- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
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
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Level Up Study Team
- Telefonnummer: 301-660-6297
- E-mail: level-up-study-ggg@usuhs.edu
Studiesteder
-
-
Texas
-
Fort Hood, Texas, Forenede Stater, 76544
- Rekruttering
- 3ABCT, 1st Cavalry Division
-
Kontakt:
- 3ABCT Operations Officer
- Telefonnummer: 410-491-8560
- E-mail: dalton.r.coe.mil@army.mil
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
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:
|
|
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
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Thomas H Nassif, PhD, Uniformed Services University of the Health Sciences
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- USUHS.2025-162
- Federal Award # HU00012520025 (Andet bevillings-/finansieringsnummer: Assistant Secretary of War for Health Affairs)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .