Research design and patients
This is a single center retrospective cohort study conducted at Hongxinkang New Traditional Chinese Medicine Hospital in Tongren. We included 124 children with ASD who received treatment from January 2024 to October 2024. A total of 62 pediatric patients received FIVR combined with psychological and behavioral interventions. A matched cohort of 62 pediatric patients who received pure psychological and behavioral intervention was selected using a 1:1 manual matching approach. Matching was based on four key baseline characteristics: (1) age (± 1 year), (2) gender, (3) duration of diagnosis (disease duration), and (4) initial severity of ASD, as assessed by baseline CARS and ABC scores. The matching was performed by trained clinical staff blinded to post-intervention outcomes during retrospective chart review. Propensity score matching (PSM) was not applied due to the relatively small sample size, limited covariates, and the single-center nature of the dataset. All participants included in the analysis were successfully matched, and no cases were excluded due to matching failure. All included participants completed the full three-month intervention protocol and outcome assessments. No dropouts or losses to follow-up occurred during the study period. Baseline comparability between the two groups was confirmed by statistical testing (see Table 1), with no significant differences across matched variables. All procedures performed in study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee(s) and with the Helsinki Declaration (as revised in 2013). The informed consent was waived by the Ethics Review Board of Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital for the observational and retrospective nature.
Inclusion criteria: (1) Diagnosis of autism spectrum disorder (ASD) based on the DSM-5 diagnostic criteria, as assessed by licensed pediatric neurologists and developmental specialists through structured clinical interviews, behavioral observations, and developmental history reviews. Standardized diagnostic tools such as the Autism Diagnostic Observation Schedule (ADOS) or the Social Communication Questionnaire (SCQ) were not consistently administered due to clinical resource constraints at the time of data collection; [1] (2) Patients aged 3–12 with stable and conscious consciousness; (3) Complete clinical data. Exclusion criteria: (1) Patients with concomitant Asperger’s syndrome; (2) Individuals with combined schizophrenia; (3) Patients with delayed mental development; (4) Patients with combined epilepsy; (5) Patients with visual and auditory impairments; (6) Patients with a history of intracranial surgery or implantation of metal foreign bodies.
Intervention methods
Psychological and behavioral intervention
(1) Language practice. Inducing children to enhance communication through understanding language exercises, strengthening pronunciation, attention exercises, etc.; two times/week, 30 min/time. (2) Personal sensory integration practice. Adopting balance perception exercises, tactile exercises, and proprioceptive exercises to cultivate sensory integration abilities; three times/week, 30 min/time. (3) Group practice. Group-based activities (e.g., jigsaw puzzles, toy assembly, bead stringing, dancing) were conducted in sessions of 4 to 6 children, grouped based on developmental level and behavioral compatibility; two times/week, 30 min/time. (4) Personalized exercises. Design courses such as sports, games, painting, music, etc. based on the individual interests and preferences of the affected child; two times/week, 30 min/time. (5) Family practice. Invite the families of children with autism to actively participate in structured recreational activities; Accompany and guide children to actively participate in outdoor activities, enhance communication and emotional connections between children and their families. (6) Psychological intervention. Enhance communication with pediatric patients, maintain a warm, friendly, and supportive demeanor during therapist-child interaction, and create a warm and comfortable environment; And during communication, look into the eyes of the child and observe their expressions and changes in their gaze; Provide timely emotional support, psychological counseling, and comfort.
FIVR
All participants received a structured intervention program for a total duration of 12 weeks (3 months). The psychological and behavioral intervention (PBI) was conducted six sessions per week, while FIVR training was delivered 3 to 5 times weekly, depending on individual adaptability and availability.
(1) Evaluation phase. Initial assessment- Conduct a comprehensive evaluation of children with ASD, including personal-social (such as eye contact, perception of others’ presence, frequency of social interaction, etc.), communication skills (language expression, understanding instructions, etc.), repetitive stereotyped behaviors (such as frequency and intensity of clapping, shaking the body, etc.), and sensory sensitivity (response to sound, light, touch, etc.). Personalized needs analysis- Based on the evaluation results, analyze the child’s individual functional profile (e.g., sensory sensitivities, level of verbal communication, adaptive behavior). Based on these assessments, FIVR scenes were partially individualized, allowing customized selection of training modules to target specific developmental goals within the standardized VR framework; If the child is sensitive to visual stimuli, special attention should be paid to the selection and presentation intensity of visual elements when designing VR scenes. (2) VR scene design. Social scenarios- Create virtual social environments, such as virtual schools, virtual parks, etc.; Arrange virtual characters (with different appearances, genders, and age characteristics) to interact with children with autism in the virtual school scene; Virtual classmates can proactively greet children with autism and invite them to participate in activities (such as playing games, attending classes, etc.). Design multi person interactive plots in virtual park scenes; Gradually guide the children to participate in social interactions, such as flying kites or having picnics together; Improve their understanding and adaptive behavior to social situations; Communication scenario- Build a virtual scenario specifically designed for language and nonverbal communication training; In a virtual store scenario, the child needs to communicate with a virtual salesperson to purchase items; This includes expressing one’s own needs (such as the name and quantity of the item) and understanding the salesperson’s answers (such as price, availability, etc.). Non verbal communication scenarios can also be set up; Conveying emotions and intentions through facial expressions and body movements; At a virtual birthday party, the child needs to respond appropriately based on the expressions of others (happy, surprised, etc.) and body movements (hugging, waving, etc.). Sensory regulation scene- Create a virtual scene for sensory regulation for children with ASD who are sensitive to their senses; For children with auditory sensitivity, a quiet virtual forest environment with soft ambient sounds (e.g., breeze, birdsong) can be designed to facilitate gradual sensory adaptation. Design virtual tactile experience scenes for children with tactile sensitivity; If the child is allowed to touch different objects (soft feathers, rough bark, etc.) in a virtual environment to adjust their tactile sensitivity. (3) Rehabilitation training plan. Training frequency: 3–5 VR rehabilitation training sessions per week; The duration of each training session depends on the child’s attention and tolerance level; The initial stage can be set to 20–30 min, gradually extending to 40–60 min as the child’s adaptive behavior improves. Training steps- Warm up phase (5–10 min) – Before entering a specific rehabilitation scenario, allow the child to adapt to VR devices in a simple and relaxed virtual environment (such as a virtual children’s room); Observe the emotions and reactions of the child and engage in simple interactions with them; Such as selecting toys in the room through joystick operation. Rehabilitation training stage (10–40 min) – Based on the rehabilitation needs of the child, enter the corresponding scene for training. Relaxation stage (5–10 min) – After completing rehabilitation training, allow the child to return to a relaxed virtual environment; Like a virtual seaside, allowing children to stroll and watch the waves on the beach helps them relax and relieve stress during training. (4) Data monitoring and adjustment. Data collection- Collect various data of pediatric patients during VR rehabilitation training; Such as the number of social interactions, accuracy of language expression, frequency of repetitive stereotyped behaviors, heart rate, skin conductance response, etc. Assess the physiological and psychological state of the child during the training process. Plan adjustment- Analyze and adjust the rehabilitation plan on a weekly basis based on the collected data; If the child’s progress is not significant in a certain scene, or the number of interactions in the virtual social scene does not increase, the difficulty of the scene can be adjusted (such as increasing the number of virtual characters or changing the interaction mode) or the training method can be adjusted (such as increasing the frequency of prompts or changing the prompt mode).
