- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07286955
SAFEGUARD Level Up Study
This project will evaluate the effectiveness of Level Up: Boost Your Life Skills ("Level Up"), a strengths based, military-specific life skills training program. The goal is to determine whether Level Up can decrease suicidal-related behaviors (SRBs) and other harmful behaviors, improve mental health, enhance job performance, and reduce early military separation. The Level Up program components will be made available to participants through an online platform or mobile app that can be downloaded onto their personal mobile devices. These training materials will help Soldiers learn and practice skills. The Level Up program will also involve personalized messages from a Level Up trainer and virtual booster sessions. Active duty Soldiers who are currently stationed at Fort Hood, Texas and are members of a participating platoon will be randomized to receive either Level Up or Training as Usual (TAU). Participants will complete baseline and follow up surveys 1, 3, and 6 months post-baseline.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
The first four years of service is widely known to be an especially high-risk period for suicide-related behaviors (SRBs) among Soldiers. In addition, most suicides occur among younger Soldiers aged 17-24 years-old (40%) and 25-29 years-old (26%) compared to older Soldiers (30-34 years-old= 18%, 35+ years-old = 16%). Situational stressors are prevalent among Soldiers who die by suicide, particularly in the areas of relationship problems (42%), workplace issues (29%), and financial issues (10%). These findings align with growing literature attesting to the direct relationship between such situational stressors and later SRBs in the military This time is also marked by high rates of other harmful behaviors and of early separation from the Army. The Army invests billions of dollars in recruiting and training, yet many new Soldiers leave the service early or experience serious events like suicidal behaviors. Exposure to situational stressors involving such areas of life as romantic relationships and finances increases risk for suicide and other harmful behaviors. Implementing universal training programs to prevent these types of negative outcomes before they arise have enormous potential to bolster the mental toughness of new Soldiers during this difficult transition. The proposed project aims to prevent suicide-related behaviors (SRBs) and other behaviors qualifying for a Serious Incident Report (SIR) through an innovative, universal life skills program delivered to Soldiers at Fort Hood. The proposed project will test the effectiveness of a recently developed, evidence-based training program designed to build life skills and coping strategies that can protect against suicide, other harmful behaviors, poor work performance, and premature separation. A majority of Soldiers in a typical operational unit are of enlisted rank and 30 years of age or younger, which as discussed earlier is the demographic of highest risk for suicide. Therefore, the purpose of this study will remain focused on evaluating the effectiveness of Level Up for reducing SRBs among early career Soldiers.
This project will evaluate the effectiveness of Level Up, a strengths based, military-specific life skills training program. The goal is to determine whether Level Up can decrease suicidal thoughts and behaviors, improve mental health, enhance job performance, and reduce early military separation. Previous studies show that building skills like stress management, problem-solving, and healthy communication can protect against SRBs and related problem behaviors. However, many of these programs failed to show long-term impact, partly due to limited engagement. Level Up is designed to overcome these limitations by combining interactive learning, mobile technology, personalized coaching, and on-demand virtual booster sessions. This hybrid format is intended to help Soldiers refresh their skills and engage with content at their preferred pace and rhythm. The Level Up program components include: 1) four weekly 2-hour live group sessions, 2) a mobile app/online platform/workbook with brief, interactive self-guided exercises in core skill areas (e.g., managing stress, tactical thinking, healthy relationships), 3) personalized coaching via messages from trained staff during the first month of app use, and 4) virtual booster sessions over one year, focused on practical domains like finances, leadership, promotion tips, and personal relationships. Soldiers will be randomized to receive either Level Up or TAU.
The Level Up program content draws from evidence-based psychological methods such as Cognitive Behavioral Therapy, Acceptance and Commitment Therapy, and motivational coaching adapted to fit military culture and tailored to be relevant, accessible, and engaging for Soldiers. By equipping them with essential life skills and support, the program aims to reduce SRBs and other behaviors qualifying for SIRs, develop psychosocial skills, and increase career success and satisfaction.
