Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

SAFEGUARD Level Up Study

22 września 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

5000

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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
Brak interwencji: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
The occurrence of any harmful behavior
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Wystąpienie jakichkolwiek przedwczesnych odejść ze służby
Ramy czasowe: W ciągu 12 miesięcy po randomizacji interwencji
W ciągu 12 miesięcy po randomizacji interwencji
Słabe wyniki, wskazane przez pisemne nagany, oznaczenia w NCOER, plan działań naprawczych, szkolenie uzupełniające, działania flagowe, degradację, artykuł 15 lub zakaz ponownego zaciągu
Ramy czasowe: W ciągu 12 miesięcy po randomizacji interwencji
W ciągu 12 miesięcy po randomizacji interwencji
Personal deployment readiness
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Współpracownicy

Śledczy

  • Główny śledczy: Thomas H Nassif, PhD, Uniformed Services University of the Health Sciences

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

10 grudnia 2025

Zakończenie podstawowe (Szacowany)

1 grudnia 2027

Ukończenie studiów (Szacowany)

1 grudnia 2027

Daty rejestracji na studia

Pierwszy przesłany

3 grudnia 2025

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 grudnia 2025

Pierwszy wysłany (Rzeczywisty)

16 grudnia 2025

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

25 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • USUHS.2025-162
  • Federal Award # HU00012520025 (Inny numer grantu/finansowania: Assistant Secretary of War for Health Affairs)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .