Virtual Reality-assisted Cognitive Rehabilitation in Autistic Youth With ADHD
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: VRRS Cognitive Training, Treatment as Usual (TAU).
- Кому может быть актуально
- Состояния в реестре: ADHD - Attention Deficit Disorder With Hyperactivity, Autism Spectrum Disorder. Базовые параметры: 8 лет — 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Randomized Controlled Trial on the Effectiveness of Virtual Reality-assisted Executive Function Training in Autistic and ADHD Youth
Обзор
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.
Вмешательства
- Поведенческое 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 - Поведенческое 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.
Первичные конечные точки
- Leiter-3 [Срок оценки: T0(baseline)-T1(6months)]
- Tower of London [Срок оценки: T0(baseline)-T1(6months)]
- NEPSY-II [Срок оценки: T0(baseline)-T1(6months)]
Вторичные конечные точки (5)
- Conners Rating Scales [Срок оценки: T0(baseline)-T1(6months)]
- Child Behavior Checklist (CBCL) [Срок оценки: T0(baseline)-T1(6months)]
- Short Sensory Profile (SSP) [Срок оценки: T0(baseline)-T1(6months)]
- Repetitive Behavior Scale-Revised (RBS-R) [Срок оценки: T0(baseline)-T1(6months)]
- Quality of Life in Autism Questionnaire (QoLA) [Срок оценки: T0(baseline)-T1(6months)]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Италия · 1 центр
- Francesca Cucinotta — Messina
Публикации
- 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
Идентификаторы
NCT: NCT07426302 · VRRS_PLUS