<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03769571</url>
  </required_header>
  <id_info>
    <org_study_id>2018-42</org_study_id>
    <nct_id>NCT03769571</nct_id>
  </id_info>
  <brief_title>Generalized Training Program for Caregivers on the ESDM: PEGASE</brief_title>
  <acronym>PEGASE</acronym>
  <official_title>Generalized Training Program for Caregivers on the ESDM</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of the study is to evaluate the effectiveness of a parent's training&#xD;
      program (name PEGASE) of young children (aged 2 to 4 years) with Autism Spectrum Disorders.&#xD;
&#xD;
      This study is follow up by the Autism Resource Center PACA (CRA PACA), which is located in&#xD;
      Marseille's university Department of Child Psychiatry.&#xD;
&#xD;
      This center is a regional expert center in diagnostic and research missions in the field of&#xD;
      Autism. The center is promoting new advances in the field of Autism Spectrum Disorders (ASD)&#xD;
      The center receives requests for diagnostic assessment from all the region. Autism is to date&#xD;
      a major public health problem, current prevalence rates are 1 child / 88 in the United&#xD;
      States. This prevalence continues to increase.&#xD;
&#xD;
      Autism is a severe neurodevelopment disorder with significant functional impact.&#xD;
&#xD;
      An essential axis in the field of health is to develop new treatment strategy including low&#xD;
      costs and family impact particularly in quality of life.&#xD;
&#xD;
      In France, consensus guidelines (HAS 2012) on the diagnosis assessment for Autism Spectrum&#xD;
      Disorders (ASD) people and interventions were edited.&#xD;
&#xD;
      Support for grade recommendations have been issued. In this research, the investigators focus&#xD;
      on a global, early and coordinated management method: the Early Start Denver Model. This&#xD;
      intervention obtained a grade B to the recommendations of the HAS in 2012. Early Start Denver&#xD;
      Model (ESDM) is scientifically proven by a lots of studies.&#xD;
&#xD;
      Two management modalities are discuss in the ESDM model: the classical ESDM and the ESDM P&#xD;
      (parents ESDM). Even if in both ways of care, the parent is put in a central position around&#xD;
      the care of the child. In P ESDM, the parent is trained in the techniques of ESDM itself.&#xD;
      This parental coaching program at ESDM (P-ESDM) was developed by Rogers et al at Sacramento&#xD;
      Davis University.&#xD;
&#xD;
      P ESDM is not yet developed in France and has not been the subject of any French-language&#xD;
      publication to date.&#xD;
&#xD;
      This program is dedicated to young parents of children with autism spectrum disorders aged&#xD;
      between 2 and 4 years old.&#xD;
&#xD;
      This is a 7-month program (with a duration of inclusion of 3 year). The program is based on&#xD;
      ESDM techniques, it meets both the need to include parents in care and the idea of reducing&#xD;
      the cost of these care (need fewer hours of care by professionals).&#xD;
&#xD;
      This program is offered to all parents of autism spectrum disorders children between the ages&#xD;
      of 2 and 4 who go to CRA PACA for an expert diagnostic evaluation.&#xD;
&#xD;
      The aim of this study is to objectify the effectiveness of this parental intervention in a&#xD;
      French population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 8, 2018</start_date>
  <completion_date type="Anticipated">November 7, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 7, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>effectiveness of a parent's training program (name PEGASE) of young children (aged 2 to 4 years) with Autism Spectrum Disorders.</measure>
    <time_frame>7 month</time_frame>
    <description>Autism Diagnostic Observation Schedule 2 (ADOS 2) : Assessment of social affect and restricted and repetitive behaviours, autism severity level/Selected module&#xD;
The scale is between 0 and 3 :&#xD;
Note 0 is assigned when the behavior does not show abnormalities specific to the disorders invasive development;&#xD;
Note 1 is assigned when the behaviour is slightly abnormal or slightly unusual;&#xD;
Note 2 corresponds to a clearly abnormal behaviour;&#xD;
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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>parental coaching program at ESDM (P-ESDM)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROL</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parental coaching program at ESDM (P-ESDM)</intervention_name>
    <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.</description>
    <arm_group_label>parental coaching program at ESDM (P-ESDM)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 2 to 4 years&#xD;
&#xD;
          -  Child diagnosed with the clinical criteria of The Diagnostic and Statistical Manual of&#xD;
             Mental Disorders (DSM-5) and International Classification of Diseases 10th Revision&#xD;
             (ICD 10). Initial diagnosis of Autism spectrum disorder (ASD) should be validated by&#xD;
             recommended diagnostic scales: ADI R, ADOS 2.&#xD;
&#xD;
          -  A child whose parents or legal representatives have accepted their child's&#xD;
             participation in this study, and have signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No presentation to initial and final evaluations&#xD;
&#xD;
          -  Withdrawal of informed consent (which can intervene at any time of the study and&#xD;
             without proof)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>4 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean Olivier Arnaud, Director</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hôpitaux de Marseille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Clarisse Chatel, PH</last_name>
    <phone>4 91 74 57 71</phone>
    <phone_ext>+ 33</phone_ext>
    <email>clarisse.chatel@ap-hm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Service de pédopsychiatrie Sainte-Marguerite</name>
      <address>
        <city>Marseille</city>
        <state>Marseille Cedex 09</state>
        <zip>13274</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clarisse Chatel, PH</last_name>
      <phone>0491745771</phone>
      <email>clarisse.chatel@ap-hm.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 7, 2018</last_update_submitted>
  <last_update_submitted_qc>December 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autism Spectrum Disorder</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03769571
org study id: 2018-42
nct id: NCT03769571
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: 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
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.
arm group label: parental coaching program at ESDM (P-ESDM)
arm group type: Other
arm group label: CONTROL
arm group type: No Intervention
intervention type: Behavioral
intervention name: Parental coaching program at ESDM (P-ESDM)
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.
arm group label: parental coaching program at ESDM (P-ESDM)
criteria: 
gender: All
minimum age: 2 Years
maximum age: 4 Years
healthy volunteers: No
last name: Jean Olivier Arnaud, Director
role: Study Director
affiliation: Assistance Publique Hôpitaux de Marseille
last name: Clarisse Chatel, PH
phone: 4 91 74 57 71
phone ext: + 33
email: clarisse.chatel@ap-hm.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Autism Spectrum Disorder