Generalized Training Program for Caregivers on the ESDM: PEGASE

Autism Spectrum Disorder Clinical Trial

— PEGASE  

Official title:

Generalized Training Program for Caregivers on the ESDM

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03769571
• Other study ID #: 2018-42
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2018
• Est. completion date: November 7, 2021

Study information

• Verified date: December 2018
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Clarisse Chatel, PH
• Phone: 4 91 74 57 71
• Email: clarisse.chatel[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 7, 2021
• Est. primary completion date: November 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 4 Years

Eligibility

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.

Exclusion Criteria:

• No presentation to initial and final evaluations

• Withdrawal of informed consent (which can intervene at any time of the study and without proof)

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Behavioral:
• Parental coaching program at ESDM (P-ESDM)
It will have a duration of 7 months (with an inclusion period of 1 year). Parents will come to the hospital with their child once every 15 days for one-hour parental coaching sessions on the ESDM method. Home video sessions will also be performed by parents once every 15 days. Each parent will have a Certified therapist referral to the practice of ESDM and the program is framed by a certified therapist and trained in ESDM parental coaching.

Locations

Country	Name	City	State
France	Service de pédopsychiatrie Sainte-Marguerite	Marseille	Marseille Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effectiveness of a parent's training program (name PEGASE) of young children (aged 2 to 4 years) with Autism Spectrum Disorders.	Autism Diagnostic Observation Schedule 2 (ADOS 2) : Assessment of social affect and restricted and repetitive behaviours, autism severity level/Selected module; The scale is between 0 and 3 : Note 0 is assigned when the behavior does not show abnormalities specific to the disorders invasive development; Note 1 is assigned when the behaviour is slightly abnormal or slightly unusual; Note 2 corresponds to a clearly abnormal behaviour; Note 3 is attributed to a frankly abnormal behavior, to the point that it interferes with the interaction. This note may also correspond to such a limited behaviour as the assessment of its quality social security is impossible.	7 month