Clinical trial NCT06253793: Tool for Evaluating the Effectiveness of the DENVER Protocol
Official title: 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)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Autism Spectrum Disorder
Keywords: Communication
Language
Attention
Face
Children
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: University Grenoble Alps
First posted: 2024-02-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ASD Experimental Group 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.

ASD Control Group Children with Autism Spectrum Disorder (ASD) NOT enrolled in the DENVER protocol.

TD Control Group Typically developing (TD) children with the same developmental age than children with ASD

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: looking time during natural social scenes
timeFrame: measure of 10 minutes :once for the ASD control and TD control groups. Repeated 4 times (every 3 months) for the ASD Experimental group
measure: looking time to social scenes presented on a screen
timeFrame: measure of 10 minutes :once for the ASD control and TD control groups. Repeated 4 times (every 3 months) for the ASD Experimental group
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Égrève
country: France
facility: Alps-Isere Hospital Center
state: Isere
city: Chambéry
country: France
facility: Savoie Hospital Center
state: Savoie
city: Grenoble
country: France
facility: University Grenoble Alps
Study officials:
affiliation: University Grenoble Alps
name: Mathilde FORT, PhD
role: STUDY_CHAIR
affiliation: Alps-Isere Hospital Center
name: Isabelle Palacios, MD
role: STUDY_CHAIR
References: