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SAFEGUARD Level Up Study

2026. szeptember 22. frissítette: Uniformed Services University of the Health Sciences

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

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

Beavatkozó

Beiratkozás (Becsült)

5000

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Igen

Tanulmányozható nemek

Összes

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

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

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
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:

  • Four weekly 2-hour live group sessions
  • A mobile app/online platform/workbook with brief, interactive self-guided exercises in core skill areas (e.g., managing stress, tactical thinking, healthy relationships)
  • Personalized coaching via messages from trained Level Up staff during the first month of app use
  • Virtual booster sessions over one year, focused on practical domains like finances, leadership, promotion tips, and personal relationships
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
The occurrence of any harmful behavior
Időkeret: Within the 12 months after intervention randomization

The occurrence of any harmful behavior, either self-reported in follow up surveys or administratively reported

Within the 12 months after intervention randomization
The occurrence of any suicide-related behavior
Időkeret: Within the 12 months after intervention randomization

The occurrence of any suicide-related behavior, either self-reported in follow up surveys or administratively reported

Within the 12 months after intervention randomization

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
A szolgálati idő előtti bármely megszakadásának előfordulása
Időkeret: A beavatkozás randomizálását követő 12 hónap alatt
A beavatkozás randomizálását követő 12 hónap alatt
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
A beavatkozás randomizálását követő 12 hónapon belül
Personal deployment readiness
Időkeret: Within the 6 months after intervention randomization

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
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
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
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
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
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
Lifetime history of various mental/emotional health problems
Időkeret: Within the 6 months after intervention randomization

Family History Screen (FHS); Scale ranges from 0-1; 0=No; 1=Yes

Within the 6 months after intervention randomization
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
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
History of suicidal ideation, plan, & attempt
Időkeret: Within the 6 months after intervention randomization

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
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
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
Mattering/belonging
Időkeret: Within the 6 months after intervention randomization

General Mattering Scale; Scale ranges from 0-20; Higher scores indicate higher perceived mattering to others

Within the 6 months after intervention randomization
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
Adverse childhood events & trauma
Időkeret: Within the 6 months after intervention randomization

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
Conscientiousness
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 lower of each adaptive trait

Within the 6 months after intervention randomization
Mastery
Időkeret: Within the 6 months after intervention randomization

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
Openness
Időkeret: Within the 6 months after intervention randomization

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
Problem-solving ability
Időkeret: Within the 6 months after intervention randomization

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
Psychological well-being
Időkeret: Within the 6 months after intervention randomization

Flourishing Scale; Scale ranges from 0-12; Higher scores indicate lower of each adaptive trait

Within the 6 months after intervention randomization
Resilience
Időkeret: Within the 6 months after intervention randomization

Army STARRS Resilience Scale; Scale ranges from 0-16; Higher scores indicate lower of each adaptive trait

Within the 6 months after intervention randomization
Self-esteem
Időkeret: Within the 6 months after intervention randomization

Rosenberg Self-Esteem Scale; Scale ranges from 0-8; Higher scores indicate lower of each adaptive trait

Within the 6 months after intervention randomization
Anxious, Cyclothymic, Depressive, & Hyperthymic temperament
Időkeret: Within the 6 months after intervention randomization

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
Borderline personality
Időkeret: Within the 6 months after intervention randomization

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
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
Impulsivity/negative urgency
Időkeret: Within the 6 months after intervention randomization

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
Introversion
Időkeret: Within the 6 months after intervention randomization

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
Fearlessness about death
Időkeret: Within the 6 months after intervention randomization

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
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
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
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

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2025. december 10.

Elsődleges befejezés (Becsült)

2027. december 1.

A tanulmány befejezése (Becsült)

2027. december 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2025. december 3.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2025. december 3.

Első közzététel (Tényleges)

2025. december 16.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. szeptember 25.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. szeptember 22.

Utolsó ellenőrzés

2026. szeptember 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

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)?

NEM

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

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