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临床试验/NCT07286955
NCT07286955招募中不适用

SAFEGUARD: Life Skills Training for Soldiers Arriving at Their First Duty Location

Uniformed Services University of the Health Sciences1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2025年12月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
1
主要终点
The occurrence of any harmful behavior

研究概览

简要总结

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. Soldiers arriving at their first duty location will be randomized to receive either Level Up or a single session Army bystander intervention program. Participants will complete baseline and follow up surveys 1, 3, and 6 months post-baseline.

详细描述

Suicide remains a leading cause of death among Soldiers, especially those 17-24 years old in their first year of military service. 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 at a critical transition point in Soldiers' careers-their first duty assignment. By focusing on this particularly high-risk period, this project seeks to reduce SRBs and related harmful behaviors among U.S. Army Soldiers. 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 during a Soldier's first duty assignment.

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) a 90-minute live group session during Soldiers' in-processing week at their first duty station, 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 Engage, an existing single session Army bystander intervention program that will serve as a comparison training.

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 newly assigned junior-ranking Soldiers, a group at high risk for suicide and other serious behavioral issues. By equipping them with essential life skills and support during their first year of service, 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 Defense to inform policy, training, and future resilience-building programs-ultimately improving the health, performance, and quality of life of Soldiers across the Force.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Active 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

排除标准

  • Soldiers who are not available to attend the in-person training
  • Soldiers who are under the age of 18 years old
  • Soldiers who do not have a smart phone that supports installation of the mobile app

研究组 & 干预措施

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.

干预措施: Level Up (Behavioral)

ENGAGE Training

Active Comparator

ENGAGE is an existing single session Army bystander intervention program. The training program is based on bystander intervention and prosocial behavior research.

干预措施: ENGAGE (Behavioral)

结局指标

主要结局

The occurrence of any harmful behavior

时间窗: Within the 12 months after intervention randomization

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

The occurrence of any suicide-related behavior

时间窗: Within the 12 months after intervention randomization

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

次要结局

  • The occurrence of any premature separations from service(Within the 12 months after intervention randomization)
  • Job satisfaction(Within the 6 months after intervention randomization)
  • Incidence of traumatic brain injuries(Within the 6 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)
  • Lifetime history of various mental/emotional health problems(Within the 6 months after intervention randomization)
  • Chronic stress severity(Within the 6 months after intervention randomization)
  • Mental toughness(Within the 6 months after intervention randomization)
  • Personal deployment readiness(Within the 6 months after intervention randomization)
  • Emotionality(Within the 6 months after intervention randomization)
  • Depression symptom severity(Within the 6 months after intervention randomization)
  • Anxiety symptom severity(Within the 6 months after intervention randomization)
  • History of suicidal ideation, plan, & attempt(Within the 6 months after intervention randomization)
  • Conscientiousness(Within the 6 months after intervention randomization)
  • Mastery(Within the 6 months after intervention randomization)
  • Positive social networks(Within the 6 months after intervention randomization)
  • Negative social networks(Within the 6 months after intervention randomization)
  • Adverse childhood events & trauma(Within the 6 months after intervention randomization)
  • Mattering/belonging(Within the 6 months after intervention randomization)
  • Openness(Within the 6 months after intervention randomization)
  • Psychological well-being(Within the 6 months after intervention randomization)
  • Anger-hostility(Within the 6 months after intervention randomization)
  • Impulsivity/negative urgency(Within the 6 months after intervention randomization)
  • Loneliness(Within the 6 months after intervention randomization)
  • Problem-solving ability(Within the 6 months after intervention randomization)
  • Resilience(Within the 6 months after intervention randomization)
  • Self-esteem(Within the 6 months after intervention randomization)
  • Borderline personality(Within the 6 months after intervention randomization)
  • Anxious, Cyclothymic, Depressive, & Hyperthymic temperament(Within the 6 months after intervention randomization)
  • Introversion(Within the 6 months after intervention randomization)
  • Fearlessness about death(Within the 6 months after intervention randomization)
  • Self-conscious(Within the 6 months after intervention randomization)
  • Vulnerability(Within the 6 months after intervention randomization)
  • Frequency of risky behaviors(Within the 6 months after intervention randomization)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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