An interventional study of Experimental Group and Control Group in Autism and Autism Spectrum Disorder, sponsored by Istituto per la Ricerca e l'Innovazione Biomedica. Not yet recruiting at 1 site in Italy. Open to participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Istituto per la Ricerca e l'Innovazione Biomedica · Not applicable, Interventional, and Treatment
The Virtual Reality Rehabilitation System (VRRS) is an innovative tool for motor and cognitive rehabilitation that has shown promising results in developmental populations, with evidence of feasibility, safety, acceptability, and positive effects on attention, executive functions, and learning-related processes. Its playful and motivating features, together with the possibility of tailoring task difficulty and delivering intensive training in a controlled environment, make VRRS a promising intervention for children with autism spectrum disorder (ASD), who frequently present weaknesses in visual attention, executive functioning, and visuospatial memory.
This randomized controlled trial aims to evaluate the efficacy of a VRRS-based cognitive training program in improving visual attention, executive functions, and visuospatial memory in children with ASD, compared with an active control intervention based on conventional cognitive training. Children aged 4 to 6 years 11 months with ASD, non-verbal IQ >70, and no severe neurological or sensory comorbidities will be enrolled and randomly assigned to the experimental or control group. The intervention will consist of two 45-minute sessions per week for 12 weeks. VRRS training will include individualized tasks targeting the selected cognitive domains, with adjustable difficulty, execution time, and repetitions. Assessments will be conducted at baseline (T0) and post-intervention (T1). At baseline, non-verbal cognitive functioning will be assessed using Leiter International Performance Scale, Third Edition (LEITER-3), while attention, executive functions, and visuospatial memory will be measured using Preschool Executive Functions Assessment Battery (FE-PS), LEITER-3 attention and memory tasks, Developmental Neuropsychological Assessment - Second Edition (NEPSY-II) (Memory for Designs), and Behavior rating inventory of executive function-preschool version (BRIEF-P). The same battery will be repeated after training to compare pre- and post-intervention scores and estimate the relative efficacy of the two approaches.
It is hypothesized that children receiving VRRS-based training will show greater improvements in the targeted cognitive functions than those receiving conventional training, supporting the clinical utility of virtual reality as an effective and engaging rehabilitation approach for children with ASD.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's planned enrollment of 30 is below the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Istituto per la Ricerca e l'Innovazione Biomedica is the lead sponsor of 47 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Fifteen children with a diagnosis of autism spectrum disorder will undergo training to enhance Executive Functions, Visual Attention, Visuo-Spatial Memory through the use of the Virtual Reality Rehabilitation System (VRRS).
Device: Experimental Group
Fifteen children with a diagnosis of autism spectrum disorder will undergo traditional training to enhance Executive Functions, Visual Attention, Visuo-Spatial Memory through the use of paper-pencil tools and cognitive tasks.
Other: Control Group
During every single session, each participant will engage in the selected tasks for approximately five minutes per exercise through the use of VRRS, in order to specifically stimulate the different target cognitive functions (visual attention, executive functions, and visuo-spatial memory)
During every single session, each participant will engage in the selected tasks with objectives equivalent to those of the experimental group, but without the use of virtual reality, instead employing traditional methods and paper-and-pencil activities.
Leiter International Performance Scale, Third Edition (LEITER 3)
The LEITER-3 is a completely nonverbal test designed to measure IQ and cognitive skills, suitable for children, adolescents and adults aged 3 to 80 years. It includes ten subtests divided into two batteries: the Cognitive Battery and the Attention and Memory Battery. The Cognitive Battery asses intellectual domains, such as reasoning, visualization, and problem-solving, trough following subtests: Form Completion (FC), Classification/Analogies (CA), Sequential Order (SO), and Visual Patterns (VP). The Attention and Memory Battery evaluates attention, memory and other executive functions trough the following tasks: Sustained Attention (SA), Forward Memory (FM), Divided Attention (DA), Reverse Memory (RM), and Nonverbal Stroop (NS). Scores from the Cognitive Battery subtests are combined to provide an overall index of nonverbal intelligence, while the Attention and Memory Battery allows identification of specific cognitive strengths and weaknesses.
Time frame: The evaluation session will be scheduled at the beginning (T0) and at the end (T1) of the intervention. The test needs approximately 20-45 minutes to complete.
Preschool Executive Functions Assessment Battery (FE-PS 2-6)
The FE PS 2-6 is a tool used to assess executive functions in preschool-aged children (2-6 years). It is a battery of 10 subtests, organized into three functional areas: Inhibitory Processes, Delay of Gratification and Complex and Interdependent Abilities such as inhibition, working memory and emerging cognitive flexibility. For each subtest, z-scores and percentiles will be calculated based on the raw score.
Time frame: The evaluation session will be scheduled at the beginning (T0) and at the end (T1) of the intervention. The test needs approximately 30-45 minutes to complete.
Developmental Neuropsychological Assessment - Second Edition (NEPSY-II)
The NEPSY-II is the most internationally known battery for assessing neuropsychological development in developmental age. Only the Designed Memory subtest will be administered. This subtest assesses visuospatial learning ad memory abilities. The child is presented with a grid containing 4 to 10 designees per page, which is subsequently removed from view. The child is then required to select the corresponding designs from a set of cards and place them on the grid in the same spatial locations as previously presented. Memory for visual stimuli and memory for spatial location are scored and analyzed separately.
Time frame: The evaluation session will be scheduled at the beginning (T0) and at the end (T1) of the intervention. The test needs approximately 5-10 minutes to complete.
Behavior rating inventory of executive function-preschool version (BRIEF-P)
The BRIEF-P is a set of questionnaires for parents and teachers designed to evaluate executive function, for preschool children. It consists of 63 items that measure key domains of executive functioning: Inhibit, Shift, Emotional Control, Working Memory, and Plan/Organize. The clinical scales are aggregated into three broader indices (Inhibitory Self-Control, Flexibility, and Emergent Metacognition) and one composite score (Global Executive Composite). Additionally, The BRIEF-P includes two validity scales (Inconsistency and Negativity), to ensure the realiability of the responses.
Time frame: The evaluation sessions will be scheduled pre/post intervention (T0-T1). The test needs approximately 20 minutes to administer.
Plan to share: No
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Istituto per la Ricerca e l'Innovazione Biomedica