Department of Child Health Care, Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Division of Child and Adolescent Health, Shanghai Municipal Center for Disease Control and Prevention, Shanghai, China.
J Med Internet Res. 2023 Aug 24;25:e45836. doi: 10.2196/45836.
Autism spectrum disorder (ASD) is a neurodevelopmental disorder that can cause difficulty with communication and social interactions as well as complicated family dynamics. Digital health interventions can reduce treatment costs and promote healthy lifestyle changes. These therapies can be adjunctive or replace traditional treatments. However, issues with cooperation and compliance prevent preschool patients with ASD from applying these tools. In this open-label, randomized controlled trial, we developed a nonwearable digital therapy called virtual reality-incorporated cognitive behavioral therapy (VR-CBT).
The aim of this study was to assess the adjunctive function of VR-CBT by comparing the effects of VR-CBT plus learning style profile (LSP) intervention with those of LSP-only intervention in preschool children with ASD.
This trial was performed in China on 78 preschool children (age 3-6 years, IQ>70) diagnosed with ASD who were randomized to receive a 20-week VR-CBT plus LSP intervention (intervention group, 39/78, 50%) or LSP intervention only (control group, 39/78, 50%). The primary outcome was the change of scores from baseline to week 20, assessed by using the parent-rated Autism Behavior Checklist (ABC). Secondary outcomes included the Childhood Autism Rating Scale (CARS), Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV), and behavioral performance data (accuracy and reaction time) in go/no-go tasks. All primary and secondary outcomes were analyzed in the intention-to-treat population.
After the intervention, there was an intervention effect on total ABC (β=-5.528; P<.001) and CARS scores (β=-1.365; P=.02). A similar trend was observed in the ABC subscales: sensory (β=-1.133; P=.047), relating (β=-1.512; P=.03), body and object use (β=-1.211; P=.03), and social and self-help (β=-1.593; P=.03). The intervention also showed statistically significant effects in improving behavioral performance (go/no-go task, accuracy, β=2.923; P=.04). Moreover, a significant improvement of ADHD hyperactivity-impulsivity symptoms was observed in 53 children with comorbid ADHD based on ADHD-RS-IV (β=-1.269; P=.02). No statistically significant intervention effect was detected in the language subscale of ABC (β=-.080; P=.83). Intervention group girls had larger improvements in ABC subscales, that is, sensory and body and object use and in the CARS score and accuracy of go/no-go task (all P<.05) than the control group girls. Statistically significant intervention effects could be observed in hyperactivity-impulsivity symptoms in the intervention group boys with comorbid ADHD compared with those in the control group boys (β=-1.333; P=.03).
We found potentially positive effects of nonwearable digital therapy plus LSP on core symptoms associated with ASD, leading to a modest improvement in the function of sensory, motor, and response inhibition, while reducing impulsivity and hyperactivity in preschoolers with both ASD and ADHD. VR-CBT was found to be an effective and feasible adjunctive digital tool.
Chinese Clinical Trial Registry ChiCTR2100053165; http://www.chictr.org.cn/showproj.aspx?proj=137016.
自闭症谱系障碍（ASD）是一种神经发育障碍，可导致沟通和社交互动困难以及复杂的家庭动态。数字健康干预措施可以降低治疗成本并促进健康的生活方式改变。这些疗法可以作为辅助治疗或替代传统治疗。然而，合作和依从性问题使得学龄前 ASD 患者无法应用这些工具。在这项开放性、随机对照试验中，我们开发了一种名为虚拟现实结合认知行为疗法（VR-CBT）的非穿戴式数字疗法。
本研究旨在通过比较 VR-CBT 联合学习风格特征（LSP）干预与仅 LSP 干预在学龄前 ASD 儿童中的附加作用，评估 VR-CBT 的附加功能。
该试验在中国进行，共纳入 78 名被诊断为 ASD 的学龄前儿童（年龄 3-6 岁，智商>70），随机分为接受 20 周 VR-CBT 联合 LSP 干预（干预组，39/78，50%）或仅 LSP 干预（对照组，39/78，50%）。主要结局为使用父母评定的自闭症行为检查表（ABC）评估从基线到第 20 周的评分变化。次要结局包括儿童自闭症评定量表（CARS）、注意力缺陷多动障碍评定量表-IV（ADHD-RS-IV）和 Go/No-Go 任务中的行为表现数据（准确性和反应时间）。所有主要和次要结局均在意向治疗人群中进行分析。
干预后，ABC 总分（β=-5.528；P<.001）和 CARS 评分（β=-1.365；P=.02）均有干预效应。ABC 子量表也观察到类似的趋势：感觉（β=-1.133；P=.047）、关系（β=-1.512；P=.03）、身体和物体使用（β=-1.211；P=.03）和社会和自我帮助（β=-1.593；P=.03）。干预在改善行为表现（Go/No-Go 任务，准确性，β=2.923；P=.04）方面也显示出统计学显著的效果。此外，根据 ADHD-RS-IV，在 53 名伴有 ADHD 的儿童中观察到 ADHD 多动冲动症状显著改善（β=-1.269；P=.02）。ABC 语言子量表的干预效果无统计学意义（β=-.080；P=.83）。与对照组女孩相比，干预组女孩在 ABC 子量表（即感觉和身体和物体使用）和 CARS 评分以及 Go/No-Go 任务的准确性方面的改善更大（均 P<.05）。与对照组男孩相比，伴有 ADHD 的干预组男孩的多动冲动症状有统计学显著的干预效应（β=-1.333；P=.03）。
我们发现非穿戴式数字治疗联合 LSP 可能对与 ASD 相关的核心症状有积极影响，导致学龄前 ASD 儿童的感觉、运动和反应抑制功能略有改善，同时降低了冲动性和多动性。VR-CBT 被发现是一种有效的、可行的辅助数字工具。
中国临床试验注册中心 ChiCTR2100053165；http://www.chictr.org.cn/showproj.aspx?proj=137016。
