Trials
Search / Trial NCT06438536

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

Launched by MENTAL HEALTH SERVICES IN THE CAPITAL REGION, DENMARK · May 30, 2024

Trial Information

Current as of February 12, 2025

Recruiting

Keywords

Randomized Clinical Trial (Rct) Virtual Reality (Vr) Social Cognitive Training Cognitive Remediation Digital Intervention

ClinConnect Summary

The STEPS clinical trial is exploring whether a new Virtual Reality-based training program can help adults with Autism Spectrum Disorder (ASD) improve their social skills and overall well-being. The researchers want to find out if this Virtual Reality training can make a real difference in how people with autism interact socially, feel about their lives, and manage their symptoms. They will compare the effects of this new training to standard treatment that participants usually receive.

To participate in the trial, individuals need to be at least 18 years old and have a diagnosis of autism. They should also be able to understand and agree to take part in the study. Participants will be assigned to either receive the Virtual Reality training once a week alongside their usual treatment or just continue with their usual treatment for three months. Throughout the trial, researchers will check in with participants at the beginning, and again at three and six months, to see how they are doing. This study is currently looking for volunteers, and both men and women are welcome to join.

Gender

ALL

Eligibility 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

Trial Officials

Louise B. Glenthøj, DrMSc

Principal Investigator

Copenhagen Research Centre for Mental Health (CORE), Mental Health Centre Copenhagen

About Mental Health Services In The Capital Region, Denmark

The Mental Health Services in the Capital Region of Denmark is a leading clinical trial sponsor dedicated to advancing psychiatric research and improving mental health care delivery. Operating within a robust healthcare framework, the organization focuses on innovative treatment methodologies and evidence-based practices, collaborating with multidisciplinary teams to conduct rigorous clinical trials. By prioritizing patient-centered outcomes and leveraging cutting-edge technology, the Mental Health Services aim to enhance therapeutic interventions and contribute to the global understanding of mental health disorders. Their commitment to research excellence fosters a culture of continuous improvement and collaboration, ultimately striving to elevate the standards of mental health services in the region and beyond.

Locations

Copenhagen, Hellerup, Denmark

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0