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NCT06438536Active, not recruiting

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

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.

Source: ClinicalTrials.gov · Last updated 25 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
140 (estimated)
First submitted
23 May 2024
Start date
2 May 2024
Primary completion date
15 Jul 2026
Lead sponsor
University Hospital Bispebjerg and Frederiksberg
Diseases
Autism
NCT number
NCT06438536

What you commit to

  • Study type: Interventional
  • Planned participants: 140
  • From 2 May 2024 to the primary completion date, 15 Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • A command of spoken Danish or English inadequate for engaging in therapy

Other illness

  • A diagnosis of organic brain disease

Other

  • Rejecting informed consent
  • Intellectual disability (IQ ˂ 70)
  • ADHD-diagnosis with untreated symptoms
  • Displaying an imminent homicidal or suicidal risk

Who the study is looking for

  • Age of 18 years or older
  • Ability to give informed consent
  • Diagnosis of an autism spectrum disorder (ICD-10 code F84.0; F84.1; F84.5; F84.8)
  • T-score on SRS-A self-report ≥ 60

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Copenhagen Research Centre for Mental Health (CORE), Mental Health Centre Copenhagen, Mental Health Services in the Capital Region, Denmark
Coordinator of this site? Confirm its status
CopenhagenDenmarkUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.