<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/NCT02996708</url>
  </required_header>
  <id_info>
    <org_study_id>TLM Prometted</org_study_id>
    <nct_id>NCT02996708</nct_id>
  </id_info>
  <brief_title>Assessment of the Benefit of Teleconsultations for Children With Autism Spectrum Disorders</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether Teleconsultation would a)be effective and&#xD;
      cost-effective by increasing the proportion of patients with Autism Spectrum Disorders having&#xD;
      a correct follow-up, and less transportation, and b) get a high satisfaction from the parents&#xD;
      and from the professionals&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Composite score: CARS, VABS evaluated once a year and ADI-R at least once in the lifetime</measure>
    <time_frame>One year after the start of the &quot;before&quot; period and one year after the start of the &quot;after&quot; period</time_frame>
    <description>Score equals 1 if all three evaluations are performed, 0 otherwise</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">102</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <condition>Child Autism</condition>
  <arm_group>
    <arm_group_label>Group with teleconsultation - before period</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Group without teleconsultation - before period</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Group with teleconsultation - after period</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Group without teleconsultation - after period</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Residents of medico-social structure accepting children and adolescent with autism&#xD;
        disorders&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All residents of medico-social structures accepting children and adolescent with&#xD;
             autism disorders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of parents that their child use telemedicine&#xD;
&#xD;
          -  Refusal of parents that their child participate to the research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine Doyen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Sainte Anne</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Isabelle Durand-Zaleski, MD, PhD</last_name>
    <email>isabelle.durand-zaleski@aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>IME notre Ecole</name>
      <address>
        <city>Carrieres sur Poissy</city>
        <zip>78955</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amélie Couteau</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Association Agir et Vivre l'Autisme</name>
      <address>
        <city>Chambourcy</city>
        <zip>78240</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stéphane Da</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>IME Eclair</name>
      <address>
        <city>Collegien</city>
        <zip>77090</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liora CRESPIN</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Association UNI-TEDS</name>
      <address>
        <city>Dammarie les Lys</city>
        <zip>77190</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Slimane Haddadi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Sainte Anne</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine Doyen, MD</last_name>
      <email>c.doyen@ch-sainte-anne.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>IME Le Reverdi</name>
      <address>
        <city>Vert saint denis</city>
        <zip>77240</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christine CARNIAC</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 15, 2016</last_update_submitted>
  <last_update_submitted_qc>December 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Telemedicine</keyword>
  <keyword>Health economics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02996708
org study id: TLM Prometted
nct id: NCT02996708
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether Teleconsultation would a)be effective and
      cost-effective by increasing the proportion of patients with Autism Spectrum Disorders having
      a correct follow-up, and less transportation, and b) get a high satisfaction from the parents
      and from the professionals
observational model: Cohort
time perspective: Retrospective
measure: Composite score: CARS, VABS evaluated once a year and ADI-R at least once in the lifetime
time frame: One year after the start of the "before" period and one year after the start of the "after" period
description: Score equals 1 if all three evaluations are performed, 0 otherwise
arm group label: Group with teleconsultation - before period
arm group label: Group without teleconsultation - before period
arm group label: Group with teleconsultation - after period
arm group label: Group without teleconsultation - after period
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Catherine Doyen, MD
role: Principal Investigator
affiliation: Hôpital Sainte Anne
last name: Isabelle Durand-Zaleski, MD, PhD
email: isabelle.durand-zaleski@aphp.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
sharing ipd: No