Tool for Evaluating the Effectiveness of the DENVER Protocol

Autism Spectrum Disorder Clinical Trial

— FACECOM  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06253793
• Other study ID #: 38RC23.0401
• Status: Not yet recruiting
• Start date: May 13, 2024
• Est. completion date: May 31, 2028

Study information

• Verified date: January 2024
• Source: University Hospital, Grenoble
• Contact: Stéphanie BIOULAC-ROGIER, Pr, MD
• Email: sbioulacrogier[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: May 31, 2028
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Locations

Country	Name	City	State
France	Savoie Hospital Center	Chambéry	Savoie
France	University Grenoble Alps	Grenoble
France	Alps-Isere Hospital Center	Saint-Égrève	Isere

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	University Grenoble Alps

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	looking time during natural social scenes	Looking time in natural interaction situations is measured by recording the direction and time of the child's gaze at faces and objects in real social scenes using a video camera. The recording is then viewed by experimenters and manually coded frame by frame (sampling frequency 25 frames/second), determining which areas of interest (face, object) are looked at by the child at each time step. This measurement is less precise than the following one, but enables us to assess these children's social skills in real scenes of adult/child interaction (PART 1 of the data collection).	measure of 10 minutes :once for the ASD control and TD control groups. Repeated 4 times (every 3 months) for the ASD Experimental group
Primary	looking time to social scenes presented on a screen	Looking time during the viewing of social scenes presented on a screen is measured using an eye-tracking system, suitable for studying populations as young as 3 months. The eye-tracker is a device used to measure very precisely (x and y spatial coordinates at a temporal sampling frequency of around 30 Hertz) where the child's gaze rests and for how long in a 2D social scene presented on screen (PART 2 of data collection). These data are collected automatically by the eye tracker (spatial coordinates at each time step) and then coded into areas of interest (gaze locations: eyes, mouth...).	measure of 10 minutes :once for the ASD control and TD control groups. Repeated 4 times (every 3 months) for the ASD Experimental group