If effective, Level Up could be implemented Army-wide as a universal prevention program to improve mental health, readiness, and retention. There are minimal risks as the interventions are educational, although some participants may experience brief emotional discomfort during skill practice or reflection. All participants can opt out at any time, and all are provided with resources and additional support as needed. This study could have a transformative impact on military suicide prevention efforts, especially during early service when Soldiers are most vulnerable. By evaluating this scalable program in a large, real-world setting, the research will provide clear evidence about its benefits for reducing suicide and improving readiness. Results will also support development of predictive tools to identify which Soldiers may benefit most from added support. Findings will be shared across the Department of War to inform policy, training, and future resilience-building programs-ultimately improving the health, performance, and quality of life of Soldiers across the Force.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Level Up Study Team
- Telefonszám: 301-660-6297
- E-mail: level-up-study-ggg@usuhs.edu
Tanulmányi helyek
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Texas
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Fort Hood, Texas, Egyesült Államok, 76544
- Toborzás
- 3ABCT, 1st Cavalry Division
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Kapcsolatba lépni:
- 3ABCT Operations Officer
- Telefonszám: 410-491-8560
- E-mail: dalton.r.coe.mil@army.mil
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Active duty Soldiers Active duty Soldiers who are currently stationed at Fort Hood, Texas and are members of a participating platoon.
Exclusion Criteria:
- Soldiers who are not present at the time of recruitment
- Soldiers who are under the age of 18 years old
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: Level Up Program
The Level Up program is a hybrid intervention combining interactive learning, mobile/online technology, personalized coaching, and on-demand virtual booster sessions. The evidence-based training program was designed to build life skills and coping strategies that can protect against suicide, other harmful behaviors, poor work performance, and premature separation during a Soldier's first duty assignment. |
The Level Up program components include:
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Nincs beavatkozás: Training As Usual (TAU)
TAU will serve as the study control condition. TAU will consist of other mandatory training activities determined by their unit. TAU activities include access to a variety of standard Army training resources at Fort Hood that support the mental health and well-being of Soldiers and lower risk of harmful behaviors. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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The occurrence of any harmful behavior
Időkeret: Within the 12 months after intervention randomization
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The occurrence of any harmful behavior, either self-reported in follow up surveys or administratively reported |
Within the 12 months after intervention randomization
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The occurrence of any suicide-related behavior
Időkeret: Within the 12 months after intervention randomization
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The occurrence of any suicide-related behavior, either self-reported in follow up surveys or administratively reported |
Within the 12 months after intervention randomization
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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A szolgálati idő előtti bármely megszakadásának előfordulása
Időkeret: A beavatkozás randomizálását követő 12 hónap alatt
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A beavatkozás randomizálását követő 12 hónap alatt
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Gyenge teljesítmény, amelyet írásbeli megrovások, NCOER-ben szereplő megjelölések, korrekciós intézkedési terv, pótlólagos képzés, zászlós intézkedések, lefokozás, 15. cikk vagy az újbóli toborzás tiltása jelez
Időkeret: A beavatkozás randomizálását követő 12 hónapon belül
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A beavatkozás randomizálását követő 12 hónapon belül
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Personal deployment readiness
Időkeret: Within the 6 months after intervention randomization
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Walter Reed Army Institute of Research Land Combat Survey; Scale ranges from 4-20; Higher scores indicate higher perceived readiness |
Within the 6 months after intervention randomization
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Emotionality
Időkeret: Within the 6 months after intervention randomization
|
Emotion Reactivity Scale (ERS) ; Scale ranges from0-4; Higher scores indicate higher of each maladaptive trait |
Within the 6 months after intervention randomization
|
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Job satisfaction
Időkeret: Within the 6 months after intervention randomization
|
