Cognitive Training in Virtual Reality for Autism

June 9, 2026 updated by: Flavia Marino, Istituto per la Ricerca e l'Innovazione Biomedica

Mind in Motion: Assessing the Efficacy of Virtual Reality Cognitive Training in Neurodivergent Children With Autism

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

  • Italy
      • Messina, Italy, 98164
        • Italy Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
        • Principal Investigator:
          • Flavia Marino
        • Sub-Investigator:
          • Giovanni Pioggia
        • Sub-Investigator:
          • Chiara Failla
        • Sub-Investigator:
          • Ileana Scarcella
        • Sub-Investigator:
          • Gennaro Tartarisco
        • Sub-Investigator:
          • Roberta Bruschetta
        • Sub-Investigator:
          • Simona Campisi
        • Contact:
        • Sub-Investigator:
          • Grazia Serena Previti
        • Sub-Investigator:
          • Assunta La Corte

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

No

Description

Inclusion Criteria:

  • Diagnosis of Autism
  • QI > 70

Exclusion Criteria:

  • Severe neurological or sensory comorbidities

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 with VRRS
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
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)
Other: Control Group without VRRS
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leiter International Performance Scale, Third Edition (LEITER 3)
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.

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

Collaborators and Investigators

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

Sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Collaborators

Messina, Italy

Investigators

  • Principal Investigator: Flavia Marino, Italy 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 (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

May 20, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNR-IRIB-PRO-2026-003

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.

Clinical Trials on Autism Spectrum Disorder

Clinical Trials on Experimental Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe