Tool for Evaluating the Effectiveness of the DENVER Protocol

NCT ID: NCT06253793

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-13
• Study Completion Date: 2028-05-31

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.

Conditions

Autism Spectrum Disorder

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

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).

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Grenoble Alps

OTHER

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathilde FORT, PhD

Role: STUDY_CHAIR

University Grenoble Alps

Isabelle Palacios, MD

Role: STUDY_CHAIR

Alps-Isere Hospital Center

Locations

Alps-Isere Hospital Center

Saint-Égrève, Isere, France

Savoie Hospital Center

Chambéry, Savoie, France

University Grenoble Alps

Grenoble, , France

Countries

France

Central Contacts

Stéphanie BIOULAC-ROGIER, Pr, MD

Role: CONTACT

sbioulacrogier@chu-grenoble.fr

Mathilde Fort, PhD

Role: CONTACT

mathilde.fort@univ-grenoble-alpes.fr

0033688044214

Facility Contacts

Isabelle Palacios, MD

Role: primary

ipalacios@ch-alpes-isere.fr

Marine Goubier, MD

Role: primary

M.GOUBIER@chs-savoie.fr

Mathilde FORT, PhD

Role: primary

mathilde.fort@univ-grenoble-alpes.fr

Other Identifiers

38RC23.0401

Identifier Type: -

Identifier Source: org_study_id