SAFEGUARD Level Up Study

NCT07286955 | Recruiting DMC

• 2 other identifiers: USUHS.2025-162Federal Award # HU00012520025
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• The occurrence of any harmful behavior

  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

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

  Within the 12 months after intervention randomization

Secondary Outcomes (33)

• The occurrence of any premature separations from service

  Within the 12 months after intervention randomization

• 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

  Within the 12 months after intervention randomization

• Personal deployment readiness

  Within the 6 months after intervention randomization

• Emotionality

  Within the 6 months after intervention randomization

• Job satisfaction

  Within the 6 months after intervention randomization

Study Arms (2)

Level Up Program

EXPERIMENTAL

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

Training As Usual (TAU)

NO INTERVENTION

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

Level Up BEHAVIORAL

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

Level Up Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead
• Defense Health Agency: collaborator
• Harvard University: collaborator
• Henry M. Jackson Foundation for the Advancement of Military Medicine: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Massachusetts General Hospital: collaborator
• Walter Reed Army Institute of Research (WRAIR): collaborator
• University of Michigan: collaborator

Study Sites (1)

3ABCT, 1st Cavalry Division

Fort Hood, Texas, 76544, United States

RECRUITING

MeSH Terms

Conditions

Risk Reduction Behavior; Suicide Prevention; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavior; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Personal Satisfaction

Study Officials

• Thomas H Nassif, PhD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Level Up Study Team

CONTACT

301-660-6297; level-up-study-ggg@usuhs.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)