Comparative Outcomes of VR and In-person Interventions for Preschool-aged Children With Autism Spectrum Disorder

NCT07594171 | Completed

• 1 other identifier: NCKU_IBM_TLL_ASD_VR
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether a virtual reality (VR)-based social skills intervention works as well as an in-person group intervention for improving social skills in preschool children with autism spectrum disorder (ASD) without intellectual disability. It will also examine how these two approaches may differ in their effects across different settings. The main questions it aims to answer are: Do children who receive the VR-based intervention show improvements in social skills over time? Are there differences in outcomes between children receiving the VR-based intervention and those receiving the in-person group intervention? Researchers will compare a VR-based social skills intervention to an in-person group-based intervention with equivalent content to see if the mode of delivery affects treatment outcomes. Participants will: Be randomly assigned to either a VR-based intervention group or an in-person group intervention Participate in 8 weekly sessions, each lasting approximately 50 minutes Engage in structured, play-based social skills activities designed using naturalistic developmental behavioral intervention (NDBIs) principles Complete caregiver- and teacher-reported questionnaires before and after the intervention

Conditions

Autism Spectrum Disorder High-Functioning; Autism Spectrum Disorder (ASD)

Keywords

Social Skills; Group-based intervention; preschool children; Head-mounted display; virtual reality; Naturalistic developmental behavioral interventions; Autism spectrum disorder

Outcome Measures

Primary Outcomes (2)

• Social Responsiveness Scale, Second Edition (SRS-2)

  The Social Responsiveness Scale, Second Edition (SRS-2; Constantino \& Gruber, 2005) was used to assess social awareness, social communication, and restricted behaviors. The SRS-2 demonstrates high internal consistency (α = 0.94-0.97) and acceptable convergent validity (r = 0.64-0.86). In our study, SRS-2 is a caregiver- and teacher-reported measure assessing social impairment associated with autism spectrum disorder. The total score reflects overall social responsiveness, with higher scores indicating greater impairment. Changes from baseline to post-intervention will be analyzed.

  Pre-intervention (baseline) and immediately post-intervention (8 weeks)

• Vineland Adaptive Behavior Scales, Third Edition (VABS-3) Communication and Socialization Domains

  The Vineland Adaptive Behavior Scales, Third Edition (VABS-3, Chinese version; Sparrow et al., 2016; Chang et al., 2020) was administered to evaluate adaptive functioning across communication, daily living skills, and socialization. The Chinese version demonstrates strong reliability (split-half α = 0.87-0.99) and construct validity (0.48-0.93). In the present study, analyses focused on the Communication and Socialization domains, reported by caregiver and teacher, which are most directly relevant to social-communication outcomes targeted by the intervention.

  Pre-intervention (baseline) and immediately post-intervention (8 weeks)

Secondary Outcomes (1)

• VABS-3 Maladaptive Behavior Index

  Pre-intervention (baseline) and immediately post-intervention (8 weeks)

Study Arms (2)

Virtual Reality Social Skills Group Intervention

EXPERIMENTAL

Participants receive a virtual reality (VR)-based social skills intervention grounded in Naturalistic Developmental Behavioral Interventions (NDBIs). The program consists of 8 weekly sessions (approximately 50 minutes each) delivered in an immersive virtual environment. The intervention includes structured social interaction scenarios, hierarchical prompting, and individualized feedback to support the development of social communication and emotional regulation skills.

Behavioral: Virtual Reality-Based Social Skills Group Intervention

In-Person Social Skills Group Intervention

ACTIVE COMPARATOR

Participants receive an in-person group-based social skills intervention grounded in Naturalistic Developmental Behavioral Interventions (NDBIs). The program consists of 8 weekly sessions (approximately 50 minutes each), with matched content, session structure, prompting strategies, and reinforcement principles to ensure equivalence with the VR intervention.

Behavioral: In-Person Social Skills Group Intervention

Interventions

Virtual Reality-Based Social Skills Group Intervention BEHAVIORAL

This intervention is a virtual reality (VR)-based social skills training program grounded in Naturalistic Developmental Behavioral Interventions (NDBIs). The program consists of 8 weekly sessions (approximately 50 minutes each) delivered via a head-mounted display in an immersive virtual environment. The intervention incorporates structured social interaction scenarios, hierarchical prompting, prompt fading, and individualized reinforcement. Real-time feedback is provided based on participant responses to support the development of social communication, emotional understanding, and behavioral regulation. The intervention content, session structure, and therapeutic principles are designed to be equivalent to the in-person intervention condition.

Also known as: NDBIs-informed Social Skills Group Intervention

Virtual Reality Social Skills Group Intervention

In-Person Social Skills Group Intervention BEHAVIORAL

This intervention is an in-person group-based social skills training program grounded in Naturalistic Developmental Behavioral Interventions (NDBIs). The program consists of 8 weekly sessions (approximately 50 minutes each), conducted in small groups and led by trained clinicians. The intervention includes naturalistic social interaction activities, hierarchical prompting, prompt fading, and individualized reinforcement. Therapists provide real-time modeling, feedback, and scaffolding based on participants' responses. The intervention content, session structure, and therapeutic principles are matched to those of the VR-based intervention to ensure equivalence across conditions.

Also known as: NDBIs-informed In-Person Social Skills Group Intervention

In-Person Social Skills Group Intervention

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4 to under 7 years
• Full Scale IQ (FSIQ) ≥ 70 and Verbal Comprehension Index (VCI) ≥ 70
• Score ≥ 15 on the Checklist for Autism Spectrum Disorder-Chinese Version (CASD-C)
• Classification of Autism Spectrum Disorder based on Autism Diagnostic -Observation Schedule, Second Edition (ADOS-2)
• Clinical diagnosis of Autism Spectrum Disorder by a licensed clinician

You may not qualify if:

• Significant sensory or motor impairments (e.g., severe visual or hearing impairments, major physical disabilities)
• Known genetic or neurological conditions (e.g., epilepsy, fragile X syndrome, traumatic brain injury)
• Severe behavioral or emotional problems that would interfere with participation in interventions

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Tainan City, 701, Taiwan

Location

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MeSH Terms

Conditions

Autism Spectrum Disorder; Social Skills

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants, caregivers, and intervention providers are aware of group assignment due to the nature of the interventions. Outcome measures are reported by caregivers and teachers who are not involved in intervention delivery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study employs a parallel-group randomized controlled design to compare the efficacy of a virtual reality (VR)-based social skills intervention and an equivalent in-person group intervention grounded in Naturalistic Developmental Behavioral Interventions (NDBIs). Preschool children with autism spectrum disorder are randomly assigned to one of the two intervention groups. Both interventions consist of 8 weekly sessions (approximately 50 minutes each), with matched content, session structure, prompting hierarchies, and reinforcement strategies to ensure treatment equivalence. Outcomes are assessed at pre- and post-intervention using standardized caregiver- and teacher-reported measures of social skills and adaptive behaviors.

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start: December 6, 2023
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: May 18, 2026

Record last verified: 2026-04

Locations

TW (1)