背景: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。数字健康干预可以降低治疗成本,促进健康生活方式的改变。这些疗法可以是辅助治疗或替代传统治疗。然而,合作和依从性问题阻止ASD学龄前患者应用这些工具。在这个开放标签中,随机对照试验,我们开发了一种非穿戴式数字疗法,称为虚拟现实结合认知行为疗法(VR-CBT).
目的:本研究的目的是通过比较VR-CBT加学习风格简介(LSP)干预与仅LSP干预对学龄前ASD儿童的影响来评估VR-CBT的辅助功能。
方法:本试验在中国对78名学龄前儿童(3-6岁,IQ>70)诊断为ASD,随机接受20周VR-CBT加LSP干预(干预组,39/78,50%)或仅LSP干预(对照组,39/78,50%)。主要结果是通过使用父母评估的自闭症行为清单(ABC)评估从基线到第20周的得分变化。次要结果包括儿童自闭症评定量表(CARS),注意缺陷/多动障碍量表-IV(ADHD-RS-IV),和执行/不执行任务中的行为表现数据(准确性和反应时间)。在意向治疗人群中分析所有主要和次要结果。
结果:干预后,对总ABC(β=-5.528;P<.001)和CARS评分(β=-1.365;P=.02)有干预效果。在ABC子量表中观察到类似的趋势:感觉(β=-1.133;P=0.047),相关(β=-1.512;P=0.03),身体和物体使用(β=-1.211;P=0.03),以及社交和自助(β=-1.593;P=0.03)。干预措施在提高行为表现方面也显示出统计学上显著的效果(去/不去任务,准确度,β=2.923;P=.04)。此外,根据ADHD-RS-IV,在53例患有ADHD的儿童中观察到ADHD多动-冲动症状的显著改善(β=-1.269;P=.02).在ABC的语言分量表(β=-.080;P=.83)中未检测到有统计学意义的干预效果。干预组女孩在ABC量表中有较大的改善,也就是说,感觉和身体和对象的使用以及在CARS评分和准确性的去/不去任务(所有P<0.05)比对照组女孩。与对照组男孩相比,干预组男孩患有多动症的多动症症状的干预效果具有统计学意义(β=-1.333;P=0.03)。
结论:我们发现非穿戴式数字治疗加LSP对与ASD相关的核心症状有潜在的积极影响,导致感觉功能的适度改善,电机,和反应抑制,同时减少ASD和ADHD学龄前儿童的冲动和多动症。VR-CBT被认为是一种有效且可行的辅助数字工具。
背景:中国临床试验注册ChiCTR2100053165;http://www.chictr.org.cn/showproj.aspx?proj=137016。
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.