- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04067401
Career Enhancement Training Study (USAF) (CETS)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Texas
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Wichita Falls, Texas, Forenede Stater, 76311-9999
- Sheppard Air Force Base
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Aktiv komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Mean Computerized Adaptive Testing for Suicide Severity
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Mean Computerized Adaptive Testing for Depression
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Peter A Wyman, PhD, University of Rochester Medical Center, Psychiatry Dept
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1337
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Selvmordstanker
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Centre Hospitalier Universitaire de NīmesAfsluttet
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Jian-Jun OuIkke rekrutterer endnuIkke-suicidal selvskade (NSSI)Kina
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Jian-Jun OuRekrutteringIkke-suicidal selvskade (NSSI)Kina
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Xijing HospitalTilmelding efter invitationTeenager | Depression | Ikke-suicidal selvskade (NSSI)Kina
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Karolinska InstitutetAfsluttetBorderline personlighedsforstyrrelse | Ikke-suicidal selvskade (NSSI)Sverige
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Anhui Medical UniversityRekrutteringIkke-suicidal selvskadeKina
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Anhui Medical UniversityRekrutteringIkke-suicidal selvskade | DepressionslidelserKina
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Karolinska InstitutetVastra Gotaland Region; Region Skane; Region StockholmRekrutteringSelvskade | Ikke-suicidal selvskadeSverige
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Peking University Sixth HospitalIkke rekrutterer endnuKognitiv adfærdsterapi | Ikke-suicidal selvskade
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Lei HuangIkke rekrutterer endnu
Kliniske forsøg med Wingman Connect
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University of RochesterTilmelding efter invitationSelvmordsforebyggelseForenede Stater
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University of RochesterTilmelding efter invitationSelvmord | SelvmordsforebyggelseForenede Stater
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ReFlow Medical, Inc.AfsluttetKronisk total okklusion af ekstremiteternes arterieForenede Stater
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New York UniversityHofstra UniversityIkke rekrutterer endnuApraxia af tale i barndommen
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New York State Psychiatric InstituteNational Institute of Mental Health (NIMH); Columbia University; Indiana... og andre samarbejdspartnereAktiv, ikke rekrutterende
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University of ManitobaTrukket tilbageDepression | Angst | Ensomhed | Social isolationCanada
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Northwestern UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... og andre samarbejdspartnereAfsluttetDroppe ud | Fremmøde og pjækkeri | ElevengagementForenede Stater
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Massachusetts General HospitalAfsluttet
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Columbia UniversityNational Institute of Mental Health (NIMH); Chestnut Health Systems; George...RekrutteringSelvmordForenede Stater
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New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA)AfsluttetStof-relaterede lidelser | Stofbrug | Stofbrugsforstyrrelser | Stofmisbrug | Stofafhængighed | Stofrelateret problem