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Clinical Trials in Denmark / NCT06438536
Active, not recruiting Not applicable

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

NCT06438536 · tracked via the Priya Life Science Denmark tracker
Sponsor
University Hospital Bispebjerg and Frederiksberg
Phase
Not applicable
Started
2024-05-02
Last updated
2026-06-25

Condition(s) studied

Autism Spectrum Disorder

Investigational drug(s) / intervention(s)

Virtual Reality-based Social Cognitive Training

Virtual Reality-based Social Cognitive Training: Virtual reality assisted social cognitive training embedded in cognitive behavioral therapy, that aims at enhancing social cognition and daily life functioning.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age of 18 years or older 2. Ability to give informed consent 3. Diagnosis of an autism spectrum disorder (ICD-10 code F84.0; F84.1; F84.5; F84.8) 4. T-score on SRS-A self-report ≥ 60 Exclusion Criteria: 1. Rejecting informed consent 2. A diagnosis of organic brain disease 3. Intellectual disability (IQ ˂ 70) 4. A command of spoken Danish or English inadequate for engaging in therapy 5. ADHD-diagnosis with untreated symptoms 6. Displaying an imminent homicidal or suicidal risk

Primary outcome measure(s)

  • Social Responsiveness Scale, Adult Version, Self-report — Baseline, 3 month follow-up and 6 month follow-up
    The primary outcome is level of social impairment is measured by the Social Responsiveness Scale, Second Edition, Adult version, Self-report (SRS-2A) at cessation of treatment at 3-months. SRS-2A measures the presence and severity of social impairment in everyday life. The SRS-2A is a commonly used measure in autism spectrum research and has demonstrated good reliability and validity. SRS-2A is a 65-item rating scale, scored on on a 4-point Likert Scale (0-3). Each item is scaled from 0 (never true) to 3 (almost always true), generating a total score ranging from 0 to 195. The SRS-2A is provides a continuous measure of social impairment, where a higher score reflects a greater degree of difficulties with social interactions in everyday life. Follow-up assessments will comprise ratings of the previous two-week period.

Trial sites (1)

FacilityCityRegionStatus
Copenhagen Research Centre for Mental Health (CORE), Mental Health Centre Copenhagen, Mental Health Services in the Capital Region, Denmark Copenhagen Hellerup

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Other trials for the same condition

Paediatric Autism Communication Therapy (PACT) in Children With Autism Spectrum Disorder Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06438536 on ClinicalTrials.gov ↗ ← All trials in Denmark