Virtual Reality-assisted Cognitive Rehabilitation in Autistic Youth With ADHD

NCT07426302 | Enrolling By Invitation

• 1 other identifier: VRRS_PLUS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (3)

• 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.

  T0(baseline)-T1(6months)

• 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.

  T0(baseline)-T1(6months)

• 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.

  T0(baseline)-T1(6months)

Secondary Outcomes (5)

• Conners Rating Scales

  T0(baseline)-T1(6months)

• Child Behavior Checklist (CBCL)

  T0(baseline)-T1(6months)

• Short Sensory Profile (SSP)

  T0(baseline)-T1(6months)

• Repetitive Behavior Scale-Revised (RBS-R)

  T0(baseline)-T1(6months)

• Quality of Life in Autism Questionnaire (QoLA)

  T0(baseline)-T1(6months)

Study Arms (2)

VRRS Cognitive Training

EXPERIMENTAL

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

Treatment As Usual

ACTIVE COMPARATOR

Participants in this group will begin traditional CBT intervention without the use of virtual reality technology.

Behavioral: Treatment as Usual (TAU)

Interventions

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

VRRS Cognitive Training

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.

Treatment As Usual

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

Francesca Cucinotta

Messina, Italy

Location

Related Publications (5)

• 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.

  PMID: 30569407 BACKGROUND

• 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.

  PMID: 18166120 BACKGROUND

• 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.

  PMID: 37616029 BACKGROUND

• 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.

  PMID: 37522637 BACKGROUND

• 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.

  PMID: 40507763 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Child Development Disorders, Pervasive

Study Officials

• Cucinotta Francesca, CF

  IRCCS Neurolesi Bonino Pulejo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: June 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

IT (1)