Non-wearable digital therapy improves child outcomes in preschoolers with Autism spectrum disorder: an open-label, randomized controlled trial (Preprint)

BACKGROUND Autism spectrum disorder (ASD) is a neurodevelopmental disorder affecting patients of a variety of ages that can cause difficulty with communication and social interactions as well as complicated family dynamics. Digital health interventions, especially wearable digital therapies, can reduce treatment costs and promote healthy lifestyle changes for patients, and while these therapies can be adjunctive or they can even replace traditional treatments. However, issues with cooperation and compliance prevent preschool ASD patients from applying these tools. In this open-label, randomized controlled trial, we developed a non-wearable digital therapy, named Virtual Reality incorporated Cognitive Behavioral Therapy (VR-CBT). OBJECTIVE The aim of this study is to assess the adjunctive function of VR-CBT on preschool children with ASD through comparing the effect of receiving VR-CBT plus Learning Style Profile (LSP) intervention with LSP intervention alone. METHODS This randomized, controlled trial was done in Shanghai, China. A total of 78 children (aged 3–6 years, IQ over 70) diagnosed with ASD were randomized to receive a twenty-week VR-CBT plus LSP intervention (intervention group, 39/78, 50.0%) or LSP intervention only (control group, 39/78, 50.0%). The primary outcome was the change of scores from baseline to week 20, assessed by using the parent rating Autism Behavior Checklist (ABC). Secondary outcomes included the Childhood Autism Rating Scale (CARS), ADHD Rating Scale-IV (ADHD-RS-IV), and behavioral performance data (accuracy and reaction time) in Go/No-Go task. All primary and secondary outcomes were analyzed in the intention-to-treat population. RESULTS After a 20-week intervention, there was an intervention effect on total ABC (β=-5.528, P<.001) and CARS score (β=-1.365, P=.02); a similar trend was observed in ABC subscales: Sensory (β=-1.133, P=.047), Relating (β=-1.512, P=.03), Body and object use (β=-1.211, P=.03), 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). However, no statistically significant intervention effect was detec The findings show potentially positive effects of non-wearable digital therapy plus LSP on core symptoms associated with ASD, and lead to a modest improvement in function of sensory, motor and response inhibition, while reducing impulsivity and hyperactivity in those preschool autistics with comorbid ADHD. VR-CBT was found to be an effective and feasible adjunctive digital tool.ted in language subscale of ABC (β=-.080, P=.83). CONCLUSIONS The findings show potentially positive effects of non-wearable digital therapy plus LSP on core symptoms associated with ASD, and lead to a modest improvement in function of sensory, motor and response inhibition, while reducing impulsivity and hyperactivity in those preschool autistics with comorbid ADHD. VR-CBT was found to be an effective and feasible adjunctive digital tool. CLINICALTRIAL ChiCTR2100053165