SAFEGUARD Level Up Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniformed Services University of the Health Sciences

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Soldiers who are not present at the time of recruitment

Soldiers who are under the age of 18 years old

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

5,000 Participants
are divided into 2 treatment groups
Group A: Level Up ProgramExperimental treatment 1 intervention
Group B: Training As Usual (TAU)No intervention 0 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uniformed Services University of the Health Sciences

Lead sponsor

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