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临床试验/NCT06443320
NCT06443320招募中不适用

Evaluation of the Videodrama Therapeutic Device for Children With Autism Spectrum Disorders

Centre Hospitalier Intercommunal Robert Ballanger2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年12月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
Dunn Sensory Profile questionnaire

研究概览

简要总结

Autism spectrum disorder (ASD) is a neurodevelopmental disorder (Valerie, Sperenza, 2009) that begins early in development, characterized by persistent deficits in communication and social interactions across various contexts and restricted, repetitive patterns of behavior, interests, or activities. These symptoms significantly impact social, school/professional functioning, or other important areas and are not better explained by intellectual disability or global developmental delay (American Psychiatric Association, 2013).

详细描述

Currently, managing children with ASD emphasizes compensating for communication and social interaction disabilities. Communication tools like PECS or Makaton and social skills groups have shown effectiveness but have limitations, particularly not addressing sensory atypicalities seen in children with ASD. These sensory atypicalities are evident when children watch videos on screens. The idea is to use video to understand the sensory experiences of children with ASD and help them move away from an isolated relationship with screens. New technologies can further isolate children with ASD in their autistic sphere. The hypothesis is that observing these children with screens will provide better understanding of their sensory experiences and improve therapeutic support towards play and interaction with others

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
3 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 3 to 15 years.
  • Clinically confirmed ASD by a psychiatrist.
  • Parental or legal guardian consent for participation.
  • Child showing a strong interest in screens and/or video content.
  • Ability to tolerate the presence of other children.
  • Minimum of 18 video drama sessions.
  • Not having benefited from disease care in the past.
  • Affiliation to a social security system

排除标准

  • No ASD diagnosis.
  • Younger than 3 or older than 15 at the study start.
  • No interest in screens or video content.
  • Parental or legal guardian refusal for participation.
  • Dropping out before completing 18 sessions.
  • Patient having benefited a disease care in the past

结局指标

主要结局

Dunn Sensory Profile questionnaire

时间窗: 9 months

Sensory atypicality frequency will be assessed using the Dunn Sensory Profile questionnaire, describing child behavior in various sensory experiences

次要结局

  • Cars-T questionnaire(9 months)
  • Sceno Test(9 months)

研究者

发起方
Centre Hospitalier Intercommunal Robert Ballanger
申办方类型
Other
责任方
Sponsor

研究点 (2)

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