Virtual Reality-assisted Cognitive Rehabilitation in Autistic Youth With ADHD

February 16, 2026 updated by: IRCCS Centro Neurolesi Bonino Pulejo

A Randomized Controlled Trial on the Effectiveness of Virtual Reality-assisted Executive Function Training in Autistic and ADHD Youth

This study aims to evaluate the effectiveness of a virtual reality-based intervention using the Virtual Reality Rehabilitation System (VRRS) to improve executive functions in autistic and ADHD youth aged 8 to 18 years. Executive functions, such as working memory, cognitive flexibility, and inhibitory control, are frequently impaired in individuals with autism and/or ADHD and significantly affect daily functioning. Participants will be randomly assigned to either an experimental group that receives VRRS-assisted cognitive training or a control group that receives treatment as usual. The intervention includes gamified tasks within immersive virtual environments specifically designed to stimulate executive skills. The primary outcome is the change in executive function scores from baseline to post-intervention, assessed using validated neuropsychological instruments. The study adopts a randomized controlled design.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Italy
      • Messina, Italy
        • Francesca Cucinotta

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 8 and 18 years at enrollment
  • Clinical diagnosis of Autism Spectrum Disorder and Attention- Deficit/Hyperactivity Disorder, based on DSM-5 criteria
  • IQ > 70
  • Signed Informed consent provided by a parent or legal guardian;
  • No acute or chronic medical conditions

Exclusion Criteria:

  • Age not between 8 and 18 years at enrollment
  • Lack of a clinical diagnosis of Autism Spectrum Disorder or Attention-Deficit/Hyperactivity Disorder
  • IQ < 70
  • Failure to sign informed consent from a parent or legal guardian;
  • Presence of acute or chronic medical conditions

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VRRS Cognitive Training
The intervention consists of 20 individual sessions using the Virtual Reality Rehabilitation System (VRRS). Each session lasts 45 minutes and is held biweekly. The project aims to stimulate and improve memory and executive functions, such as planning and attention, in children with ASD and ADHD. The VRRS platform integrates semi-immersive and interactive cognitive exercises in a virtual environment, increasing engagement and motivation. Tasks are progressively adapted to the participant's level and performance.
Behavioral: VRRS Cognitive Training
VRRS is a virtual reality system designed to offer interactive cognitive exercises in an immersive environment. Participants will complete 20 sessions (one session per week). Each session lasts approx
Active Comparator: Treatment As Usual
Participants in this group will begin traditional CBT intervention without the use of virtual reality technology.
Behavioral: Treatment as Usual (TAU)
Participants will receive the usual care typically provided in clinical or educational settings, such as attention training, memory exercises, or academic support. The frequency and duration of sessions will be comparable to the experimental group, but without the use of VR technology.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Leiter-3
Time Frame: T0(baseline)-T1(6months)
The Leiter-3 is a nonverbal, standardized cognitive assessment tool designed to evaluate intellectual functioning, attention, and memory in children and adolescents. In this study, selected subtests from the Leiter-3 will be used not only to estimate nonverbal IQ, but also to assess attentional control and memory capacity at both baseline and post-intervention. Administering the Leiter-3 at T0 and T1 allows for the comparison of pre- and post-intervention cognitive functioning without the confounding effects of language. Scaled scores from the Reasoning, Attention/Memory, and Processing Speed subdomains will be analyzed.
T0(baseline)-T1(6months)
Tower of London
Time Frame: T0(baseline)-T1(6months)
The Tower of London (ToL) is a standardized neuropsychological test used to assess higher-order executive functions, particularly planning, problem-solving, and working memory.
T0(baseline)-T1(6months)
NEPSY-II
Time Frame: T0(baseline)-T1(6months)
Subtests from the NEPSY-II (e.g., Auditory Attention and Response Set, Inhibition) will be administered to evaluate selective attention, sustained attention, cognitive flexibility, and the ability to shift between task demands. These measures are developmentally appropriate and widely used to detect attentional and executive control difficulties in children and adolescents with neurodevelopmental conditions.
T0(baseline)-T1(6months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Conners Rating Scales
Time Frame: T0(baseline)-T1(6months)
The Conners Rating Scales are validated questionnaires completed by caregivers and/or teachers to assess symptoms of inattention, hyperactivity, and impulsivity, as well as related behavioral concerns.
T0(baseline)-T1(6months)
Child Behavior Checklist (CBCL)
Time Frame: T0(baseline)-T1(6months)
The CBCL is a caregiver-completed behavioral inventory used to identify emotional and behavioral problems in children. It includes internalizing and externalizing behavior subscales and is a standardized tool for tracking psychological and behavioral changes over time in children with ASD and ADHD. T-scores will be used for analysis.
T0(baseline)-T1(6months)
Short Sensory Profile (SSP)
Time Frame: T0(baseline)-T1(6months)
The SSP is a caregiver-reported tool used to identify atypical sensory processing patterns in children. It provides scores on several sensory domains such as tactile sensitivity, sensory seeking, and auditory filtering. This instrument is widely used to describe sensory modulation issues in neurodivergent children and track potential improvements following therapeutic interventions.
T0(baseline)-T1(6months)
Repetitive Behavior Scale-Revised (RBS-R)
Time Frame: T0(baseline)-T1(6months)
The RBS-R is a caregiver-reported measure of repetitive and restricted behaviors, including stereotypies, compulsions, insistence on sameness, and ritualistic behaviors. It is frequently used in research on autism to quantify behavioral rigidity and repetitive actions. Total and subscale scores will be analyzed to determine the impact of the intervention on these behaviors.
T0(baseline)-T1(6months)
Quality of Life in Autism Questionnaire (QoLA)
Time Frame: T0(baseline)-T1(6months)
The Quality of Life in Autism Questionnaire (QoLA) is a validated caregiver-report instrument designed to assess autism-specific quality of life.
T0(baseline)-T1(6months)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Centro Neurolesi Bonino Pulejo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cucinotta Francesca, CF, IRCCS Neurolesi Bonino Pulejo

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VRRS_PLUS

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.

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