Virtual reality 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.
This study is testing if a virtual reality program can help adults with autism improve their social skills and overall well-being when used alongside regular treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital Academic / other |
| Locations | 1 site (Copenhagen, Hellerup) |
| Trial ID | NCT06438536 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a Virtual Reality-based Social Cognitive Training (VRSCT) for adults with Autism Spectrum Disorder (ASD). Participants will be randomly assigned to receive either VRSCT alongside standard treatment or standard treatment alone for three months. The study will assess improvements in social cognitive deficits, psychosocial functioning, quality of life, and clinical symptoms through thorough evaluations at baseline, and at three and six months post-baseline. The trial also seeks to determine the cost-effectiveness of this innovative intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with Autism Spectrum Disorder who can provide informed consent.
Not a fit: Patients with untreated ADHD symptoms, organic brain disease, or significant intellectual disabilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve social cognitive skills and overall quality of life for adults with autism.
How similar studies have performed: Preliminary findings in similar virtual reality therapies suggest potential effectiveness, but this specific approach for adults with ASD is novel and largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen, Hellerup
- Copenhagen Research Centre for Mental Health (CORE), Mental Health Centre Copenhagen, Mental Health Services in the Capital Region, Denmark — Copenhagen, Hellerup, Denmark (Recruiting)
Study contacts
- Principal investigator: Louise B. Glenthøj, DrMSc — Copenhagen Research Centre for Mental Health (CORE), Mental Health Centre Copenhagen
- Study coordinator: Johannes Andresen, MSc Psych
- Email: johannes.andresen@regionh.dk
- Phone: 20360116
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.