De Young Alexandra C, Haag Ann-Christin, Kenardy Justin A, Kimble Roy M, Landolt Markus A
Centre for Children's Burns and Trauma Research, Centre for Child Health Research, University of Queensland, Brisbane, Australia.
Department of Psychosomatics and Psychiatry and Children's Research Centre, University Children's Hospital Zurich, Zurich, Switzerland.
Trials. 2016 Jul 28;17:362. doi: 10.1186/s13063-016-1490-2.
Accidental injury represents the most common type of traumatic event experienced by children under the age of 6 years. Around 10-30 % of young injured children will go on to develop post-traumatic stress disorder (PTSD) and other co-morbid conditions. Parents of injured children are also at risk of PTSD, and this is associated with short- and long-term consequences for their children's physical and psychological recovery. Despite the significance of this problem, to date, the mental health needs of injured young children have been neglected. One reason for this is due to the uncertainty and considerable debate around how to best provide early psychological intervention to traumatised children and adults. To address these gaps, researchers and psychologists in Australia and Switzerland have developed the Coping with Accident Reactions (CARE) programme, which is a two-session early intervention designed to prevent persistent PTSD reactions in young injured children screened as 'at risk'. Two separate international studies are being conducted to evaluate the effectiveness and feasibility of this programme.
METHODS/DESIGN: The study design for the two proposed studies will employ a randomised controlled trial design and children (aged 1-6 years) who are screened as at risk for PTSD 1 week after an unintentional injury, and their parents will be randomised to either (1) CARE intervention or (2) treatment as usual. Assessment will be completed at baseline (2 weeks) and 3 and 6 months post-injury.
This international collaboration provides an excellent opportunity to test the benefit of screening and providing early intervention to young children in two different countries and settings. It is expected that outcomes from this research will lead to significant original contributions to the scientific evidence base and clinical treatment and recovery of very young injured children.
The Australian study was registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12614000325606 ) on 26 March 2014. The Swiss study was registered with ClinicalTrials.gov ( NCT02088814 ) on 12 March 2014.
意外伤害是6岁以下儿童经历的最常见创伤事件类型。约10%-30%的受伤幼儿会继而患上创伤后应激障碍（PTSD）及其他共病情况。受伤儿童的父母也有患PTSD的风险，这与孩子身体和心理恢复的短期及长期后果相关。尽管这个问题很重要，但迄今为止，受伤幼儿的心理健康需求一直被忽视。原因之一是对于如何最好地为受创伤儿童及成人提供早期心理干预存在不确定性和大量争议。为填补这些空白，澳大利亚和瑞士的研究人员及心理学家开发了应对事故反应（CARE）项目，这是一个分两阶段的早期干预项目，旨在预防被筛查为“有风险”的受伤幼儿出现持续性PTSD反应。目前正在进行两项独立的国际研究以评估该项目的有效性和可行性。
方法/设计：两项拟开展研究的研究设计将采用随机对照试验设计，在意外伤害发生1周后被筛查为有PTSD风险的1-6岁儿童及其父母将被随机分为两组：（1）CARE干预组或（2）常规治疗组。评估将在基线（2周）以及受伤后3个月和6个月时完成。
这项国际合作提供了一个绝佳机会，可在两个不同国家和环境中测试对幼儿进行筛查和提供早期干预的益处。预计该研究结果将为科学证据基础以及极年幼受伤儿童的临床治疗与康复做出重大原创贡献。
澳大利亚的研究于2014年3月26日在澳大利亚新西兰临床试验注册中心（ACTRN12614000325606）注册。瑞士的研究于2014年3月12日在美国国立医学图书馆临床试验数据库（NCT02088814）注册。
