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
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Copenhagen Research Centre for Mental Health (CORE), Mental Health Centre Copenhagen, Mental Health Services in the Capital Region, Denmark
RECRUITING
Copenhagen
Contact Information
Primary
Johannes Andresen, MSc Psych
johannes.andresen@regionh.dk
20360116
Backup
Alberte Cathrine E. Jeppesen, MSc Psych
alberte.cathrine.ehrhardt.jeppesen@regionh.dk
20311064
Time Frame
Start Date: 2024-05-02
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 140
Treatments
Experimental: Virtual Reality-based Social Cognitive Training (VRSCT)
Patients in the experimental group will be offered 10 individual sessions of targeted, virtual reality assisted psychotherapy embedded in cognitive behavioral therapy (CBT), that aims at enhancing social cognition and daily life functioning. If the patient consents, two additional sessions will be offered in which the patient's relatives are invited to participate (one in the beginning of treatment and one at the end of treatment). The aim of the relative involvement is to enhance transfer from the therapy to the patients daily life. The treatment will be conducted by psychologists with an extensive knowledge in providing virtual reality assisted therapy. The treatment is manualized, and the therapists will receive ongoing supervision by a senior clinician having ≥ 25 years of experience in conducting assessment, treatment, and research with the autism spectrum population.
No_intervention: Treatment as Usual (TAU)
The treatment-as-usual (TAU) group will receive the standard treatment offered to adults diagnosed with ASD in Denmark. This commonly consists of four psychoeducational sessions as well as limited supportive counseling. Some adults with ASD also receive practical help in daily life situations in community settings. The TAU will be mapped upon trial completion.
Related Therapeutic Areas
Sponsors
Leads: Mental Health Services in the Capital Region, Denmark

This content was sourced from clinicaltrials.gov