Immersive Room for Visual Attention in Children With Autism Spectrum Disorders

NCT ID: NCT05930873

Last Updated: 2023-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Autism Spectrum Disorder Autism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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experimental group

treatment within an immersive room

Group Type EXPERIMENTAL

Immersive room

Intervention Type BEHAVIORAL

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).

control group

Traditional Treatment by presenting image stimuli in a paper format

Group Type PLACEBO_COMPARATOR

stimuli in a paper format

Intervention Type BEHAVIORAL

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).

Interventions

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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).

Intervention Type BEHAVIORAL

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Child with diagnosis of autism

Exclusion Criteria

* presence of other medical disorders
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione di Comunità Messina onlus

UNKNOWN

Sponsor Role collaborator

Istituto per la Ricerca e l'Innovazione Biomedica

OTHER

Sponsor Role lead

Responsible Party

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Flavia Marino

Head of Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Flavia Marino

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Messina, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Flavia Marino

Role: CONTACT

+393395798263

Giovanni Pioggia

Role: CONTACT

+393203390892

Facility Contacts

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Flavia Marino

Role: primary

Giovanni Pioggia

Role: backup

References

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American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th ed.; American Psychiatric Publishing: Washington, DC, USA, 2013.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 35621435 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 20499148 (View on PubMed)

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)

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 16573854 (View on PubMed)

Other Identifiers

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CNR-IRIB-PRO-2023-002

Identifier Type: -

Identifier Source: org_study_id

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