Immersive Room for Visual Attention in Children With Autism Spectrum Disorders

Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica (Other)
Overall Status
Recruiting
CT.gov ID
NCT05930873
Collaborator
Fondazione di Comunità Messina onlus (Other)
30
1
2
23
1.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Immersive room
  • Behavioral: stimuli in a paper format
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Evaluating the Effect of Immersive Room Intervention on Visual Attention in Children With Autism Spectrum Disorders
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: experimental group

treatment within an immersive room

Behavioral: 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

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).

Outcome Measures

Primary Outcome Measures

  1. Wechsler Intelligence Scale for Children Fourth edition (WISC-IV) [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.

  2. NEPSY-II [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Child with diagnosis of autism
Exclusion Criteria:
  • presence of other medical disorders

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) Messina Italy 98164

Sponsors and Collaborators

  • Istituto per la Ricerca e l'Innovazione Biomedica
  • Fondazione di Comunità Messina onlus

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Flavia Marino, Head of Unit, Istituto per la Ricerca e l'Innovazione Biomedica
ClinicalTrials.gov Identifier:
NCT05930873
Other Study ID Numbers:
  • CNR-IRIB-PRO-2023-002
First Posted:
Jul 5, 2023
Last Update Posted:
Jul 5, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Flavia Marino, Head of Unit, Istituto per la Ricerca e l'Innovazione Biomedica
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2023