Informations générales (source: ClinicalTrials.gov)
Generalized Training Program for Caregivers on the ESDM (PEGASE)
Interventional
N/A
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
novembre 2018
novembre 2021
29 juin 2024
The main objective of the study is to evaluate the effectiveness of a parent's training
program (name PEGASE) of young children (aged 2 to 4 years) with Autism Spectrum
Disorders.
This study is follow up by the Autism Resource Center PACA (CRA PACA), which is located
in Marseille's university Department of Child Psychiatry.
This center is a regional expert center in diagnostic and research missions in the field
of Autism. The center is promoting new advances in the field of Autism Spectrum Disorders
(ASD) The center receives requests for diagnostic assessment from all the region. Autism
is to date a major public health problem, current prevalence rates are 1 child / 88 in
the United States. This prevalence continues to increase.
Autism is a severe neurodevelopment disorder with significant functional impact.
An essential axis in the field of health is to develop new treatment strategy including
low costs and family impact particularly in quality of life.
In France, consensus guidelines (HAS 2012) on the diagnosis assessment for Autism
Spectrum Disorders (ASD) people and interventions were edited.
Support for grade recommendations have been issued. In this research, the investigators
focus on a global, early and coordinated management method: the Early Start Denver Model.
This intervention obtained a grade B to the recommendations of the HAS in 2012. Early
Start Denver Model (ESDM) is scientifically proven by a lots of studies.
Two management modalities are discuss in the ESDM model: the classical ESDM and the ESDM
P (parents ESDM). Even if in both ways of care, the parent is put in a central position
around the care of the child. In P ESDM, the parent is trained in the techniques of ESDM
itself. This parental coaching program at ESDM (P-ESDM) was developed by Rogers et al at
Sacramento Davis University.
P ESDM is not yet developed in France and has not been the subject of any French-language
publication to date.
This program is dedicated to young parents of children with autism spectrum disorders
aged between 2 and 4 years old.
This is a 7-month program (with a duration of inclusion of 3 year). The program is based
on ESDM techniques, it meets both the need to include parents in care and the idea of
reducing the cost of these care (need fewer hours of care by professionals).
This program is offered to all parents of autism spectrum disorders children between the
ages of 2 and 4 who go to CRA PACA for an expert diagnostic evaluation.
The aim of this study is to objectify the effectiveness of this parental intervention in
a French population.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Service de pédopsychiatrie Sainte-Marguerite - 13274 - Marseille - Marseille Cedex 09 - France | Clarisse Chatel, PH | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Children aged 2 to 4 years
- Child diagnosed with the clinical criteria of The Diagnostic and Statistical Manual
of Mental Disorders (DSM-5) and International Classification of Diseases 10th
Revision (ICD 10). Initial diagnosis of Autism spectrum disorder (ASD) should be
validated by recommended diagnostic scales: ADI R, ADOS 2.
- A child whose parents or legal representatives have accepted their child's
participation in this study, and have signed informed consent.
- Children aged 2 to 4 years
- Child diagnosed with the clinical criteria of The Diagnostic and Statistical Manual
of Mental Disorders (DSM-5) and International Classification of Diseases 10th
Revision (ICD 10). Initial diagnosis of Autism spectrum disorder (ASD) should be
validated by recommended diagnostic scales: ADI R, ADOS 2.
- A child whose parents or legal representatives have accepted their child's
participation in this study, and have signed informed consent.
- No presentation to initial and final evaluations
- Withdrawal of informed consent (which can intervene at any time of the study and
without proof)