STEPS: A Virtual Reality-based Intervention for Adults With Autism. — STEPS  

Autism Spectrum Disorder Clinical Trial

Official title: STEPS (Social Cognitive Training Enhancing Pro-functional Skills): A Clinical Randomized Trial Evaluating the Effect of a Virtual Reality-based Intervention for Adults With Autism.

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to learn if a new Virtual Reality-based intervention will be effective in treating social cognitive challenges in adults with autism.

The main questions it aims to answer are:

1. Is Virtual Reality-based social cognitive training effective in reducing social cognitive deficits and improving psychosocial functioning, quality of life, and clinical symptoms in adults with ASD?

2. Is Virtual Reality-based social cognitive training cost-effective?

Researchers will compare Virtual Reality-based pro-functional, Social Cognitive Training (VRSCT) to treatment as usual (TAU) to evaluate effectiveness.

Participants will be allocated to receive either VRSCT once a week in addition to treatment as usual (TAU) or TAU alone for 3 months. All participants will undergo a thorough assessment at baseline, and at 3 and 6 months post-baseline.

Clinical Trial Description

Adults with autism spectrum disorders (ASD) constitute an increasingly recognized population with largely unaddressed public health needs. Research on effective interventions for adults with ASD lags far behind that dedicated to children with ASD, as well as other psychiatric disorders.

Adults with ASD show prominent social cognitive deficits that impede their daily functioning such as being able to interact socially, to achieve adequate vocational functioning (i.e. job/educational achievements) as well as inflicting immensely on their quality of life. At current, no robust and replicated evidence exists on a pro-functional treatment targeting social cognitive deficits in adults with ASD.

Virtual reality-based treatment offers the possibility of creating artificial experiences in real time, that make the user feel immersed and able to interact as if it was the real world. Additionally, virtual reality therapy allows for personalization of the therapy to match the specific social challenges of each patient.

Preliminary findings suggest virtual reality exposure to lead to faster symptom reduction than traditional therapy and may therefore be cost-effective. While the potential beneficial effects of virtual reality exposure to challenging social situations, that taps social cognitive functions, are evident and virtual reality therapies are promising in general, the research field is in urgent need of evidence on the effectiveness of virtual reality therapy in adults with ASD.

The STEPS trial evaluates the effect of a Virtual Reality-based pro-functional, Social Cognitive Training (VRSCT) versus treatment as usual. We expect to find VRSCT to be more beneficial in improving social cognitive deficits, daily life functioning, and quality of life in adults with ASD.

If the results of the current trial are positive, this short-term, manualised treatment using well-tested VR-software, can easily be implemented in clinical practice, that is in the psychiatric out-patient facilities or in community-based facilities where it can benefit a large group of suffering ASD patients. Additionally, it can be adapted for use in related clinical target groups such as adolescents with ASD or patients with psychosis experiencing social cognitive and functional deficits. ;

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

• NCT number: NCT06438536
• Study type: Interventional
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: Johannes Andresen, MSc Psych
• Phone: 20360116
• Email: johannes.andresen@regionh.dk
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2024
• Completion date: July 1, 2026