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Immersive Room for Visual Attention in Children With Autism Spectrum Disorders

Primary Purpose

Autism Spectrum Disorder, Autism

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Immersive room
stimuli in a paper format
Sponsored by
Istituto per la Ricerca e l'Innovazione Biomedica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring autism, children, applied behavior analysis

Eligibility Criteria

4 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Child with diagnosis of autism Exclusion Criteria: presence of other medical disorders

Sites / Locations

  • Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

experimental group

control group

Arm Description

treatment within an immersive room

Traditional Treatment by presenting image stimuli in a paper format

Outcomes

Primary Outcome Measures

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.
NEPSY-II
NEPSY-II is the most internationally known battery for assessing neuropsychological development in developmental age.

Secondary Outcome Measures

Full Information

First Posted
June 15, 2023
Last Updated
June 29, 2023
Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Collaborators
Fondazione di Comunità Messina onlus
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1. Study Identification

Unique Protocol Identification Number
NCT05930873
Brief Title
Immersive Room for Visual Attention in Children With Autism Spectrum Disorders
Official Title
Evaluating the Effect of Immersive Room Intervention on Visual Attention in Children With Autism Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Collaborators
Fondazione di Comunità Messina onlus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Autism
Keywords
autism, children, applied behavior analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
treatment within an immersive room
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Traditional Treatment by presenting image stimuli in a paper format
Intervention Type
Behavioral
Intervention Name(s)
Immersive room
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
stimuli in a paper format
Intervention Description
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).
Primary Outcome Measure Information:
Title
Wechsler Intelligence Scale for Children Fourth edition (WISC-IV)
Description
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.
Time Frame
The evaluation session will be scheduled pre-intervention. The test needs approximately 65-80 minutes to complete.
Title
NEPSY-II
Description
NEPSY-II is the most internationally known battery for assessing neuropsychological development in developmental age.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Child with diagnosis of autism Exclusion Criteria: presence of other medical disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Flavia Marino
Phone
+393395798263
Email
flavia.marino@irib.cnr.it
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanni Pioggia
Phone
+393203390892
Email
giovanni.pioggia@irib.cnr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavia Marino
Organizational Affiliation
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
City
Messina
ZIP/Postal Code
98164
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavia Marino
Email
flavia.marino@irib.cnr.it
First Name & Middle Initial & Last Name & Degree
Giovanni Pioggia
Email
giovanni.pioggia@irib.cnr.it
First Name & Middle Initial & Last Name & Degree
Flavia Marino
First Name & Middle Initial & Last Name & Degree
Giovanni Pioggia
First Name & Middle Initial & Last Name & Degree
Paola Chilà
First Name & Middle Initial & Last Name & Degree
Roberta Minutoli
First Name & Middle Initial & Last Name & Degree
Noemi Vetrano
First Name & Middle Initial & Last Name & Degree
Chiara Failla
First Name & Middle Initial & Last Name & Degree
Germana Doria
First Name & Middle Initial & Last Name & Degree
Ileana Scarcella
First Name & Middle Initial & Last Name & Degree
Serena Previti
First Name & Middle Initial & Last Name & Degree
Chiara Rando
First Name & Middle Initial & Last Name & Degree
Luigi Polimeni
First Name & Middle Initial & Last Name & Degree
Gaetano Giunta

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th ed.; American Psychiatric Publishing: Washington, DC, USA, 2013.
Results Reference
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PubMed Identifier
35621435
Citation
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.
Results Reference
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Citation
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
Results Reference
background
PubMed Identifier
20499148
Citation
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.
Results Reference
background
Citation
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)
Results Reference
background
PubMed Identifier
16573854
Citation
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.
Results Reference
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Immersive Room for Visual Attention in Children With Autism Spectrum Disorders

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