<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/NCT03020277</url>
  </required_header>
  <id_info>
    <org_study_id>RC16_0185</org_study_id>
    <nct_id>NCT03020277</nct_id>
  </id_info>
  <brief_title>Use of a Smartphone© Application to Study Autism Spectrum Disorders (ASD)</brief_title>
  <acronym>SMARTAUTISM</acronym>
  <official_title>Use of a Smartphone© Application to Study Autism Spectrum Disorders (ASD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut de Recherche en Santé Publique, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, longitudinal, exploratory, open study with a 6-month follow-up period&#xD;
      to explore via a specific Smartphone© application the evolution of a child's behavior over 6&#xD;
      months and the (psychological and social) effects of these changes on the family.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, longitudinal, exploratory, open study with a 6-month follow-up period&#xD;
      to assess the feasibility of using a Smartphone© application designed for parents of patients&#xD;
      with ASD and to longitudinally collect data on the quality of life and anxiety of parents of&#xD;
      children with ASD and the children's functional symptoms over multiple weeks under natural&#xD;
      conditions.&#xD;
&#xD;
      Population:&#xD;
&#xD;
      The investigators propose to study individuals diagnosed with ASD based on National Health&#xD;
      Authority (HAS) recommendations (on ADI-R diagnoses) from 3-16 years of age in the Pays de la&#xD;
      Loire region. The investigators propose to include 100 families. The study is exploratory in&#xD;
      nature; thus, randomizing patients is unnecessary. The investigators will include the first&#xD;
      100 families agreeing to participate in the study and meeting the inclusion criteria. All&#xD;
      participants will be recruited from the Department of Child and Adolescent Psychiatry of&#xD;
      University Hospital of Nantes and from the Regional Center for Autism (CRA des Pays de la&#xD;
      Loire).&#xD;
&#xD;
      Method:&#xD;
&#xD;
      At the inclusion visit, parents will receive a code to download the app from the &quot;application&#xD;
      store&quot; of their choice (depending on their Smartphone©) and sign an informed consent form.&#xD;
&#xD;
      All type 1 data from the inclusion visit will be stored in an electronic database and in the&#xD;
      Smartphone© application (during the setup process).&#xD;
&#xD;
      This initial evaluation by the investigator will include the following type 1 data:&#xD;
&#xD;
        -  Sibling rank and marital status,&#xD;
&#xD;
        -  Lifestyle: rural or urban; single or multiple occupants of the chid's bedroom and&#xD;
           housing type and surface,&#xD;
&#xD;
        -  Educational and teaching load and conditions (special education, inclusive education,&#xD;
           partial or full time, etc.), and&#xD;
&#xD;
        -  The therapeutic management (speech therapy, psychomotor therapy, etc.).&#xD;
&#xD;
      Type 2 data will be stored in the electronic database only:&#xD;
&#xD;
        -  Age at diagnosis,&#xD;
&#xD;
        -  Current drug treatments (name, starting date and dose),&#xD;
&#xD;
        -  Comorbidities (associated epilepsy, mental retardation and organic pathology),&#xD;
&#xD;
        -  Medical and psychiatric family antecedent (ATCD),&#xD;
&#xD;
        -  Original scores on the Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic&#xD;
           Observation Schedule (ADOS) at the time of diagnosis, and&#xD;
&#xD;
        -  Scores on the French version of the Childhood Autism Rating Scale (CARS)&#xD;
           (http://www.autisme.qc.ca) at baseline and at the end of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Filling rate of the application</measure>
    <time_frame>6 months</time_frame>
    <description>The primary outcome measure will be the filling rate (R) and the use of our application by the parents over six months. This number will be Automatically Generated by Application (AGA)&#xD;
Number of fillings = R 60</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>child behavior with pairs</measure>
    <time_frame>every 3 days for 6 months</time_frame>
    <description>Secondary outcome measure include data from the application, that will be also Automatically Generated by the Application, which is filled by the parents, predominantly using a VAS from 0 (no) to 10 (severe) to measure the following variables</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>child sleep disorders</measure>
    <time_frame>every 3 days for 6 months</time_frame>
    <description>Secondary outcome measure include data from the application, that will be also Automatically Generated by the Application, which is filled by the parents, predominantly using a VAS from 0 (no) to 10 (severe) to measure the following variables</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>child eating disorders</measure>
    <time_frame>every 3 days for 6 months</time_frame>
