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临床试验/NCT05752994
NCT05752994招募中不适用

Effect of Multisensory Environment Room on Behavior in Children With Autism Spectrum Disorder

Mahidol University4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月9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
30
试验地点
4
主要终点
Vineland Adaptive Behavior Scales-Third Edition (VABS-III)

研究概览

简要总结

To investigate the effect of multisensory environment room on behavior in children with autism spectrum disorder age 3-5 years old. The children will be randomized into 2 groups: the experimental and the control group. The control group will be educated about the autistic and hoe program training. The intervention group will got the same educational program as the control group plus training in multisensory room environment once a week for 10 weeks. The outcome measurement was done as the before intervention, at the 5th and 10th week.

详细描述

This project is a pilot 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
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • the children who was diagnosed with autism according to DSM-5
  • age 3-5 years old
  • has the severity mild-to-moderate and severe according to childhood autism rating scale, 2nd edition

排除标准

  • The guardians deny to enroll into the study.
  • blindness, deafness
  • got the treatment of r-TMS less than 1 year

结局指标

主要结局

Vineland Adaptive Behavior Scales-Third Edition (VABS-III)

时间窗: baseline, change from baseline at 5 weeks, change from baseline at 10 weeks

To measure communication, interpersonal skill and relationship of the children with autistm spectrum and other people in scales; 2 = often, 1= sometimes and 0= never. The minimum score is o. The max score in receptive domain is 78. The max score of expressive domain is 98. The max score of written domain is 76. The max score of personal domain is 110. The max score of domestic domain is 60. The max score of community domain is 116. The interpersonal relationships domain max score is 86. The max score of play and leisure domain is 72. The max score of copling skill domain is 66. The max score of gross motor domain is 86. The max score of fine motor domain is 68. The max score of maladaptive behavior domain is 88.

次要结局

  • Parent Stress Index 4th Edition: Short Form [PSI-4-SF](baseline, change from baseline at 5 weeks, change from baseline at 10 weeks)

研究者

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

Sivaporn Vongpipatana

Assistant Professor

Mahidol University

研究点 (4)

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