3-item Job Satisfaction Scale; Scale ranges from 3-15; Higher scores indicate higher perceived job satisfaction |
Within the 6 months after intervention randomization
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Depression symptom severity
Időkeret: Within the 6 months after intervention randomization
|
Patient Health Questionnaire-2 (PHQ-2); Scale ranges from 0-8; Higher scores indicate more severe symptoms |
Within the 6 months after intervention randomization
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Anxiety symptom severity
Időkeret: Within the 6 months after intervention randomization
|
Generalized Anxiety Disorder-2 (GAD-2); Scale ranges from 0-8; Higher scores indicate more severe symptoms |
Within the 6 months after intervention randomization
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Incidence of traumatic brain injuries
Időkeret: Within the 6 months after intervention randomization
|
Number of traumatic brain injuries; based on the Army STARRS Surveys; No scale range; number indicates greater number of traumatic brain injuries |
Within the 6 months after intervention randomization
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Lifetime history of various mental/emotional health problems
Időkeret: Within the 6 months after intervention randomization
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Family History Screen (FHS); Scale ranges from 0-1; 0=No; 1=Yes |
Within the 6 months after intervention randomization
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Chronic stress severity
Időkeret: Within the 6 months after intervention randomization
|
Personal Life Stress Scale (PLS); Scale ranges from 0-50; Higher scores indicate greater chronic stress severity |
Within the 6 months after intervention randomization
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Mental toughness
Időkeret: Within the 6 months after intervention randomization
|
Sports Mental Toughness Questionnaire (SMTQ); Scale ranges from 5-25; Higher scores indicate higher confidence & constancy |
Within the 6 months after intervention randomization
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History of suicidal ideation, plan, & attempt
Időkeret: Within the 6 months after intervention randomization
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Columbia-Suicide Severity Rating Scale (C-SSRS) Full scale Baseline/Screening; Scale ranges from 0-1 0=No; 1=Yes |
Within the 6 months after intervention randomization
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Positive social networks
Időkeret: Within the 6 months after intervention randomization
|
Supportive & Negative Social Interaction Scale (SIS); Scale ranges from 0-8; Higher scores indicate more positive/negative social support |
Within the 6 months after intervention randomization
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Negative social networks
Időkeret: Within the 6 months after intervention randomization
|
Supportive & Negative Social Interaction Scale (SIS); Scale ranges from 0-8; Higher scores indicate more positive/negative social support |
Within the 6 months after intervention randomization
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Mattering/belonging
Időkeret: Within the 6 months after intervention randomization
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General Mattering Scale; Scale ranges from 0-20; Higher scores indicate higher perceived mattering to others |
Within the 6 months after intervention randomization
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Loneliness
Időkeret: Within the 6 months after intervention randomization
|
3-Item Loneliness Screener; Scale ranges from 0-16; Higher scores indicate more frequency-severity of loneliness |
Within the 6 months after intervention randomization
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Adverse childhood events & trauma
Időkeret: Within the 6 months after intervention randomization
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Childhood Trauma Questionnaire - Short Form (CTQ-SF) ; Scale ranges from 0-44; Higher scores indicate more childhood maltreatment |
Within the 6 months after intervention randomization
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Conscientiousness
Időkeret: Within the 6 months after intervention randomization
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Big Five Inventory (BFI)16 & Personality Inventory for DSM-5 Brief Form (PID-5-BF); Scale ranges from 0-8; Higher scores indicate lower of each adaptive trait |
Within the 6 months after intervention randomization
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Mastery
Időkeret: Within the 6 months after intervention randomization
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Pearlin & Schooler's Psychological Coping Resources Measure; Scale ranges from 0-8; Higher scores indicate lower of each adaptive trait |
Within the 6 months after intervention randomization
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Openness
Időkeret: Within the 6 months after intervention randomization
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120-item International Personality Item Pool (IPIP); Scale ranges from 0-4; Higher scores indicate lower of each adaptive trait |
