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Risk Reduction BehaviorNCT07286955

SAFEGUARD Level Up Study

A study testing Level Up in people with Risk Reduction Behavior and Suicide Prevention, run by Uniformed Services University of the Health Sciences at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Level Up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,000 participants
Where
1 siteUnited States
Study dates
10 Dec 2025to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Active duty Soldiers Active duty Soldiers who are currently stationed at Fort Hood, Texas and are members of a participating platoon.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Level Up Study Team contact

301-660-6297

level-up-study-ggg@usuhs.edu

United States1 site, 1 recruiting
  • 3ABCT, 1st Cavalry Division

    Fort Hood, Texas, 76544

    3ABCT Operations Officer, 410-491-8560, dalton.r.coe.mil@army.mil

    Recruiting

Other trials in United States

About this 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.

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.

Being tested
Level Up
Keywords
Military Health, Suicide Prevention, Harmful Behaviors, Life Skills Training, First Duty Location, Active-duty Military, Risk Reduction, Prevention, Level Up
Medical subject headings
Risk Reduction Behavior, Suicide Prevention, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Level UpBehavioural

    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
Study groups in NCT07286955
Study groupRoleWhat they receive
Level Up ProgramExperimentalThe 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.
Receives: Behavioral: Level Up
Training As Usual (TAU)No interventionTAU 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The occurrence of any harmful behavior

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

    Measured: 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

    Measured: Within the 12 months after intervention randomization

Secondary outcomes (33)
  1. The occurrence of any premature separations from service

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Within the 6 months after intervention randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2025
  2. Study start10 Dec 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07286955
Sponsor's protocol ID
USUHS.2025-162
Other IDs
Federal Award # HU00012520025
Status last verified
Sep 2026
First submitted
3 Dec 2025
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Level Up in people with Risk Reduction Behavior and Suicide Prevention, run by Uniformed Services University of the Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Level Up Study Team (301-660-6297, level-up-study-ggg@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The occurrence of any harmful behavior (time frame: Within the 12 months after intervention randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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