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Идёт набор NCT07367256

Using Virtual Reality to Improve Emotion Understanding in Children With Autism

Без фазы С лечением Autism Autism Disorder

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: Oculus intervention, Traditional intervention.
Кому может быть актуально
Состояния в реестре: Autism, Autism Disorder. Базовые параметры: 7 лет — 10 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
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Официальное название

Efficacy of a Virtual Reality-Mediated Intervention on Emotion Recognition and Understanding in Children With Autism Spectrum Disorder

Обзор

Autism Spectrum Disorders (ASD) are neurodevelopmental conditions characterized by difficulties in social interaction, communication, and in understanding one's own and others' mental and emotional states. In particular, skills related to the recognition, understanding, and regulation of emotions represent a significant area of vulnerability in children with high-functioning ASD, with important consequences for social and relational functioning. The present study aims to evaluate the effectiveness of an intervention protocol designed to enhance socio-emotional understanding, with a specific focus on the recognition of basic and complex emotions, the expansion of emotional vocabulary, the association between situations, thoughts, and emotions, and the differentiation between thoughts and emotions. Furthermore, the study seeks to investigate the role of immersive technology (Oculus) as a potential facilitator of emotional learning compared to a traditional intervention approach. The sample will consist of children with a diagnosis of high-functioning ASD, aged between 7 and 10 years, with sentence-level language abilities, the capacity to narrate non-present events, and an intellectual quotient above 80 (assessed using the Griffiths Scales or the WISC-IV). Participants will be divided into two groups: an experimental group (OCULUS), which will receive the intervention mediated by the use of Oculus technology, and a control group which will undergo the same protocol without technological support.

Вмешательства

  • Другое Oculus intervention
    Phase 1: Basic Emotions (happiness, sadness, anger, fear, disgust, surprise) * Step 1-3: Sequential recognition and identification of emotions on faces, using sets of 4 or 6 images. * Step 4-6: Association of thoughts, emotions, and situations in everyday scenarios. All activities are conducted through immersive virtual reality (Oculus), allowing children to interact with structured environments and scenarios that facilitate socio-emotional learning. Phase 2: Complex Emotions (guilt, shame, p
  • Другое Traditional intervention
    Phase 1: Basic Emotions (happiness, sadness, anger, fear, disgust, surprise) * Step 1-3: Sequential recognition and identification of emotions on faces, using sets of 4 or 6 images. * Step 4-6: Association of thoughts, emotions, and situations in everyday scenarios. All activities are conducted in a traditional format, without the use of immersive technology, with the therapist guiding the child directly through the exercises to support socio-emotional learning. Phase 2: Complex Emotions (gui

Первичные конечные точки

  • Test of Emotional Vocabulary (TLE) [Срок оценки: The administration has a duration of 15 minutes.]

Критерии участия

Критерии включения

  • Language in sentences
  • Ability to narrate events not present
  • QS/QI>80

Критерии исключения

  • presence of other medical disorders

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
  • Istituto per la Ricerca e l'Innovazione Biomedica — Messina

Публикации

  • Papoutsi, C., Drigas, A., & Skianis, C. (2021). Virtual and augmented reality for developing emotional intelligence skills. Int. J. Recent Contrib. Eng. Sci. IT (IJES), 9(3), 35-53.
  • Frolli A, Savarese G, Di Carmine F, Bosco A, Saviano E, Rega A, Carotenuto M, Ricci MC. Children on the Autism Spectrum and the Use of Virtual Reality for Supporting Social Skills. Children (Basel). 2022 Feb 1;9(2):181. doi: 10.3390/children9020181. PMID 35204903
  • American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.) https://doi.org/10.1176/appi.books.9780890425596.

Идентификаторы

NCT: NCT07367256 · CNR-IRIB-PRO-2026-002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