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临床试验/NCT07330219
NCT07330219已完成不适用

The Effect of Fully Immersive Virtual Reality Technology Combined With Psychological and Behavioral Intervention on Autism Spectrum Disorder

Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Change in Childhood Autism Rating Scale (CARS) Total Score

研究概览

简要总结

To explore the effects of immersive virtual reality technology combined with psychological and behavioral intervention on children with autism. Methods: A retrospective study was conducted on the clinical data of 120 children with autism admitted to our hospital from January 2024 to October 2024. 58 children received psychological and behavioral intervention alone (control group), while 62 children received psychological and behavioral intervention combined with immersive virtual reality technology (study group). Disease severity (CARS),

详细描述

This is a single-center, retrospective interventional study evaluating the effects of fully immersive virtual reality combined with psychological and behavioral intervention in children with autism spectrum disorder. Clinical data were retrospectively collected from February 2024 to October 2024. Outcomes were assessed using standardized behavioral and developmental scales.

研究设计

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

入排标准

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

入选标准

  • Clinical diagnosis of autism spectrum disorder (ASD) according to DSM-5 criteria;
  • Age between 2 and 12 years;
  • Complete clinical and assessment data available.

排除标准

  • Diagnosis of schizophrenia or other psychotic disorders;
  • Severe intellectual disability preventing completion of assessments;
  • History of epilepsy or uncontrolled seizure disorders;
  • Significant visual or auditory impairment;
  • History of intracranial surgery or implantation of metallic foreign bodies.

研究组 & 干预措施

Fully Immersive Virtual Reality Combined With Psychological and Behavioral Intervention

Experimental

Participants receive fully immersive virtual reality (FIVR) training combined with standard psychological and behavioral intervention (PBI). The intervention lasts for 12 weeks. FIVR is delivered 3-5 times per week in addition to routine PBI.

干预措施: Fully Immersive Virtual Reality Training (Behavioral)

Fully Immersive Virtual Reality Combined With Psychological and Behavioral Intervention

Experimental

Participants receive fully immersive virtual reality (FIVR) training combined with standard psychological and behavioral intervention (PBI). The intervention lasts for 12 weeks. FIVR is delivered 3-5 times per week in addition to routine PBI.

干预措施: Psychological and Behavioral Intervention (Behavioral)

Psychological and Behavioral Intervention Only

Active Comparator

Participants receive standard psychological and behavioral intervention (PBI) alone for 12 weeks, including language training, sensory integration training, group activities, individualized training, family-based training, and psychological support.

干预措施: Fully Immersive Virtual Reality Training (Behavioral)

Psychological and Behavioral Intervention Only

Active Comparator

Participants receive standard psychological and behavioral intervention (PBI) alone for 12 weeks, including language training, sensory integration training, group activities, individualized training, family-based training, and psychological support.

干预措施: Psychological and Behavioral Intervention (Behavioral)

结局指标

主要结局

Change in Childhood Autism Rating Scale (CARS) Total Score

时间窗: Baseline and 12 weeks after initiation of intervention

The Childhood Autism Rating Scale (CARS) is a clinician-rated assessment consisting of 15 items, each scored from 1 to 4, with a total score range from 15 to 60. Higher scores indicate more severe autism-related symptoms (worse outcome). The outcome is defined as the change in total CARS score from baseline to the end of the 12-week intervention period.

次要结局

  • Change in Aberrant Behavior Checklist (ABC) Total Score(Baseline and 12 weeks)
  • Change in Psychoeducational Profile-Third Edition (PEP-3) Total Score(Baseline and 12 weeks)
  • Parental Satisfaction With Intervention(12 weeks)

研究者

发起方
Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province
申办方类型
Other
责任方
Principal Investigator
主要研究者

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Principal Investigator

Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province

研究点 (1)

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