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Enrolling by Invitation

NCT Number: NCT07426302

Virtual Reality-assisted Cognitive Rehabilitation in Autistic Youth With ADHD

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.

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Key information

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Francesca Cucinotta

Messina, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VRRS Cognitive Training

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

IRCCS Centro Neurolesi Bonino Pulejo

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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