- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05930873
Immersive Room for Visual Attention in Children With Autism Spectrum Disorders
Evaluating the Effect of Immersive Room Intervention on Visual Attention in Children With Autism Spectrum Disorders
Autism spectrum disorder (ASD) is a common neurodevelopmental disorder characterized by language delay, impaired social interactions, and repetitive behaviors. Its manifestation varies among individuals due to genetic and environmental factors. Technology-based interventions, such as robots, serious games, virtual reality and immersive room, have shown better results in the cognitive-behavioral treatment of ASD. Visual attention, which is often deficient in individuals with ASD, is a focus in these interventions, as it can aid stimulus processing. Virtual reality offers a more ecological environment for such interventions.
In this study, it has been demonstrated the effectiveness of virtual reality training by comparing the performance of an ASD group delivering treatment through the immersive room with a control group delivering traditional treatment.
Fifteen children with ASD between the ages of 5 and 10 years, with IQs between 55 and 85 will be included in the trial and, following an assessment related to visual attention processes, will be randomly assigned to the control group and the experimental group. The trial participants will, first, undergo structured sessions to foster or increase the receptive area related to the stimuli to which they will be subjected during the training.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Flavia Marino
- Phone Number: +393395798263
- Email: flavia.marino@irib.cnr.it
Study Contact Backup
- Name: Giovanni Pioggia
- Phone Number: +393203390892
- Email: giovanni.pioggia@irib.cnr.it
Study Locations
-
-
-
Messina, Italy, 98164
- Recruiting
- Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
-
Contact:
- Flavia Marino
- Email: flavia.marino@irib.cnr.it
-
Contact:
- Giovanni Pioggia
- Email: giovanni.pioggia@irib.cnr.it
-
Principal Investigator:
- Flavia Marino
-
Sub-Investigator:
- Giovanni Pioggia
-
Sub-Investigator:
- Paola Chilà
-
Sub-Investigator:
- Roberta Minutoli
-
Sub-Investigator:
- Noemi Vetrano
-
Sub-Investigator:
- Chiara Failla
-
Sub-Investigator:
- Germana Doria
-
Sub-Investigator:
- Ileana Scarcella
-
Sub-Investigator:
- Serena Previti
-
Sub-Investigator:
- Chiara Rando
-
Sub-Investigator:
- Luigi Polimeni
-
Sub-Investigator:
- Gaetano Giunta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Child with diagnosis of autism
Exclusion Criteria:
- presence of other medical disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental group
treatment within an immersive room
|
The intervention will be structured according to Applied Behavioral Analysis. A target stimulus will be presented on one of the four walls of the immersive room and a set of stimuli, including the target stimulus, which the subject will have to touch within a certain latency time. There will also be a hierarchy of prompts (least to most) in case the child gives an inaccurate answer or does not answer within the established time. Finally, as the last element of the behavioral chain, a social reinforcement will be delivered (a sound stimulus indicating applause) when the desired response is emitted. The intervention will be divided into phases, according to a progressive increase of the task in terms of visual attention, and an achievement of the acquisition criterion. Furthermore, each participant will be subjected to stimuli belonging to different semantic categories (fruit, animals, means of transport, clothing, figures and faces). |
Placebo Comparator: control group
Traditional Treatment by presenting image stimuli in a paper format
|
The intervention will be structured according to Applied Behavioral Analysis. A target stimulus will be presented in a paper format and a set of stimuli, including the target stimulus, which the subject will have to indicate within a certain latency time. There will also be a hierarchy of prompts (least to most) in case the child gives an inaccurate answer or does not answer within the established time. Finally, as the last element of the behavioral chain, a social reinforcement will be delivered (a sound stimulus indicating applause) when the desired response is emitted. The intervention will be divided into phases, according to a progressive increase of the task in terms of visual attention, and an achievement of the acquisition criterion. Furthermore, each participant will be subjected to stimuli belonging to different semantic categories (fruit, animals, means of transport, clothing, figures and faces). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wechsler Intelligence Scale for Children Fourth edition (WISC-IV)
Time Frame: The evaluation session will be scheduled pre-intervention. The test needs approximately 65-80 minutes to complete.
|
Wechsler Intelligence Scale for Children Fourth edition (WISC-IV) is a clinical tool for assessing the cognitive abilities of children and young people between the ages of 6 years and 16 years and 11 months.
|
The evaluation session will be scheduled pre-intervention. The test needs approximately 65-80 minutes to complete.
|
NEPSY-II
Time Frame: The evaluation sessions will be scheduled pre and post intervention.The test needs approximately 90 minutes to complete for preschool children and 120-180 minutes for school-age children
|
NEPSY-II is the most internationally known battery for assessing neuropsychological development in developmental age.
|
The evaluation sessions will be scheduled pre and post intervention.The test needs approximately 90 minutes to complete for preschool children and 120-180 minutes for school-age children
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Flavia Marino, Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Publications and helpful links
General Publications
- American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th ed.; American Psychiatric Publishing: Washington, DC, USA, 2013.
- Zhang M, Ding H, Naumceska M, Zhang Y. Virtual Reality Technology as an Educational and Intervention Tool for Children with Autism Spectrum Disorder: Current Perspectives and Future Directions. Behav Sci (Basel). 2022 May 10;12(5):138. doi: 10.3390/bs12050138.
- Nyaz Didehbani, Tandra Allen, Michelle Kandalaft, Daniel Krawczyk, Sandra Chapman,Virtual Reality Social Cognition Training for children with high functioning autism,Computers in Human Behavior,Volume 62, 2016,Pages 703-711
- McPartland JC, Webb SJ, Keehn B, Dawson G. Patterns of visual attention to faces and objects in autism spectrum disorder. J Autism Dev Disord. 2011 Feb;41(2):148-57. doi: 10.1007/s10803-010-1033-8.
- Jiang, M., & Zhao, Q. (2017). Learning Visual Attention to Identify People with Autism Spectrum Disorder. In Proceedings - 2017 IEEE International Conference on Computer Vision, ICCV 2017 (pp. 3287-3296)
- Burgess PW, Alderman N, Forbes C, Costello A, Coates LM, Dawson DR, Anderson ND, Gilbert SJ, Dumontheil I, Channon S. The case for the development and use of "ecologically valid" measures of executive function in experimental and clinical neuropsychology. J Int Neuropsychol Soc. 2006 Mar;12(2):194-209. doi: 10.1017/S1355617706060310.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNR-IRIB-PRO-2023-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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