ClinicalTrials.gg
RecruitingNCT07286955Updated Sep 25, 2026

SAFEGUARD Level Up Study

An interventional study of Level Up in Risk Reduction Behavior, Suicide Prevention and Risky Behavior, sponsored by Uniformed Services University of the Health Sciences. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Uniformed Services University of the Health Sciences · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Dec 2025; still recruiting 11 months later.
Updated Sep 25, 2026Primary completion movedStudy completion moved+6 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
5,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Risk Reduction Behavior
  • Suicide Prevention
  • Risky Behavior
  • Mental Health
  • Resilience
  • Performance at Work

Keywords

  • Military Health
  • Suicide Prevention
  • Harmful Behaviors
  • Life Skills Training
  • First Duty Location
  • Active-duty Military
  • Risk Reduction
  • Prevention
  • Level Up
03

In context

Risk Reduction Behavior

291 studies on the registry are indexed under Risk Reduction Behavior; 39 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 201 across 250 interventional studies indexed under Risk Reduction Behavior.

Browse Risk Reduction Behavior studies →

Lead sponsor

Uniformed Services University of the Health Sciences is the lead sponsor of 45 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Sep 25, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Soldiers who are not present at the time of recruitment
  • Soldiers who are under the age of 18 years old
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5,000 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Level Up

  • No intervention
    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.

Interventions

  • BehavioralLevel Up

    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

06

What researchers measure

Primary outcomes

  1. The occurrence of any harmful behavior

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

    Time frame: Within the 12 months after intervention randomization

  2. The occurrence of any suicide-related behavior

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

    Time frame: Within the 12 months after intervention randomization

Secondary outcomes

  1. The occurrence of any premature separations from service

    Time frame: Within the 12 months after intervention randomization

  2. Poor performance as indicated either by written reprimands, designations in the NCOER, a corrective action plan, remedial training, flagging actions, demotion, Article 15, or barred reenlistment

    Time frame: Within the 12 months after intervention randomization

  3. Personal deployment readiness

    Walter Reed Army Institute of Research Land Combat Survey; Scale ranges from 4-20; Higher scores indicate higher perceived readiness

    Time frame: Within the 6 months after intervention randomization

  4. Emotionality

    Emotion Reactivity Scale (ERS) ; Scale ranges from0-4; Higher scores indicate higher of each maladaptive trait

    Time frame: Within the 6 months after intervention randomization

  5. Job satisfaction

    3-item Job Satisfaction Scale; Scale ranges from 3-15; Higher scores indicate higher perceived job satisfaction

    Time frame: Within the 6 months after intervention randomization

  6. Depression symptom severity

    Patient Health Questionnaire-2 (PHQ-2); Scale ranges from 0-8; Higher scores indicate more severe symptoms

    Time frame: Within the 6 months after intervention randomization

  7. Anxiety symptom severity

    Generalized Anxiety Disorder-2 (GAD-2); Scale ranges from 0-8; Higher scores indicate more severe symptoms

    Time frame: Within the 6 months after intervention randomization

  8. Incidence of traumatic brain injuries

    Number of traumatic brain injuries; based on the Army STARRS Surveys; No scale range; number indicates greater number of traumatic brain injuries

    Time frame: Within the 6 months after intervention randomization

  9. Lifetime history of various mental/emotional health problems

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

    Time frame: Within the 6 months after intervention randomization

  10. Chronic stress severity

    Personal Life Stress Scale (PLS); Scale ranges from 0-50; Higher scores indicate greater chronic stress severity

    Time frame: Within the 6 months after intervention randomization

  11. Mental toughness

    Sports Mental Toughness Questionnaire (SMTQ); Scale ranges from 5-25; Higher scores indicate higher confidence \& constancy

    Time frame: Within the 6 months after intervention randomization

  12. History of suicidal ideation, plan, & attempt

    Columbia-Suicide Severity Rating Scale (C-SSRS) Full scale Baseline/Screening; Scale ranges from 0-1 0=No; 1=Yes

    Time frame: Within the 6 months after intervention randomization

  13. Positive social networks

    Supportive \& Negative Social Interaction Scale (SIS); Scale ranges from 0-8; Higher scores indicate more positive/negative social support

    Time frame: Within the 6 months after intervention randomization

  14. Negative social networks

    Supportive \& Negative Social Interaction Scale (SIS); Scale ranges from 0-8; Higher scores indicate more positive/negative social support

    Time frame: Within the 6 months after intervention randomization

  15. Mattering/belonging

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

    Time frame: Within the 6 months after intervention randomization

  16. Loneliness

    3-Item Loneliness Screener; Scale ranges from 0-16; Higher scores indicate more frequency-severity of loneliness

    Time frame: Within the 6 months after intervention randomization

  17. Adverse childhood events & trauma

    Childhood Trauma Questionnaire - Short Form (CTQ-SF) ; Scale ranges from 0-44; Higher scores indicate more childhood maltreatment

    Time frame: Within the 6 months after intervention randomization

  18. Conscientiousness

    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

    Time frame: Within the 6 months after intervention randomization

  19. Mastery

    Pearlin \& Schooler's Psychological Coping Resources Measure; Scale ranges from 0-8; Higher scores indicate lower of each adaptive trait

    Time frame: Within the 6 months after intervention randomization

  20. Openness

    120-item International Personality Item Pool (IPIP); Scale ranges from 0-4; Higher scores indicate lower of each adaptive trait

    Time frame: Within the 6 months after intervention randomization

  21. Problem-solving ability

    Social Problem Solving Inventory-Revised (SPSI-R); Scale ranges from 0-8; Higher scores indicate lower of each adaptive trait

