跳至主要内容
临床试验/NCT05991791
NCT05991791招募中不适用

Adapted and Individualized Intelligent Robotic Interactions to the Ability Spectrum of Children With Autism Spectrum Disorder

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年10月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
8
试验地点
1
主要终点
Score of success on the selected task in the ESDM program

研究概览

简要总结

For several years, studies have been developed on the contribution of social robots as a tool for interventions for children with autism spectrum disorders (ASD). One of the recommended intervention models is the ESDM (Early Start Denver Model). It consists of setting up an individualized, intensive program (at least 20 hours per week) through the pleasure of play. The teacher follows the motivation and interests of the child, and it is the child who chooses the activities. Studies published in recent years tend to show that robots bring benefits to ASD children, particularly in the treatment of social interactions and in clinical settings. However, there is no scientific consensus on the generalized contribution and effect over time of these interventions. Moreover, a robotic solution controlled by a practitioner through a telepresence system allows for a better adaptability to the responses and desires of the children during the interventions. The investigators believe that such a solution would allow for better assessment of progress in the core skills of expressive communication and imitation and greater engagement during interventions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patient living in the Hérault department (France),
  • Patient with a diagnosis of ASD confirmed by a psychiatrist or a psychologist and receiving current care according to the ESDM model in the MPEA Peyre Plantade child psychiatry service.

排除标准

  • Failure to obtain written informed consent after a cooling-off period
  • Participating in another type of program other than ESDM
  • Not being affiliated to a French social security system or being a beneficiary of such a system
  • Therapist
  • History of epilepsy for health professionals (therapists)

结局指标

主要结局

Score of success on the selected task in the ESDM program

时间窗: From phase A (baseline) to phase C (post-intervention) = 19 weeks

Measure the success score for the selected task using the ESDM scoring grid. As soon as the child successfully completes one of the different learning stages, a success score is given to the task. This score will be maximum if all the learning stages of the task considered have been reached (Task 1 = 6 learning stages (maximum score =6); Tasks 2 and 3 = 7 stages (maximum score =7)). The ESDM scoring grid will be completed by the research therapists at the end of each session.

次要结局

  • Time of the child's viewing and movement of the head and body towards the robot (task 1: saying "hello")(During Phase B = 11 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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