Tool for Evaluating the Effectiveness of the DENVER Protocol (FACECOM)

Grenoble Alpes University Hospital Center (CHU)

Status: Not yet enrolling

Conditions: Autism Spectrum Disorder

Study type: Observational

Funder types: Other

Identifiers

NCT06253793

38RC23.0401

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 months to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

90 participants in 3 patient groups

ASD Experimental group

Description:

Children with Autism Spectrum Disorder (ASD) enrolled in the DENVER protocol. Same chronological age (1.5 years to 5 years of age) than children with ASD NOT enrolled in the DENVER protocol. Those children will be recruited and tested at the Alps-Isere Hospital Center (Saint-Egreve, France)

ASD Control group

Description:

Children with Autism Spectrum Disorder (ASD) en NOT enrolled in the DENVER protocol. Same chronological age (1.5 years to 5 years of age) than children with ASD enrolled in the DENVER protocol. Those children will be recruited and tested at the Savoie Hospital Center (Chambery, France) and at the Grenoble University Hospital (Grenoble, France).

TD control group

Description:

Typically developing (TD) children with the same developmental age than children with ASD. Those children will be recruited and tested at the University Grenoble Alps (Grenoble, France).