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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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

5000

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Texas
      • Fort Hood, Texas, Forenede Stater, 76544
        • Rekruttering
        • 3ABCT, 1st Cavalry Division
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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
Eksperimentel: 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
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The occurrence of any harmful behavior
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Forekomsten af eventuelle for tidlige afskedigelser fra tjenesten
Tidsramme: Inden for 12 måneder efter interventionens randomisering
Inden for 12 måneder efter interventionens randomisering
Dårlig præstation som angivet enten ved skriftlige reprimander, betegnelser i NCOER, en rettelsesplan, efteruddannelse, flagning, degradering, Artikel 15 eller blokeret genindtræden
Tidsramme: Inden for 12 måneder efter randomisering til intervention
Inden for 12 måneder efter randomisering til intervention
Personal deployment readiness
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Thomas H Nassif, PhD, Uniformed Services University of the Health Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. december 2025

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

3. december 2025

Først indsendt, der opfyldte QC-kriterier

3. december 2025

Først opslået (Faktiske)

16. december 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • USUHS.2025-162
  • Federal Award # HU00012520025 (Andet bevillings-/finansieringsnummer: Assistant Secretary of War for Health Affairs)

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