The Effect of Virtual Reality-Based Social Cognitive Training for Autistic Adults: Protocol for STEPS (Social Cognitive Training Enhancing Pro-Functional Skills) Randomized Clinical Trial.

Background: Autistic adults constitute a growing and largely overlooked population with limited clinical and research resources. Social cognitive impairments are key deficits faced by this population, significantly impacting social interactions, educational and vocational functioning, and quality of life. Interventions targeting social cognition in autistic adults have shown promising results. Recent studies investigating the effect of virtual reality (VR)-based interventions for autistic adults have provided preliminary evidence supporting the feasibility and effectiveness of using this innovative technology. These studies indicate that VR interventions can enhance functional and social skills and improve specific neurocognitive and social cognitive functions. However, large-scale randomized clinical trials are urgently needed to fully assess the effectiveness of VR-based interventions for autistic adults. Objective: This protocol aims to provide a comprehensive description of the design and methodology of the STEPS (Social Cognitive Training Enhancing Pro-Functional Skills) trial. Methods: STEPS is a clinical, randomized, assessor-blinded, parallel-group superiority trial. A total of 140 participants will be allocated to receive either virtual reality-based social cognitive training (VRSCT) + treatment as usual (TAU) or TAU alone. The experimental group will receive 12 weekly 1-hour sessions of VRSCT, aiming at improving psychosocial functioning and social cognition through exposure to virtual social environments. The intervention comprises 3 core modules, namely emotions, social understanding, and complex social interactions. The exact content and duration of TAU received by each participant will be mapped and documented upon trial completion. Assessments will be conducted at baseline, at cessation of the intervention (3 months post baseline), and at 6 months post baseline. Results: Participant enrollment began in May 2024. As of February 2025 (initial manuscript submission), 34 participants had been enrolled, increasing to 97 participants as of December 2025. Completion of enrollment is expected in April 2026. Data analysis is expected to begin in October 2026 following the final 6-month follow-up assessment. Results are anticipated in December 2026 and will be disseminated through peer-reviewed publications. Conclusions: To our knowledge, STEPS is the hitherto largest randomized clinical trial globally investigating the effect of VRSCT for autistic adults. The results of this innovative intervention approach may significantly advance research in the field of autism. VRSCT holds potential to improve psychosocial functioning, quality of life, and co-occurring clinical symptoms, and to reduce social cognitive deficits in autistic adults. Establishing evidence-based interventions is crucial for addressing the debilitating psychosocial challenges faced by this population, especially considering the absence of established gold-standard treatments.