Conclusions
Autism, hyperactivity, CM, impulsivity, ADHD, SE
RECRUITMENT
Our study represents the first randomized controlled trial of a nonwearable digital therapeutic intervention in preschoolers with ASD in China. Our data provide preliminary evidence that the intervention we have implemented using VR-CBT may confer a number of benefits such as significant changes in core symptoms and functions of sensory, motor, and response inhibition of preschoolers with ASD. VR-CBT also showed improvements in the symptoms, including impulsivity and hyperactivity in preschoolers with comorbid ADHD, compared to those in the control group. Although the positive significance of these findings remains to be confirmed in future studies, results from this trial underscore the potential of nonwearable digital therapy as an effective adjunctive therapy in preschoolers with ASD.This work was supported by the General Program of the National Natural Science Foundation (71874110), Major Research Plan Project of the National Natural Science Foundation (91846302), special key project for clinical research and cultivation of Shanghai Children’s Hospital affiliated to Shanghai Jiao Tong University School of Medicine (2021YLYZ02), project of the Shanghai Health and Hygiene Commission on Aging and Maternal and Child Health (2020YJZX0207), and 3-year action plan for the construction of the Shanghai public health system (GWV-10.1-XK14).Authors' Contributions: GY and YW created the concept of this study, developed the protocol for the research, took part in the virtual reality–incorporated cognitive behavioral therapy platform development, and offered financial and technical support for this trial. YT, JC, CZ, and ZG were responsible for participant recruitment and exclusion. ML, CW, and LP worked on the intervention and data collection. PZ and DW completed the preintervention and postintervention assessments. LC, LS, and CM performed data analysis and wrote the manuscript draft. GY and YW provided critical revisions in the manuscript. All authors approved the final version of this manuscript.LC, LS, and CM contributed equally to this work and should be considered joint first authors. GY (guangjunyu@cuhk.edu.cn) and YW (wy_rain@126.com) contributed equally to this work and should be considered joint corresponding authors.Conflicts of Interest: None declared.Process of the virtual reality–incorporated cognitive behavioral therapy intervention.Measurement of end point indicators at different time points.CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile eHealth Applications and Online Telehealth; version 1.6.1).Mean (SE) score change from the scores before the intervention to those after the intervention in the Autism Behavior Checklist of each group in the intention-to-treat population.