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ADHD - Attention Deficit Disorder With HyperactivityNCT07426302

Virtual Reality-assisted Cognitive Rehabilitation in Autistic Youth With ADHD

A study testing VRRS Cognitive Training and Treatment as Usual (TAU) in people with ADHD - Attention Deficit Disorder With Hyperactivity and Autism Spectrum Disorder, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 8 to 18 years
What is being tested?
VRRS Cognitive Training and Treatment as Usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteItaly
Study dates
1 Jun 2023to Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site

  • Francesca Cucinotta

    Messina

Other trials in Italy

About this study

Official title: 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.

Being tested
VRRS Cognitive Training, Treatment as Usual (TAU)
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VRRS Cognitive TrainingBehavioural

    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

  • Treatment as Usual (TAU)Behavioural

    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.

Study groups in NCT07426302
Study groupRoleWhat they receive
VRRS Cognitive TrainingExperimentalThe 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.
Receives: Behavioral: VRRS Cognitive Training
Treatment As UsualActive comparatorParticipants in this group will begin traditional CBT intervention without the use of virtual reality technology.
Receives: Behavioral: Treatment as Usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Leiter-3

    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.

    Measured: T0(baseline)-T1(6months)

  2. Tower of London

    The Tower of London (ToL) is a standardized neuropsychological test used to assess higher-order executive functions, particularly planning, problem-solving, and working memory.

    Measured: T0(baseline)-T1(6months)

  3. NEPSY-II

    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.

    Measured: T0(baseline)-T1(6months)

Secondary outcomes (5)

  1. Conners Rating Scales

    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.

    Measured: T0(baseline)-T1(6months)

  2. Child Behavior Checklist (CBCL)

    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.

    Measured: T0(baseline)-T1(6months)

  3. Short Sensory Profile (SSP)

    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.

    Measured: T0(baseline)-T1(6months)

  4. Repetitive Behavior Scale-Revised (RBS-R)

    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.

    Measured: T0(baseline)-T1(6months)

  5. Quality of Life in Autism Questionnaire (QoLA)

    The Quality of Life in Autism Questionnaire (QoLA) is a validated caregiver-report instrument designed to assess autism-specific quality of life.

    Measured: T0(baseline)-T1(6months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2026
  2. Study start1 Jun 2023
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07426302
Sponsor's protocol ID
VRRS_PLUS
Status last verified
Feb 2026
First submitted
16 Feb 2026
Last updated
23 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yerys BE, Bertollo JR, Kenworthy L, Dawson G, Marco EJ, Schultz RT, Sikich L. Brief Report: Pilot Study of a Novel Interactive Digital Treatment to Improve Cognitive Control in Children with Autism Spectrum Disorder and Co-occurring ADHD Symptoms. J Autism Dev Disord. 2019 Apr;49(4):1727-1737. doi: 10.1007/s10803-018-3856-7.

    PubMed 30569407

  • Patel K, Curtis LT. A comprehensive approach to treating autism and attention-deficit hyperactivity disorder: a prepilot study. J Altern Complement Med. 2007 Dec;13(10):1091-7. doi: 10.1089/acm.2007.0611.

    PubMed 18166120

  • Chu L, Shen L, Ma C, Chen J, Tian Y, Zhang C, Gong Z, Li M, Wang C, Pan L, Zhu P, Wu D, Wang Y, Yu G. Effects of a Nonwearable Digital Therapeutic Intervention on Preschoolers With Autism Spectrum Disorder in China: Open-Label Randomized Controlled Trial. J Med Internet Res. 2023 Aug 24;25:e45836. doi: 10.2196/45836.

    PubMed 37616029

  • Chan JK, Cheung TC, Chan CW, Fang F, Lai KY, Sun X, O'Reilly H, Golan O, Allison C, Baron-Cohen S, Leung PW. Enhancing emotion recognition in young autistic children with or without attention-deficit/hyperactivity disorder in Hong Kong using a Chinese App version of The Transporters. Autism. 2024 Apr;28(4):945-958. doi: 10.1177/13623613231187176. Epub 2023 Jul 31.

    PubMed 37522637

  • De Domenico C, Alito A, Leonardi G, Pironti E, Di Cara M, Piccolo A, Settimo C, Quartarone A, Gagliano A, Cucinotta F. Children and Adolescents with Co-Occurring Attention-Deficit/Hyperactivity Disorder and Autism Spectrum Disorder: A Systematic Review of Multimodal Interventions. J Clin Med. 2025 Jun 5;14(11):4000. doi: 10.3390/jcm14114000.

    PubMed 40507763

Questions about this trial

What is this clinical trial studying?

A study testing VRRS Cognitive Training and Treatment as Usual (TAU) in people with ADHD - Attention Deficit Disorder With Hyperactivity and Autism Spectrum Disorder, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Leiter-3 (time frame: T0(baseline)-T1(6months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07426302, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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