NCT06253793Not yet recruiting
Tool for Evaluating the Effectiveness of the DENVER Protocol
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)
Source: ClinicalTrials.gov · Last updated 14 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 90 (estimated)
- First submitted
- 2 Feb 2024
- Start date
- 13 May 2024
- Primary completion date
- 31 May 2027
- Lead sponsor
- University Hospital, Grenoble
- Diseases
- Autism
- NCT number
- NCT06253793
What you commit to
- Study type: Observational
- Planned participants: 90
- From 13 May 2024 to the primary completion date, 31 May 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
- 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.
Age in the registry: 18 months to 5 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Savoie Hospital Center Coordinator of this site? Confirm its status | Chambéry | France | Unknown status |
| University Grenoble Alps Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Alps-Isere Hospital Center Coordinator of this site? Confirm its status | Saint-Égrève | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.