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Trial record 14 of 1519 for:    child psychiatry

Generalized Training Program for Caregivers on the ESDM: PEGASE (PEGASE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03769571
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 10, 2018
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Parental coaching program at ESDM (P-ESDM) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Generalized Training Program for Caregivers on the ESDM
Actual Study Start Date : November 8, 2018
Estimated Primary Completion Date : November 7, 2021
Estimated Study Completion Date : November 7, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
parental coaching program at ESDM (P-ESDM) 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.

No Intervention: CONTROL

Primary Outcome Measures :
  1. effectiveness of a parent's training program (name PEGASE) of young children (aged 2 to 4 years) with Autism Spectrum Disorders. [ Time Frame: 7 month ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03769571

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Contact: Clarisse Chatel, PH 4 91 74 57 71 ext + 33

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Service de pédopsychiatrie Sainte-Marguerite Recruiting
Marseille, Marseille Cedex 09, France, 13274
Contact: Clarisse Chatel, PH    0491745771   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
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Study Director: Jean Olivier Arnaud, Director Assistance Publique Hôpitaux de Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT03769571     History of Changes
Other Study ID Numbers: 2018-42
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders