Clinical trial NCT05930873: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Autism
Keywords: autism
children
applied behavior analysis
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
Collaborators: name: Fondazione di Comunità Messina onlus
First posted: 2023-07-05
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Child with diagnosis of autism

Exclusion Criteria:

* presence of other medical disorders

Primary outcomes:
measure: Wechsler Intelligence Scale for Children Fourth edition (WISC-IV)
timeFrame: The evaluation session will be scheduled pre-intervention. The test needs approximately 65-80 minutes to complete.
measure: NEPSY-II
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Study officials:
affiliation: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
name: Flavia Marino
role: PRINCIPAL_INVESTIGATOR
References:
citation: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th ed.; American Psychiatric Publishing: Washington, DC, USA, 2013.
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.
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
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.
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)
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.