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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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

5000

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Texas
      • Fort Hood, Texas, Stati Uniti, 76544
        • Reclutamento
        • 3ABCT, 1st Cavalry Division
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The occurrence of any harmful behavior
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
L'occorrenza di qualsiasi separazione anticipata dal servizio
Lasso di tempo: Nei 12 mesi successivi alla randomizzazione dell'intervento
Nei 12 mesi successivi alla randomizzazione dell'intervento
Scarso rendimento indicato da rimproveri scritti, designazioni nel NCOER, un piano d'azione correttivo, formazione di recupero, azioni di segnalazione, retrocessione, Articolo 15 o riarruolamento impedito
Lasso di tempo: Nei 12 mesi successivi alla randomizzazione dell'intervento
Nei 12 mesi successivi alla randomizzazione dell'intervento
Personal deployment readiness
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 dicembre 2025

Completamento primario (Stimato)

1 dicembre 2027

Completamento dello studio (Stimato)

1 dicembre 2027

Date di iscrizione allo studio

Primo inviato

3 dicembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

3 dicembre 2025

Primo Inserito (Effettivo)

16 dicembre 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • USUHS.2025-162
  • Federal Award # HU00012520025 (Altro numero di sovvenzione/finanziamento: Assistant Secretary of War for Health Affairs)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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