Efficacy of non-wearable VR-based behavioral training for preschool children with high-functioning autism spectrum disorder: A protocol for an upcoming randomized clinical trial

Naichi Kuo¹Yukai Yao¹Chenhuan Ma²Liting Chu³Jinjin Chen²Chunling Wan⁴Dandan Wang⁴Dingjie Lu¹Xiaoqian Li¹Yu Wang^1*

• ¹Department of Rehabilitation of Child Health Care Medical Division, Shanghai Children’s Hospital, School of medicine, Shanghai Jiao Tong University, Shanghai, China, Shanghai, China
• ²Department of Child Health Care Medical Division, Shanghai Children’s Hospital, School of medicine, Shanghai Jiao Tong University, Shanghai, China, shanghai, China
• ³Institute of Child and Adolescent Health, Shanghai Municipal Center for Disease Control and Prevention, Shanghai, China
• ⁴Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Bio-X Institutes, Shanghai Jiao Tong University, Shanghai, China

Objective: Autism spectrum disorder (ASD) is a neurodevelopmental condition with limited effective treatment options, including Applied Behavior Analysis, Transcranial Magnetic Stimulation, and certain medications aimed at managing associated behavioral and emotional regulation challenges.that currently lacks effective treatments. Primary interventions include educational training and behavioral modifications. However, long-term, intensive, and individualized rehabilitation training strategies are lacking, and new rehabilitation tools therefore urgently need to be developed. Virtual reality (VR) is a promising digital rehabilitation tool that may support the development of essential life skills, such as social communication and daily living abilities, in many children and adolescents with ASD. a powerful digital rehabilitation tool that effectively enhances the clinical outcome of ASD in children and adolescents. Herein, we introduce a protocol for an initial multicenter randomized controlled trial focused on preschool-aged children with ASD. This trial aims to investigate the clinical efficacy of behavioral training for young children with ASD utilizing VR technology.Methods: A total of 160 children aged 4-7 years with high-functioning ASD will be assigned to either the trial or control group in a 1:1 ratio. The trial group will undergo behavioral training based on VR technology and early family intervention guided by the rehabilitation team, whereas the control group will undergo early family intervention guided by the rehabilitation team. Both arms will undergo twice weekly sessions of either the trial or control intervention modality performed over 12 consecutive weeks. Outcome assessments will be performed at the start of the trial, throughout the intervention phase, and at follow-up intervals during the study.Discussion: The primary aim of this trial is to determine the clinical effectiveness of cognitive training using VR technology in children with ASD.Clinical Trial Registration: tion: The study is ongoing and has been registered at the Chinese Clinical Trial Registry (ChiCTR2400094189) on 18/12/2024.