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Point OutWords: protocol for a feasibility randomised controlled trial of a motor skills intervention to promote communicative development in non-verbal children with autism.
Trials ( IF 2.5 ) Pub Date : 2020-01-23 , DOI: 10.1186/s13063-019-3931-1
Ailbhe McKinney 1 , Kathryn L Hotson 1 , Alicia Rybicki 2 , Emma J L Weisblatt 3, 4 , Claudia Días 4 , Juliet Foster 5 , Sofía S Villar 6 , Suzanne Murphy 7 , Matthew K Belmonte 1, 8
Affiliation  

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:

Point OutWords:一项运动技能干预措施的可行性随机对照试验协议,旨在促进非语言自闭症儿童的交流发展。

背景技术Point OutWords是由护理人员提供的,iPad辅助的自闭症非言语或非言语儿童的干预措施。它旨在发展沟通的先决条件,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名非语言或最少言语自闭症儿童及其家人,每只手臂大约23名。干预组的孩子每周半五次使用Point OutWords,持续8周。对照组中的儿童将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的照料者主导的接触时间相等。通讯,电机 在基线和干预后评估日常生活技能。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,旨在为自闭症亚组提供干预措施,而亚组自古以来就没有得到足够的服务。由于自闭症是一种异质性疾病,因此一种干预方式不可能解决其症状学的所有方面。Point OutWords的运动技能方法可以补充其他疗法,从而更直接地解决社交认知和沟通的核心自闭症症状。当前的可行性试验可以为Point OutWords以及其他自闭症早期干预措施的未来全规模随机对照试验的结局指标和设计选择提供依据。试用注册号ISRCTN,ISRCTN12808402。预期于2019年3月12日注册。
更新日期:2020-01-23
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