Tool for Evaluating the Effectiveness of the DENVER Protocol
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Autism Spectrum Disorder. Базовые параметры: 18 мес. — 5 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
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Tool for Evaluating the Effectiveness of the DENVER Protocol for Attention to Faces (Face) and the Development of Social Communication (Com) in Young Children With Autism Spectrum Disorder (ASD)
Обзор
Early remediation of the communicative and social difficulties of children with autism spectrum disorders (ASD) is central. However, from the age of 6-8 months, children with ASD show a lack of attention to social stimuli such as faces: such early avoidance behavior could be at the root of later communicative difficulties (language, attention). The Denver program aims to stimulate social communication and attention to faces in children with ASD aged between 18 and 60 months. Although the Denver protocol is currently recommended by the French National Authority for Health (HAS), the Denver protocol has not yet been widely used or evaluated in France, mainly due to a lack of tools adapted to non-verbal populations. The goal of FaceCom is to help clinicians to evaluate the efficiency of the Denver Protocol.
Подробное описание
Early remediation of the communicative and social difficulties of children with autism spectrum disorders (ASD) is central. However, from the age of 6-8 months, children with ASD show a lack of attention to social stimuli such as faces: such early avoidance behavior could be at the root of later communicative difficulties (language, attention). The Denver program aims to stimulate social communication and attention to faces in children with ASD aged between 18 and 60 months. Although the Denver protocol is currently recommended by the French National Authority for Health (HAS), the Denver protocol has not yet been widely used or evaluated in France, mainly due to a lack of tools adapted to non-verbal populations. The goal of FaceCom is to help clinicians to evaluate the efficiency of the Denver Protocol.
For children with ASD benefiting from the Denver protocol, the investigators hypothesize that an improvement in attention to social stimuli (faces, language) should be observed thanks to the Denver protocol intervention. Before the protocol, language and attention to faces of children with ASD included in the Denver protocol should resemble that of children with ASD of the same age who had not benefited from the Denver program. At the end of the Denver protocol, performance from children with ASD included in the Denver protocol should tend towards that of typically developing children of the same developmental age.
Первичные конечные точки
- looking time during natural social scenes [Срок оценки: measure of 10 minutes :once for the ASD control and TD control groups. Repeated 4 times (every 3 months) for the ASD Experimental group]
- looking time to social scenes presented on a screen [Срок оценки: measure of 10 minutes :once for the ASD control and TD control groups. Repeated 4 times (every 3 months) for the ASD Experimental group]
Критерии участия
Inclusion criteria for all groups
- native language: French
- oral consent of the child, if able to do so, written consent of 2 parents or legal guardians
Inclusion criteria for the ASD experimental and control groups:
-ASD Diagnosis The diagnosis of ASD is clinical and is made by the referring physician. It is based on the DSM 5 and the clinical assessment of each patient.
Inclusion criteria for the ASD experimental group:
- absence of neurological pathology (epilepsy, etc.) and known genetic syndrome on admission
- written consent of 2 parents or legal guardians
Non-inclusion criteria for all children:
\- primary hearing and visual impairment (unless fully corrected).
Non-inclusion criteria for DT children only:
\- a known neurodevelopmental, neurological or psychiatric disorder.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Франция · 3 центра
- Alps-Isere Hospital Center — Saint-Égrève
- Savoie Hospital Center — Chambéry
- University Grenoble Alps — Grenoble
Идентификаторы
NCT: NCT06253793 · 38RC23.0401