Generalized Training Program for Caregivers on the ESDM: PEGASE (PEGASE)
Primary Purpose
Autism Spectrum Disorder
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Parental coaching program at ESDM (P-ESDM)
Sponsored by
About this trial
This is an interventional health services research trial for Autism Spectrum Disorder
Eligibility Criteria
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)
Sites / Locations
- Service de pédopsychiatrie Sainte-MargueriteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
parental coaching program at ESDM (P-ESDM)
CONTROL
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03769571
First Posted
December 6, 2018
Last Updated
December 7, 2018
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT03769571
Brief Title
Generalized Training Program for Caregivers on the ESDM: PEGASE
Acronym
PEGASE
Official Title
Generalized Training Program for Caregivers on the ESDM
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 8, 2018 (Actual)
Primary Completion Date
November 7, 2021 (Anticipated)
Study Completion Date
November 7, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
parental coaching program at ESDM (P-ESDM)
Arm Type
Other
Arm Title
CONTROL
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Parental coaching program at ESDM (P-ESDM)
Intervention Description
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.
Primary Outcome Measure Information:
Title
effectiveness of a parent's training program (name PEGASE) of young children (aged 2 to 4 years) with Autism Spectrum Disorders.
Description
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.
Time Frame
7 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clarisse Chatel, PH
Phone
4 91 74 57 71
Ext
+ 33
Email
clarisse.chatel@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Olivier Arnaud, Director
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Service de pédopsychiatrie Sainte-Marguerite
City
Marseille
State/Province
Marseille Cedex 09
ZIP/Postal Code
13274
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clarisse Chatel, PH
Phone
0491745771
Email
clarisse.chatel@ap-hm.fr
12. IPD Sharing Statement
Learn more about this trial
Generalized Training Program for Caregivers on the ESDM: PEGASE
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