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

May 13, 2024 updated by: University Hospital, Grenoble

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)

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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...).
measure of 10 minutes :once for the ASD control and TD control groups. Repeated 4 times (every 3 months) for the ASD Experimental group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

University Grenoble Alps

Investigators

  • Study Chair: Mathilde FORT, PhD, University Grenoble Alps
  • Study Chair: Isabelle Palacios, MD, Alps-Isere Hospital Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 13, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

February 2, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC23.0401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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