Tool for Evaluating the Effectiveness of the DENVER Protocol

NCT06253793 | Not Yet Recruiting

• 1 other identifier: 38RC23.0401
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 3

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.

Conditions

Autism Spectrum Disorder

Keywords

Communication; Language; Attention; Face; Children

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

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. Those children will be recruited and tested at the Alps-Isere Hospital Center (Saint-Egreve, France)

ASD Control group

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

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).

Eligibility Criteria

• Age: 18 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• native language: French
• oral consent of the child, if able to do so, written consent of 2 parents or legal guardians
• 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.
• absence of neurological pathology (epilepsy, etc.) and known genetic syndrome on admission
• written consent of 2 parents or legal guardians
• \- primary hearing and visual impairment (unless fully corrected).
• \- a known neurodevelopmental, neurological or psychiatric disorder.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• University Grenoble Alps: collaborator

Study Sites (3)

Alps-Isere Hospital Center

Saint-Égrève, Isere, 38120, France

Location

Savoie Hospital Center

Chambéry, Savoie, 73000, France

Location

University Grenoble Alps

Grenoble, 38058, France

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Communication; Language; Facies

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mathilde FORT, PhD

  University Grenoble Alps

  STUDY CHAIR

• Isabelle Palacios, MD

  Alps-Isere Hospital Center

  STUDY CHAIR

Central Study Contacts

Stéphanie BIOULAC-ROGIER, Pr, MD

CONTACT

sbioulacrogier@chu-grenoble.fr

Mathilde Fort, PhD

CONTACT

0033688044214; mathilde.fort@univ-grenoble-alpes.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: May 13, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: May 14, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)