falls, Texas, Estados Unidos, 76311-9999
- Sheppard Air Force Base
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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).
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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.
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Comparador activo: 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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mean Computerized Adaptive Testing for Suicide Severity
Periodo de tiempo: 6 months
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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.
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6 months
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Mean Computerized Adaptive Testing for Suicide Severity
Periodo de tiempo: 1 month
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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.
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1 month
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Mean Computerized Adaptive Testing for Depression
Periodo de tiempo: 6 months
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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.
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6 months
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Computerized Adaptive Testing for Depression
Periodo de tiempo: 1 month
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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.
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1 month
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Mean Behavioral Occupational Performance Outcomes
Periodo de tiempo: 6 months
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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.
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6 months
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Mean Behavioral Occupational Performance Outcomes
Periodo de tiempo: 1 month
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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.
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1 month
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Mean Class Cohesion
Periodo de tiempo: 1 month
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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.
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1 month
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Mean Number of Positive Connections to Classmates
Periodo de tiempo: 1 month
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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.
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1 month
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Peter A Wyman, PhD, University of Rochester Medical Center, Psychiatry Dept
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1337
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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