Immersive Room for Visual Attention in Children With Autism Spectrum Disorders

June 29, 2023 updated by: Flavia Marino, Istituto per la Ricerca e l'Innovazione Biomedica

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

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Messina, Italy, 98164
        • Recruiting
        • Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
        • Contact:
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Child with diagnosis of autism

Exclusion Criteria:

  • presence of other medical disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Flavia Marino, Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

June 15, 2023

First Submitted That Met QC Criteria

June 29, 2023

First Posted (Actual)

July 5, 2023

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

June 29, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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