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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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

5000

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Texas
      • Fort Hood、Texas、美国、76544
        • 招聘中
        • 3ABCT, 1st Cavalry Division
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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:

  • 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
无干预: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The occurrence of any harmful behavior
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
任何提前终止服务的情况发生
大体时间:在干预随机化后的12个月内
在干预随机化后的12个月内
表现不佳,如书面谴责、NCOER中的标注、纠正行动计划、补救培训、标记行动、降级、第15条或禁止再次入伍所示
大体时间:在干预随机分组后的12个月内
在干预随机分组后的12个月内
Personal deployment readiness
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月10日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2025年12月3日

首先提交符合 QC 标准的

2025年12月3日

首次发布 (实际的)

2025年12月16日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月22日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • USUHS.2025-162
  • Federal Award # HU00012520025 (其他赠款/资助编号:Assistant Secretary of War for Health Affairs)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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