Cognitive Training in Virtual Reality for Autism

NCT07643649 | Not Yet Recruiting

• 1 other identifier: CNR-IRIB-PRO-2026-003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism; Autism Spectrum Disorder

Keywords

autism; children; Virtual Reality Rehabilitation System; Cognitive Training; Executive Functions; Visual Attention; Visuo-Spatial Memory; Autism Spectrum Disorder; Autism Spectrum Condition

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  The evaluation sessions will be scheduled pre/post intervention (T0-T1). The test needs approximately 20 minutes to administer.

Study Arms (2)

Experimental Group with VRRS

EXPERIMENTAL

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

Control Group without VRRS

OTHER

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

Interventions

Experimental Group DEVICE

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)

Experimental Group with VRRS

Control Group OTHER

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.

Control Group without VRRS

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of Autism
• QI \> 70

You may not qualify if:

• Severe neurological or sensory comorbidities

Sponsors & Collaborators

• Istituto per la Ricerca e l'Innovazione Biomedica: lead
• Messina, Italy: collaborator

Study Sites (1)

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

Messina, 98164, Italy

Location

Related Publications (4)

• Cappadona I, Ielo A, La Fauci M, Tresoldi M, Settimo C, De Cola MC, Muratore R, De Domenico C, Di Cara M, Corallo F, Tripodi E, Impallomeni C, Quartarone A, Cucinotta F. Feasibility and Effectiveness of Speech Intervention Implemented with a Virtual Reality System in Children with Developmental Language Disorders: A Pilot Randomized Control Trial. Children (Basel). 2023 Aug 1;10(8):1336. doi: 10.3390/children10081336.

  PMID: 37628335 BACKGROUND

• Maggio MG, Bonanno L, Rizzo A, Barbera M, Benenati A, Impellizzeri F, Corallo F, De Luca R, Quartarone A, Calabro RS. The role of virtual reality-based cognitive training in enhancing motivation and cognitive functions in individuals with chronic stroke. Sci Rep. 2025 Jul 12;15(1):25258. doi: 10.1038/s41598-025-08173-1.

  PMID: 40652006 BACKGROUND

• Maresca G, Leonardi S, De Cola MC, Giliberto S, Di Cara M, Corallo F, Quartarone A, Pidala A. Use of Virtual Reality in Children with Dyslexia. Children (Basel). 2022 Oct 25;9(11):1621. doi: 10.3390/children9111621.

  PMID: 36360349 BACKGROUND

• Beani E, Filogna S, Martini G, Barzacchi V, Ferrari A, Guidi E, Menici V, Cioni G, Sgandurra G. Application of Virtual Reality Rehabilitation System for the assessment of postural control while standing in typical children and peers with neurodevelopmental disorders. Gait Posture. 2022 Feb;92:364-370. doi: 10.1016/j.gaitpost.2021.12.008. Epub 2021 Dec 10.

  PMID: 34923256 BACKGROUND

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Flavia Marino

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ileana Scarcella

CONTACT

3408322948; Ileana.scarcella@irib.cnr.it

Maria Valeria Maiorana

CONTACT

mariavaleria.maiorana@irib.cnr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Unit

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)