FOCUS-CI: A Preventive Intervention With Children and Families of the Combat Injured
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 6
- 主要终点
- parent and child distress (including mental health service usage, symptoms of PTSD and Depression)
研究概览
简要总结
The purpose of this study is to implement a unique evidence-based intervention program to help military families deal with the critical issue of combat injury and its impact on current and future family health and functioning. The study is a randomized study. The study will compare the effects of the newly designed FOCUS-CI (Families OverComing Under Stress - Combat Injury) with the existing standard of care (SoC) at three military medical rehabilitation sites (Walter Reed Amry Medical Center, Brooke Army Medical Center and Madigan Army Medical Center) on key aspects of family health and functioning.
详细描述
Injured service members who have at least one child between the ages of 5 and 18 years who have sustained a combat injury severe enough to require at least two weeks of inpatient hospitalization and who are within 6 months of discharge from inpatient hospitalization and currently receiving outpatient care will be recruited into this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For a family to be eligible for the study, the injured service member must:
- •have sustained a combat injury that was severe enough to require a minimum of two weeks inpatient hospitalization immediately after the injury;
- •currently be participating in outpatient rehabilitation for the same combat injury;
- •must be within 6 months of discharge from inpatient hospitalization at the start of the intervention;
- •families must have at least one child between the ages of 5 and 18 and be fluent in English. English fluency will be determined by asking, "Is English spoken in your home?"
- •pregnant women are eligible to participate.
排除标准
- •families in which the service member did not sustain a qualifying injury or has been discharged from inpatient care for more than six months will not be eligible to participate
- •families in which a member is actively psychotic
- •families in which a service member's primary relationship is with a "significant other" who is not eligible for military medical care
- •due to the limited ability of young children to comprehend the intervention activities, children under the age of 5 years will not be invited to participate in the intervention.
- •no one will be excluded based on race, ethnicity, gender, pregnancy, medical status, or cognitive functioning.
结局指标
主要结局
parent and child distress (including mental health service usage, symptoms of PTSD and Depression)
时间窗: every 12 months
次要结局
- Participant Satisfaction with Intervention(every 12 months)
- Clinician Satisfaction with Intervention(months 12 and 24 at followup)
- Child Functioning (School Functioning, and Coping) Family Functioning (Communication, Problem Solving, Roles, and Relationships)(at 12 and 24 month followup)
- Parent Functioning (including substance use, parental efficacy, parental satisfaction, parenting behavior, social support and posttraumatic growth)(at 12 and 24 month followups)