Collect data
Collect baseline patient data, including gender, age, disease duration, and family background. Collect relevant evaluation indicators for patients before and 3 months after intervention: (1) behavioral status. According to the Autism Behavior Checklist (ABC) assessment [17]. It is completed by the primary nursing staff. The scale includes five aspects: sensation, relationship, stereotyped behavior, language, and social independence, with a critical value of 53 for ASD. (2) Severity of illness. The Childhood Autism Rating Scale (CARS) is used by developmental pediatricians to assess the severity of ASD and consists of 15 items [18]. Each project is rated on a continuum from normal to severely abnormal. A score of one indicates a normal range for age, two indicates a mild abnormality, three indicates a moderate abnormality, and four indicates a severe abnormality. The total score ranges from 15 to 60, with scores of 30–36 indicating mild ASD and 36 or more indicating severe ASD. (3) Neuropsychological function. According to the pediatric neuropsychological development assessment checklist, including personal-social, language, adaptive behavior, fine motor skills, and gross motor skills, higher scores indicated better functional performance; Using the developmental quotient as an indicator, < 70 points are considered developmental disorders, 70–79 points are considered critically low, 80–109 points are considered moderate, 110–130 points are considered good, and > 130 points are considered excellent. (4) Ability development level. According to the Psychoeducational Profile-third edition (PEP-3) assessment; [19] Including sensory response, imitation, cognitive expression, emotional expression, hand eye coordination, etc., a total of 166 points; The higher the score, the better the development of abilities. (5) Family satisfaction was investigated using the Newcastle Satisfaction with Nursing Scales (NSNS) after nursing care. The scale consisted of 19 items, with a total score of 95 points (five points for each item, three points for general satisfaction, and one point for dissatisfaction); Among them, a score of ≥ 76 indicates satisfaction, 56–75 indicates general satisfaction, and 19–55 indicates dissatisfaction. The number of patients with different levels of satisfaction will be counted; Nursing satisfaction=(number of satisfied cases + number of generally satisfied cases) / total cases × 100%.
The psychometric properties of the assessment tools used in this study have been well-established. The Aberrant Behavior Checklist (ABC) has demonstrated high internal consistency across subscales, with Cronbach’s α ranging from 0.86 to 0.94 in ASD populations. The Childhood Autism Rating Scale (CARS) exhibits excellent inter-rater reliability (r = 0.88–0.94) and internal consistency (Cronbach’s α ≈ 0.94), and its validity has been confirmed in Chinese clinical samples. The Psychoeducational Profile – Third Edition (PEP-3) shows robust psychometric characteristics, including internal consistency coefficients ranging from 0.82 to 0.96 and strong construct validity, as validated in simplified Chinese versions [19].
Statistical analysis
All data were input into Microsoft Excel and analyzed using SPSS version 26.0 (IBM Corp, Armonk, NY, USA). The Shapiro–Wilk test was applied to assess the normality of continuous variables. Given the non-normal distribution of most variables, continuous data (e.g., ABC, CARS, neurodevelopmental scores, and PEP-3 scores) were expressed as median and interquartile range. For between-group comparisons, the Mann–Whitney U test was used; for within-group comparisons (pre- vs. post-intervention), the Wilcoxon signed-rank test was applied. Categorical variables (e.g., gender, family satisfaction levels) were analyzed using chi-square tests. To account for potential baseline differences, analysis of covariance (ANCOVA) was conducted for the primary outcomes (ABC, CARS, and PEP-3), adjusting for covariates such as age, sex, diagnosis duration, and baseline severity. Effect sizes (Rank-biserial r or Cramér’s V for categorical data, and partial η² for ANCOVA models) were calculated and reported with 95% confidence intervals. Model assumptions were examined by QQ-plots and residual histograms, which are provided in Supplementary Figures S1–S6. Subdomain analyses of PEP-3 are summarized in Supplementary Table 1. GraphPad Prism version 8.0 (GraphPad Software, San Diego, USA) was used to visualize changes in outcome indicators over the three-month intervention period. A two-sided P-value < 0.05 was considered statistically significant.
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