Pilot study protocol evaluating the impact of telerobotics interactions with autistic children during a Denver intervention on communication skills using single-case experimental design.

IF 2.4 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL BMJ Open Pub Date : 2024-11-12 DOI:10.1136/bmjopen-2024-084110
Carole Fournier, Cécile Michelon, Véronique Granit, Paul Audoyer, Arielle Bernardot, Marie-Christine Picot, Abderrahmane Kheddar, Amaria Baghdadli
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Abstract

Introduction: For several years, studies have been conducted on the contribution of social robots as an intervention tool for children with autism spectrum disorder (ASD). One of the early intervention models recommended by the French National Authority for Health is the Early Start Denver Model, an individualised, intensive programme based on play activities chosen by the child. While studies published in recent years suggest that robots provide benefits for autistic children in learning social interactions within a clinical setting, there is no scientific consensus on the widespread contribution and maintenance of their effects over time. On the other hand, a robotic solution controlled directly by a practitioner (ie, on-site telepresence system) enables greater adaptability to children's responses and choices during interventions. We believe that such a solution would enable better assessment of progress in the fundamental skills of expressive communication and imitation as well as greater engagement during interventions.

Methods and analysis: This is a prospective, monocentric, descriptive and evaluative pilot study based on single-case experimental design (SCED) methodology. The study will recruit eight children diagnosed with ASD aged between 2 and 5 years. The intervention will take place 15 min after the usual weekly care. The SCED methodology is constructed in three stages: (A) 4 weekly sessions at baseline without the robot, (B) 9 weekly sessions with intervention modification using a social robot as cotherapist and (C) 4 weekly sessions without the robot for follow-up.

Ethics and dissemination: Ethical approval was obtained from the South East IV Ethics Committee (CPP Sud-Est IV) (number: 2023-A00895-40) in France. Explicit consent is required from all legal representatives (parents) of children participating in this study. We aim to disseminate the results of this study through national and international conferences, international peer-reviewed journals and social media.

Trial registration number: NCT05991791.

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试点研究方案,采用单例实验设计,评估在丹佛干预期间与自闭症儿童进行远程机器人互动对交流技能的影响。
前言多年来,人们一直在研究社交机器人作为自闭症谱系障碍(ASD)儿童干预工具的作用。法国国家卫生局推荐的早期干预模式之一是 "早期开始丹佛模式",这是一项基于儿童选择的游戏活动的个性化强化计划。虽然近年来发表的研究表明,在临床环境中,机器人对自闭症儿童学习社交互动有好处,但对于机器人的广泛贡献和长期保持效果,科学界尚未达成共识。另一方面,由医生直接控制的机器人解决方案(即现场远程呈现系统)能更好地适应儿童在干预过程中的反应和选择。我们认为,这种解决方案可以更好地评估儿童在表达交流和模仿等基本技能方面的进步,并在干预过程中提高儿童的参与度:这是一项基于单例实验设计(SCED)方法的前瞻性、单中心、描述性和评价性试点研究。研究将招募八名被诊断为 ASD 的儿童,年龄在 2 至 5 岁之间。干预将在每周常规护理后 15 分钟进行。SCED方法分为三个阶段:(A) 每周4次基线治疗,不使用机器人;(B) 每周9次治疗,使用社交机器人作为治疗师对干预进行修改;(C) 每周4次随访,不使用机器人:该研究已获得法国东南第四伦理委员会(CPP Sud-Est IV)的伦理批准(编号:2023-A00895-40)。参与本研究的所有儿童的法定代理人(父母)必须明确表示同意。我们的目标是通过国内和国际会议、国际同行评审期刊和社交媒体传播本研究的结果:NCT05991791.
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来源期刊
BMJ Open
BMJ Open MEDICINE, GENERAL & INTERNAL-
CiteScore
4.40
自引率
3.40%
发文量
4510
审稿时长
2-3 weeks
期刊介绍: BMJ Open is an online, open access journal, dedicated to publishing medical research from all disciplines and therapeutic areas. The journal publishes all research study types, from study protocols to phase I trials to meta-analyses, including small or specialist studies. Publishing procedures are built around fully open peer review and continuous publication, publishing research online as soon as the article is ready.
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