跳至主要内容
临床试验/NCT06130293
NCT06130293招募中不适用

The Effect of Daily Executive Function Training in School-aged Children With Autism Spectrum Disorder

National Taiwan Normal University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Questionnaire of executive function

研究概览

简要总结

Many studies support that children with autism spectrum disorder (ASD) show executive dysfunction. The applicant's NSC project report also indicated that in all areas in the behavior rating inventory of executive function, the second edition (BRIEF-2), including inhibit, self-monitor, shift, emotional control, initiate, working memory, plan/organize, task-monitor, and organization of materials, children in the typically developmental group showed better performance than children in the ASD group. The results also indicated that compared to the diagnosis of ASD, an executive function could be a better predictor of daily life adaptation. Similarly, more and more researchers put their efforts into executive training. However, the results are mixed. A meta-analysis showed that technology-based training can effectively improve the executive function of children with ASD. Children with ASD love game-like training as it provides friendly environments to children with ASD and induces less anxiety. The applicant, therefore, plans to develop a virtual reality executive function training program in the first year based on the applicant's previous experience with executive function training. The game will include the components of visual searching, reaction time, shift, planning, and working memory. At the end of the game, the game will provide visual feedback to the children to train in self-monitoring. In the second year, the applicant will conduct a randomized controlled trial to investigate the effectiveness of the training program. I plan to include 70 children with ASD and randomly assign them to either the executive training or control groups. Executive function and daily life adaptation will be the indexes of the effectiveness of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •diagnosed with ASD by a qualified healthcare professional
  • •meeting the ASD criteria by using ADOS-2
  • •IQ higher than 80.

排除标准

  • •not meeting the ASD criteria by using ADOS-
  • •IQ lower than
  • •comorbid physical and/or motor disabilities.
  • •comorbid mental disabilities except ADHD.

研究组 & 干预措施

Waiting list group

No Intervention

VR training

Experimental

Using VR training. 40 minutes per session, one session per week, and a total 8 weeks.

干预措施: VR game intervention (Device)

结局指标

主要结局

Questionnaire of executive function

时间窗: Week 0 (pre-intervention), Week 9 (post-intervention), and follow-up (Week 18 to Week 26)

parent's and teacher's forms

次要结局

  • Questionnaire of adaptive behaviors(Week 0 (pre-intervention), Week 9 (post-intervention), and follow-up (Week 18 to Week 26))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meng-Ting Chen

Assistant professor

National Taiwan Normal University

研究点 (1)

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