JMIR Publications

ABSTRACT

Background:

Autistic adults (AA) 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 AA, have shown promising results. Recent studies investigating the effect of virtual reality (VR)-based interventions for AA have provided preliminary evidence supporting the feasibility and effectiveness of utilizing 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, randomised, clinical trials are urgently needed to fully assess the effectiveness of VR-based interventions for AA.

Objective:

This protocol aims to provide a comprehensive description of the design and methodology of the STEPS trial.

Methods:

STEPS is a clinical, randomised, assessor-blinded, parallel-group superiority trial. A total of 140 participants will be allocated to receive either VR-based social cognitive training (VRSCT) + treatment as usual (TAU), or TAU alone. The experimental group will receive 12 weekly, one-hour sessions of VRSCT, aiming at improving psychosocial functioning and social cognition through exposure to virtual social environments. The intervention comprises three core modules: 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:

The trial is currently recruiting participants. The first participant was enrolled in May 2024. Completion of recruitment is expected in January 2026. Data analysis is expected to commence in summer 2026, following the final six-month follow-up assessment. Results are anticipated by fall 2026 and will be disseminated at international conferences and through peer-reviewed publications.

Conclusions:

To our knowledge, STEPS is the hitherto largest randomised clinical trial globally investigating the effect of VRSCT for AA. 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, co-occurring clinical symptoms and reduce social cognitive deficits in AA. 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. Clinical Trial: Registered at ClinicalTrials.gov (ID: NCT06438536). https://clinicaltrials.gov/study/NCT06438536?term=NCT06438536&rank=1