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NCT Number: NCT06253793

Tool for Evaluating the Effectiveness of the DENVER Protocol

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.

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Key information

Age range

18 month–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alps-Isere Hospital Center, Saint-Égrève, Isere, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. looking time during natural social scenes

    Time frame: 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 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).

  2. looking time to social scenes presented on a screen

    Time frame: 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 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...).

Study contacts

Contact information is provided by the study sponsor or research team.

Mathilde Fort, PhD

CONTACT

[email protected]

0033688044214

Stéphanie BIOULAC-ROGIER, Pr, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • University Grenoble Alps

Registry information

Official study 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)

Acronym: FACECOM

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 12, 2024
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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