Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438536
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-23
Brief Title:
STEPS A Virtual Reality-based Intervention for Adults With Autism
Sponsor:
Mental Health Services in the Capital Region Denmark
Organization:
Mental Health Services in the Capital Region Denmark
Study Overview
Official Title:
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEPS
Brief 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
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
Detailed Description:
Adults with autism spectrum disorders ASD constitute an increasingly recognized population with largely unaddressed public health needs Research on effective interventions for adults with ASD lags far behind that dedicated to children with ASD as well as other psychiatric disorders
Adults with ASD show prominent social cognitive deficits that impede their daily functioning such as being able to interact socially to achieve adequate vocational functioning ie jobeducational achievements as well as inflicting immensely on their quality of life At current no robust and replicated evidence exists on a pro-functional treatment targeting social cognitive deficits in adults with ASD
Virtual reality-based treatment offers the possibility of creating artificial experiences in real time that make the user feel immersed and able to interact as if it was the real world Additionally virtual reality therapy allows for personalization of the therapy to match the specific social challenges of each patient
Preliminary findings suggest virtual reality exposure to lead to faster symptom reduction than traditional therapy and may therefore be cost-effective While the potential beneficial effects of virtual reality exposure to challenging social situations that taps social cognitive functions are evident and virtual reality therapies are promising in general the research field is in urgent need of evidence on the effectiveness of virtual reality therapy in adults with ASD
The STEPS trial evaluates the effect of a Virtual Reality-based pro-functional Social Cognitive Training VRSCT versus treatment as usual We expect to find VRSCT to be more beneficial in improving social cognitive deficits daily life functioning and quality of life in adults with ASD
If the results of the current trial are positive this short-term manualised treatment using well-tested VR-software can easily be implemented in clinical practice that is in the psychiatric out-patient facilities or in community-based facilities where it can benefit a large group of suffering ASD patients Additionally it can be adapted for use in related clinical target groups such as adolescents with ASD or patients with psychosis experiencing social cognitive and functional deficits
Adults with ASD show prominent social cognitive deficits that impede their daily functioning such as being able to interact socially to achieve adequate vocational functioning ie jobeducational achievements as well as inflicting immensely on their quality of life At current no robust and replicated evidence exists on a pro-functional treatment targeting social cognitive deficits in adults with ASD
Virtual reality-based treatment offers the possibility of creating artificial experiences in real time that make the user feel immersed and able to interact as if it was the real world Additionally virtual reality therapy allows for personalization of the therapy to match the specific social challenges of each patient
Preliminary findings suggest virtual reality exposure to lead to faster symptom reduction than traditional therapy and may therefore be cost-effective While the potential beneficial effects of virtual reality exposure to challenging social situations that taps social cognitive functions are evident and virtual reality therapies are promising in general the research field is in urgent need of evidence on the effectiveness of virtual reality therapy in adults with ASD
The STEPS trial evaluates the effect of a Virtual Reality-based pro-functional Social Cognitive Training VRSCT versus treatment as usual We expect to find VRSCT to be more beneficial in improving social cognitive deficits daily life functioning and quality of life in adults with ASD
If the results of the current trial are positive this short-term manualised treatment using well-tested VR-software can easily be implemented in clinical practice that is in the psychiatric out-patient facilities or in community-based facilities where it can benefit a large group of suffering ASD patients Additionally it can be adapted for use in related clinical target groups such as adolescents with ASD or patients with psychosis experiencing social cognitive and functional deficits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None