Morgan Amy J, Rapee Ronald M, Tamir Elli, Goharpey Nahal, Salim Agus, McLellan Lauren F, Bayer Jordana K
School of Psychology and Public Health, La Trobe University, Kingsbury Drive, Bundoora, Victoria, 3086, Australia.
Centre for Emotional Health, Building C3A, Level 7, Macquarie University, Sydney, NSW, 2109, Australia.
Trials. 2015 Nov 5;16:507. doi: 10.1186/s13063-015-1022-5.
Anxiety disorders are the most common type of mental health problem and begin early in life. Early intervention to prevent anxiety problems in young children who are at risk has the potential for long-term impact. The 'Cool Little Kids' parenting group program was previously established to prevent anxiety disorders in young children at risk because of inhibited temperament. This group program was efficacious in two randomised controlled trials and has recently been adapted into an online format. 'Cool Little Kids Online' was developed to widen and facilitate access to the group program's preventive content. A pilot evaluation of the online program demonstrated its perceived utility and acceptability among parents. This study aims to evaluate the efficacy of Cool Little Kids Online in a large randomised controlled trial.
METHODS/DESIGN: Parents of young children who are 3-6 years old and who have an inhibited temperament will be recruited (n = 385) and randomly assigned to either immediate access to Cool Little Kids Online or delayed access after a waiting period of 24 weeks. The online program contains eight modules that help parents address key issues in the development of anxiety problems in inhibited children, including children's avoidant coping styles, overprotective parenting behaviours, and parents' own fears and worries. Intervention participants will be offered clinician support when requested. The primary outcome will be change in parent-reported child anxiety symptoms. Secondary outcomes will be child internalising symptoms, child and family life interference due to anxiety, over-involved/protective parenting, plus child anxiety diagnoses assessed by using a new online diagnostic tool. Assessments will take place at baseline and 12 and 24 weeks after baseline.
This trial expands upon previous research on the Cool Little Kids parenting group program and will evaluate the efficacy of online delivery. Online delivery of the program could result in an easily accessible evidence-based resource to help families with young children at temperamental risk for anxiety disorders.
Australian New Zealand Clinical Trials Registry 12615000217505 (registered 5 March 2015).
焦虑症是最常见的心理健康问题类型,在儿童早期就会出现。对有风险的幼儿进行早期干预以预防焦虑问题具有长期影响的潜力。“酷小孩”育儿小组项目先前已设立,旨在预防因气质抑制而有风险的幼儿患焦虑症。该小组项目在两项随机对照试验中显示出疗效,最近已改编为在线形式。“酷小孩在线”旨在扩大并促进对该小组项目预防内容的获取。对该在线项目的初步评估表明了其在家长中的实用性和可接受性。本研究旨在在一项大型随机对照试验中评估“酷小孩在线”的疗效。
方法/设计:招募3至6岁且气质抑制的幼儿家长(n = 385),并将其随机分配为立即使用“酷小孩在线”或在24周的等待期后延迟使用。该在线项目包含八个模块,帮助家长解决气质抑制儿童焦虑问题发展中的关键问题,包括儿童的回避应对方式、过度保护的育儿行为以及家长自身的恐惧和担忧。干预参与者在需要时将获得临床医生的支持。主要结局将是家长报告的儿童焦虑症状的变化。次要结局将是儿童内化症状、焦虑对儿童和家庭生活的干扰、过度参与/保护型育儿,以及使用一种新的在线诊断工具评估的儿童焦虑诊断。评估将在基线以及基线后12周和24周进行。
本试验扩展了先前关于“酷小孩”育儿小组项目的研究,并将评估在线交付的疗效。该项目的在线交付可能会产生一个易于获取的循证资源,以帮助有气质性焦虑症风险的幼儿家庭。
澳大利亚新西兰临床试验注册中心12615000217505(2015年3月5日注册)。