Autism Spectrum DisorderNCT05930873
Immersive Room for Visual Attention in Children With Autism Spectrum Disorders
A study testing Immersive room and stimuli in a paper format in people with Autism Spectrum Disorder and Autism, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Autism
- What is being tested?
- Immersive room and stimuli in a paper format
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child with diagnosis of autism
Who cannot join
- presence of other medical disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Messina, 98164
Flavia Marino, flavia.marino@irib.cnr.it
Giovanni Pioggia, giovanni.pioggia@irib.cnr.it
About this study
Official title: 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.
- Conditions
- Autism Spectrum Disorder, Autism
- Being tested
- Immersive room, stimuli in a paper format
- Keywords
- autism, children, applied behavior analysis
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive roomBehavioural
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).
stimuli in a paper formatBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | treatment within an immersive room Receives: Behavioral: Immersive room |
| control group | Placebo comparator | Traditional Treatment by presenting image stimuli in a paper format Receives: Behavioral: stimuli in a paper format |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wechsler Intelligence Scale for Children Fourth edition (WISC-IV)
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.
Measured: The evaluation session will be scheduled pre-intervention. The test needs approximately 65-80 minutes to complete.
NEPSY-II
NEPSY-II is the most internationally known battery for assessing neuropsychological development in developmental age.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Jun 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione di Comunità Messina onlus
- Responsible party
- Principal investigator, Flavia Marino, Istituto per la Ricerca e l'Innovazione Biomedica
- Investigators
- Flavia Marino, Principal investigator, Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930873
- Sponsor's protocol ID
- CNR-IRIB-PRO-2023-002
- Status last verified
- Jun 2023
- First submitted
- 15 Jun 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35621435Nyaz 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.
PubMed 20499148Jiang, 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.
PubMed 16573854
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Immersive Room Intervention on Visual Attention in Children With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT05930873
- Acronym / sponsor ID
- CNR-IRIB-PRO-2023-002
- Conditions
- Autism Spectrum Disorder, Autism
- Keywords
- autism, children, applied behavior analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Collaborators
- Fondazione di Comunità Messina onlus
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: Immersive roomtreatment within an immersive room |
| control group | Placebo comparator | Behavioral: stimuli in a paper formatTraditional Treatment by presenting image stimuli in a paper format |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child with diagnosis of autism
Key exclusion criteria (1 listed)
- presence of other medical disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive roomThe 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). | Behavioural | experimental group |
| stimuli in a paper formatThe 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). | Behavioural | control group |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- BackgroundAmerican Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th ed.; American Psychiatric Publishing: Washington, DC, USA, 2013.
- Background: PubMed 35621435Zhang 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.
- BackgroundNyaz 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
- Background: PubMed 20499148McPartland 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.
- BackgroundJiang, 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)
- Background: PubMed 16573854Burgess 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flavia Marino principal investigator
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive room and stimuli in a paper format in people with Autism Spectrum Disorder and Autism, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Flavia Marino (+393395798263, flavia.marino@irib.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05930873, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.