    Time frame: Within the 6 months after intervention randomization

  22. Psychological well-being

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

    Time frame: Within the 6 months after intervention randomization

  23. Resilience

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

    Time frame: Within the 6 months after intervention randomization

  24. Self-esteem

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

    Time frame: Within the 6 months after intervention randomization

  25. Anxious, Cyclothymic, Depressive, & Hyperthymic temperament

    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

    Time frame: Within the 6 months after intervention randomization

  26. Borderline personality

    McLean Screening Instrument for Borderline Personality Disorder; Scale ranges from 0-16; Higher scores indicate higher of each maladaptive trait

    Time frame: Within the 6 months after intervention randomization

  27. Anger-hostility

    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

    Time frame: Within the 6 months after intervention randomization

  28. Impulsivity/negative urgency

    Impulsive Behavior Scale - Short Form (SUPPS-P); Scale ranges from 0-8; Higher scores indicate higher of each maladaptive trait

    Time frame: Within the 6 months after intervention randomization

  29. Introversion

    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

    Time frame: Within the 6 months after intervention randomization

  30. Fearlessness about death

    Acquired Capability for Suicide Scale; Scale ranges from 0-4; Higher scores indicate higher of each maladaptive trait

    Time frame: Within the 6 months after intervention randomization

  31. Self-conscious

    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

    Time frame: Within the 6 months after intervention randomization

  32. Vulnerability

    NEO Five-Factor Inventory (NEO-FFI); Scale ranges from 0-4; Higher scores indicate higher of each maladaptive trait

    Time frame: Within the 6 months after intervention randomization

  33. Frequency of risky behaviors

    Unit Risk Inventory (URI); Scale ranges from 0-1; 0=Never; 1=At least less than once a month

    Time frame: Within the 6 months after intervention randomization

07

Study locations

1 of 1 sites recruiting
  • 3ABCT, 1st Cavalry Division
    Fort Hood, Texas 76544, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Dec 2027, 24 months after the start.

Of 167 non-industry interventional studies with no phase under Risk Reduction Behavior, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 42. This study's planned 24 months is close to that.

Counting every sponsor, half of 169 studies reached it within 25 months; a quarter within 13 and three quarters within 46.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 25, 2026: primary completion Jul 2028 → Dec 2027 and completion Jul 2029 → Dec 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 3, 2025
First posted
Dec 16, 2025
StartActual
Dec 10, 2025
Primary completionEst.
Dec 2027was Jul 2028
CompletionEst.
Dec 2027was Jul 2029
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added, 1 site removed
Show site
  • 3ABCT, 1st Cavalry Division · Fort Hood, United States
Show 1 removed
  • Fort Hood Installation Reception Center · Fort Hood, United States
Sep 25, 2026
Primary completion
Jul 1, 2028→Dec 2027
Sep 25, 2026
Study completion
Jul 1, 2029→Dec 2027
Sep 25, 2026
Eligibility
1 inclusion criterion added, 1 removed; 1 exclusion criterion added, 2 removed
What changed in the criteria
Inclusion criteria
  • RemovedActive duty Soldiers arriving at a military installation located in the South Central U.S. for their first duty location who are attending reception center activities
  • AddedActive duty Soldiers Active duty Soldiers who are currently stationed at Fort Hood, Texas and are members of a participating platoon.
Exclusion criteria
  • RemovedSoldiers who are not available to attend the in-person training
  • AddedSoldiers who are not present at the time of recruitment
  • RemovedSoldiers who do not have a smart phone that supports installation of the mobile app
Sep 25, 2026
Interventions
Removed Behavioral: ENGAGE. Arms added: Training As Usual (TAU); arms removed: ENGAGE Training
Sep 25, 2026
Contact
Study contact changed: l•••@usuhs.edu · •••9711→l•••@usuhs.edu · •••6297. See the current contact
Sep 25, 2026
Title
Life Skills Training for Soldiers Arriving at Their First Duty Location→SAFEGUARD Level Up Study
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    1 site added, 1 site removed
    Show site
    • 3ABCT, 1st Cavalry Division · Fort Hood, United States
    Show 1 removed
    • Fort Hood Installation Reception Center · Fort Hood, United States
    Primary completion Jul 1, 2028→Dec 2027
    Study completion Jul 1, 2029→Dec 2027
    Eligibility 1 inclusion criterion added, 1 removed; 1 exclusion criterion added, 2 removed
    What changed in the criteria
    Inclusion criteria
    • RemovedActive duty Soldiers arriving at a military installation located in the South Central U.S. for their first duty location who are attending reception center activities
    • AddedActive duty Soldiers Active duty Soldiers who are currently stationed at Fort Hood, Texas and are members of a participating platoon.
    Exclusion criteria
    • RemovedSoldiers who are not available to attend the in-person training
    • AddedSoldiers who are not present at the time of recruitment
    • RemovedSoldiers who do not have a smart phone that supports installation of the mobile app
    Interventions Removed Behavioral: ENGAGE. Arms added: Training As Usual (TAU); arms removed: ENGAGE Training
    Contact Study contact changed: l•••@usuhs.edu · •••9711→l•••@usuhs.edu · •••6297. See the current contact
    Title Life Skills Training for Soldiers Arriving at Their First Duty Location→SAFEGUARD Level Up Study
    + 3 other changes: index terms, verification date and description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07286955
Lead sponsor
Uniformed Services University of the Health Sciences
Collaborators
Defense Health Agency, Harvard University, Henry M. Jackson Foundation for the Advancement of Military Medicine, Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Walter Reed Army Institute of Research (WRAIR), University of Michigan
Responsible party
Sponsor
First posted
Dec 16, 2025
Start date
Dec 10, 2025
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Level Up Study Team
Contact
level-up-study-ggg@usuhs.edu
301-660-6297
Thomas H Nassif, PhD
principal investigator · Uniformed Services University of the Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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