Kuo Naichi, Yao Yukai, Ma Chenhuan, Chu Liting, Chen Jinjin, Wan Chunling, Wang Dandan, Lu Dingjie, Li Xiaoqian, Wang Yu
Department of Rehabilitation of Child Health Care Medical Division, Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Department of Child Health Care Medical Division, Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Front Psychiatry. 2025 Jun 13;16:1575695. doi: 10.3389/fpsyt.2025.1575695. eCollection 2025.
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. 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. 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.
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.
The primary aim of this trial is to determine the clinical effectiveness of cognitive training using VR technology in children with ASD.
Chinese Clinical Trial Registry identifier, ChiCTR2400094189.
自闭症谱系障碍（ASD）是一种神经发育疾病，有效的治疗选择有限，包括应用行为分析、经颅磁刺激以及某些旨在应对相关行为和情绪调节挑战的药物。主要干预措施包括教育培训和行为矫正。然而，缺乏长期、密集且个性化的康复训练策略，因此迫切需要开发新的康复工具。虚拟现实（VR）是一种有前景的数字康复工具，可能有助于许多患有ASD的儿童和青少年发展重要的生活技能，如社交沟通和日常生活能力。在此，我们介绍一项针对学龄前ASD儿童的初始多中心随机对照试验方案。该试验旨在研究利用VR技术对ASD幼儿进行行为训练的临床疗效。
总共160名4至7岁的高功能ASD儿童将按1:1的比例分配到试验组或对照组。试验组将接受基于VR技术的行为训练以及由康复团队指导的早期家庭干预，而对照组将接受由康复团队指导的早期家庭干预。两组均将连续12周每周进行两次试验或对照干预方式的 sessions。在试验开始时、整个干预阶段以及研究期间的随访间隔进行结果评估。
该试验的主要目的是确定使用VR技术对ASD儿童进行认知训练的临床有效性。
中国临床试验注册标识符，ChiCTR2400094189。 （注：原文中“sessions”未明确具体含义，可能是“课程”之类，这里保留原文未翻译）
