Virtual Reality-assisted Cognitive Rehabilitation in Autistic Youth With ADHD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VRRS Cognitive Training, Treatment as Usual (TAU).
- Who it may be relevant to
- Registry conditions: ADHD - Attention Deficit Disorder With Hyperactivity, Autism Spectrum Disorder. Basic parameters: 8 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Controlled Trial on the Effectiveness of Virtual Reality-assisted Executive Function Training in Autistic and ADHD Youth
Overview
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.
Interventions
- 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 - 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.
Primary outcome measures
- Leiter-3 [Time frame: T0(baseline)-T1(6months)]
- Tower of London [Time frame: T0(baseline)-T1(6months)]
- NEPSY-II [Time frame: T0(baseline)-T1(6months)]
Secondary outcome measures (5)
- Conners Rating Scales [Time frame: T0(baseline)-T1(6months)]
- Child Behavior Checklist (CBCL) [Time frame: T0(baseline)-T1(6months)]
- Short Sensory Profile (SSP) [Time frame: T0(baseline)-T1(6months)]
- Repetitive Behavior Scale-Revised (RBS-R) [Time frame: T0(baseline)-T1(6months)]
- Quality of Life in Autism Questionnaire (QoLA) [Time frame: T0(baseline)-T1(6months)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Francesca Cucinotta — Messina
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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 40507763
Identifiers
NCT: NCT07426302 · VRRS_PLUS