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Идёт набор NCT06656585

Exploring Virtual Reality As an Intervention for Food Selectivity: a Clinical Trial

Без фазы С лечением Autism Autism Spectrum 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: Individual food selectivity protocol, Traditional food selectivity protocol.
Кому может быть актуально
Состояния в реестре: Autism, Autism Spectrum Disorder. Базовые параметры: 4 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluation of the Effect of a Food Selectivity Intervention Through Virtual Reality in Children with Autism Spectrum Disorders

Обзор

Food selectivity is a common challenge among children with Autism Spectrum Disorder (ASD), with significant impacts on their nutrition and well-being. The main purpose of this study is to promote children's active participation in mealtime routines and encourage experimentation with new foods through an approach that emphasizes joy and serenity during mealtimes. The study will involve children with ASD between the ages of 4 and 10 years, of both sexes. Food selectivity will be assessed through interviews with parents and the use of specially created cards. The protocol will include 45-minute sessions, twice a week, for a total of 48 sessions. The children will wear an Oculus headset and be exposed to the foods through this virtual reality tool, enhancing their engagement and willingness to try new foods in a fun and immersive way.

Вмешательства

  • Другое Individual food selectivity protocol
    Children in the experimental group wear Oculus headsets and interact with virtual foods for 20 minutes. In the "Pairing in the Kitchen" phase, Oculus is removed. Two identical plates with 6 foods are placed in front of the child. The operator, seated next to the child, interacts with the food without eating it, maintaining a positive expression, and discussing non-food topics. No prompts to eat are given, and the child can leave at any time. Progress to the next phase if the child sits calmly fo
  • Другое Traditional food selectivity protocol
    Step 1:Pairing in the Kitchen Propose enjoyable activities in the kitchen. Move to Step 2 when the child plays in the kitchen for 5 minutes over 3 consecutive sessions. Step 2:Transition to Kitchen Two plates with 6 identical foods are placed in the kitchen. The operator engages the child in a welcome game, waiting 30 seconds for spontaneous interaction. If no response, the operator prompts the child to go to the kitchen. If the child doesn't follow within 30 seconds, the session is postponed.

Первичные конечные точки

  • Brief Autism Mealtime Behavior Inventory (BAMBI) [Срок оценки: The evaluation sessions will be scheduled pre and post intervention.The test needs approximately 20 minutes to complete for parents. The tests will be scheduled pre intervention and at the study conclusion,about after 6 months.]
  • Inventory of food preferences [Срок оценки: The evaluation sessions will be scheduled pre and post intervention.The test needs approximately 20 minutes to complete for parents. The tests will be scheduled pre intervention and at the study conclusion, about after 6 months.]
  • General assessment [Срок оценки: The evaluation sessions will be scheduled pre and post intervention.The test needs approximately 15 minutes to complete for parents. The tests will be scheduled pre intervention and at the study conclusion,about after 6 months.]

Критерии участия

Критерии включения

  • Food selectivity upon parental referral
  • Child with diagnosis of autism

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

  • M. M. Essa, M. W. Qoron!eh (eds.), Personalized Food Intervention and Therapy for Autism Spectrum Disorder Management, Advances in Neurobiology 24, https://doi.org/10.1007/978-3-030-30402-7_26
  • Banire B, Khowaja K, Mansoor B, Qaraqe M, Al Thani D. Reality-Based Technologies for Children with Autism Spectrum Disorder: A Recommendation for Food Intake Intervention. Adv Neurobiol. 2020;24:679-693. doi: 10.1007/978-3-030-30402-7_26. PMID 32006380
  • Esposito M, Mirizzi P, Fadda R, Pirollo C, Ricciardi O, Mazza M, Valenti M. Food Selectivity in Children with Autism: Guidelines for Assessment and Clinical Interventions. Int J Environ Res Public Health. 2023 Mar 14;20(6):5092. doi: 10.3390/ijerph20065092. PMID 36982001
  • Peterson KM, Piazza CC, Ibanez VF, Fisher WW. Randomized controlled trial of an applied behavior analytic intervention for food selectivity in children with autism spectrum disorder. J Appl Behav Anal. 2019 Oct;52(4):895-917. doi: 10.1002/jaba.650. PMID 31642526
  • Piazza CC, Patel MR, Santana CM, Goh HL, Delia MD, Lancaster BM. An evaluation of simultaneous and sequential presentation of preferred and nonpreferred food to treat food selectivity. J Appl Behav Anal. 2002 Fall;35(3):259-70. doi: 10.1901/jaba.2002.35-259. PMID 12365739

Идентификаторы

NCT: NCT06656585 · CNR-IRIB-PRO-2024-011

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