Within the 6 months after intervention randomization
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Problem-solving ability
Időkeret: Within the 6 months after intervention randomization
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Social Problem Solving Inventory-Revised (SPSI-R); Scale ranges from 0-8; Higher scores indicate lower of each adaptive trait |
Within the 6 months after intervention randomization
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Psychological well-being
Időkeret: Within the 6 months after intervention randomization
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Flourishing Scale; Scale ranges from 0-12; Higher scores indicate lower of each adaptive trait |
Within the 6 months after intervention randomization
|
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Resilience
Időkeret: Within the 6 months after intervention randomization
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Army STARRS Resilience Scale; Scale ranges from 0-16; Higher scores indicate lower of each adaptive trait |
Within the 6 months after intervention randomization
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Self-esteem
Időkeret: Within the 6 months after intervention randomization
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Rosenberg Self-Esteem Scale; Scale ranges from 0-8; Higher scores indicate lower of each adaptive trait |
Within the 6 months after intervention randomization
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Anxious, Cyclothymic, Depressive, & Hyperthymic temperament
Időkeret: Within the 6 months after intervention randomization
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Revised NEO Personality Inventory (NEO-PI-R) & the Temperament Evaluation of Memphis, Pisa, Paris & San Diego-autoquestionnaire version (TEMPS-A); Scale ranges from 0-8 for each temperament; Higher scores indicate higher of each maladaptive trait |
Within the 6 months after intervention randomization
|
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Borderline personality
Időkeret: Within the 6 months after intervention randomization
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McLean Screening Instrument for Borderline Personality Disorder; Scale ranges from 0-16; Higher scores indicate higher of each maladaptive trait |
Within the 6 months after intervention randomization
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Anger-hostility
Időkeret: Within the 6 months after intervention randomization
|
Big Five Inventory (BFI)16 & Personality Inventory for DSM-5 Brief Form (PID-5-BF); Scale ranges from 0-8; Higher scores indicate higher of each maladaptive trait |
Within the 6 months after intervention randomization
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Impulsivity/negative urgency
Időkeret: Within the 6 months after intervention randomization
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Impulsive Behavior Scale - Short Form (SUPPS-P); Scale ranges from 0-8; Higher scores indicate higher of each maladaptive trait |
Within the 6 months after intervention randomization
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Introversion
Időkeret: Within the 6 months after intervention randomization
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Eysenck Personality Questionnaire - Brief Version (EPQ-BV)28 & Revised NEO Personality Inventory (NEO-PI-R); Scale ranges from 0-8; Higher scores indicate higher of each maladaptive trait |
Within the 6 months after intervention randomization
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Fearlessness about death
Időkeret: Within the 6 months after intervention randomization
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Acquired Capability for Suicide Scale; Scale ranges from 0-4; Higher scores indicate higher of each maladaptive trait |
Within the 6 months after intervention randomization
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Self-conscious
Időkeret: Within the 6 months after intervention randomization
|
Widiger Five-Factor Rating Form - Revised31 & NEO Five-Factor Inventory (NEO-FFI); Scale ranges from 0-8; Higher scores indicate higher of each maladaptive trait |
Within the 6 months after intervention randomization
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Vulnerability
Időkeret: Within the 6 months after intervention randomization
|
NEO Five-Factor Inventory (NEO-FFI); Scale ranges from 0-4; Higher scores indicate higher of each maladaptive trait |
Within the 6 months after intervention randomization
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Frequency of risky behaviors
Időkeret: Within the 6 months after intervention randomization
|
Unit Risk Inventory (URI); Scale ranges from 0-1; 0=Never; 1=At least less than once a month |
Within the 6 months after intervention randomization
|
Együttműködők és nyomozók
Együttműködők
Nyomozók
- Kutatásvezető: Thomas H Nassif, PhD, Uniformed Services University of the Health Sciences
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- USUHS.2025-162
- Federal Award # HU00012520025 (Egyéb támogatási/finanszírozási szám: Assistant Secretary of War for Health Affairs)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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