BACKGROUND Point OutWords is a caregiver-delivered, iPad-assisted intervention for non-verbal or minimally verbal children with autism. It aims to develop prerequisite skills for communication such as manual and oral motor skills, sequencing, and symbolic representation. This feasibility trial aims to determine the viability of evaluating the clinical efficacy of Point OutWords. METHODOLOGY We aim to recruit 46 non-verbal or minimally verbal children with autism and their families, approximately 23 per arm. Children in the intervention group will use Point OutWords for half an hour, five times a week, for 8 weeks. Children in the control group will have equal caregiver-led contact time with the iPad using a selection of control apps (e.g. sensory apps, drawing apps). Communication, motor, and daily living skills are assessed at baseline and post-intervention. Parents will keep diaries during the intervention period and will take part in focus groups when the intervention is completed. DISCUSSION Point OutWords was developed in collaboration with children with autism and their caregivers, to provide an intervention for a subgroup of autism that has been historically underserved. As autism is a heterogeneous condition, it is unlikely that one style of intervention will address all aspects of its symptomatology; the motor skills approach of Point OutWords can complement other therapies that address core autistic symptoms of social cognition and communication more directly. The current feasibility trial can inform the selection of outcome measures and design for future full-scale randomised controlled trials of Point OutWords and of other early interventions in autism. TRIAL REGISTRATION ISRCTN, ISRCTN12808402. Prospectively registered on 12 March 2019.

中文翻译：

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Point OutWords：运动技能干预的可行性随机对照试验协议，以促进自闭症非语言儿童的沟通发展。


背景 Point OutWords 是一种由看护者提供、iPad 辅助的干预措施，针对非语言或很少语言的自闭症儿童。它旨在培养沟通的必备技能，例如手动和口头运动技能、排序和符号表示。该可行性试验旨在确定评估 Point OutWords 临床疗效的可行性。方法 我们的目标是招募 46 名不会说话或很少说话的自闭症儿童及其家人，每组大约 23 名。干预组的儿童将使用 Point OutWords 半小时，每周 5 次，持续 8 周。对照组的儿童将在看护者主导下使用一系列控制应用程序（例如感官应用程序、绘图应用程序）与 iPad 进行相同的接触时间。在基线和干预后评估沟通、运动和日常生活技能。家长将在干预期间记日记，并在干预完成后参加焦点小组。讨论 Point OutWords 是与自闭症儿童及其照顾者合作开发的，旨在为历史上服务不足的自闭症亚群提供干预措施。由于自闭症是一种异质性疾病，一种干预方式不太可能解决其症状的所有方面； Point OutWords 的运动技能方法可以补充其他疗法，更直接地解决社会认知和沟通的自闭症核心症状。目前的可行性试验可以为未来 Point OutWords 和其他自闭症早期干预措施的全面随机对照试验选择结果测量和设计提供信息。试用注册 ISRCTN，ISRCTN12808402。预期注册日期为 2019 年 3 月 12 日。