    <description>Secondary outcome measure include data from the application, that will be also Automatically Generated by the Application, which is filled by the parents, predominantly using a VAS from 0 (no) to 10 (severe) to measure the following variables</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>child general behavior</measure>
    <time_frame>every 3 days for 6 months</time_frame>
    <description>Secondary outcome measure include data from the application, that will be also Automatically Generated by the Application, which is filled by the parents, predominantly using a Visual Analogic scale (VAS) from 0 (no) to 10 (severe) to measure the following variables</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogic scale quotation about parental self esteem</measure>
    <time_frame>every 3 days for 6 months</time_frame>
    <description>Visual Analogic scale (1 is bad to 10 is perfect ) quotation about parental self esteem by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogic scale quotation about parental anxiety</measure>
    <time_frame>every 3 days for 6 months</time_frame>
    <description>Visual Analogic scale (1 is bad to 10 is perfect) quotation about parental anxiety by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogic scale quotation about parental sleep</measure>
    <time_frame>every 3 days for 6 months</time_frame>
    <description>Visual Analogic scale (1 is bad to 10 is perfect) quotation about parental sleep by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogic scale quotation about parental mood</measure>
    <time_frame>every 3 days for 6 months</time_frame>
    <description>Visual Analogic scale (1 is bad to 10 is perfect) quotation about parental mood by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogic scale quotation about parental stress</measure>
    <time_frame>every 3 days for 6 months</time_frame>
    <description>Visual Analogic scale (1 is bad to 10 is perfect) quotation about parental stress by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogic scale quotation about parental pain</measure>
    <time_frame>every 3 days for 6 months</time_frame>
    <description>Visual Analogic scale (1 is bad to 10 is perfect) quotation about parental pain by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogic scale quotation about parental professional life</measure>
    <time_frame>every 3 days for 6 months</time_frame>
    <description>Visual Analogic scale (1 is unsatisfactory to 10 is satisfactory) quotation about parental professional life by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogic scale quotation about parental personal life</measure>
    <time_frame>every 3 days for 6 months</time_frame>
    <description>Visual Analogic scale (1 is unsatisfactory to 10 is satisfactory) quotation about parental personal life by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogic scale quotation about parental social life</measure>
    <time_frame>every 3 days for 6 months</time_frame>
    <description>Visual Analogic scale (1 is unsatisfactory to 10 is satisfactory) quotation about parental social life by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogic scale quotation about parental support and resources</measure>
    <time_frame>every 3 days for 6 months</time_frame>
    <description>Visual Analogic scale (1 is unsatisfactory to 10 is satisfactory) quotation about parental support and resources from third persons by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the duration of use</measure>
    <time_frame>every 3 days for 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the time of use</measure>
    <time_frame>every 3 days for 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of complete filling</measure>
    <time_frame>every 3 days for 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Autism Spectrum Disorders</condition>
  <arm_group>
    <arm_group_label>ASD children families</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ecological Momentary Assessment with Smartphone© Application</intervention_name>
    <description>Filling of the application every 3 days for 6 months by subjects (parents of patients with ASD)</description>
    <arm_group_label>ASD children families</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having a child with an ASD diagnosis based on the International Classification of&#xD;
             Diseases (ICD) 10 criteria.&#xD;
&#xD;
          -  Having at least one Smartphone© (iOS Apple or Android).&#xD;
&#xD;
          -  Signing the consent form for participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having several children with an ASD diagnosis.&#xD;
&#xD;
          -  Having children living in more than two areas&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olivier Bonnot, PU-PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nantes CHU</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Olivier Bonnot, PU-PH</last_name>
    <phone>02 53 48 26 53</phone>
    <email>olivier.bonnot@chu-nantes.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nantes CHU</name>
      <address>
        <city>France</city>
        <state>Nantes</state>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Olivier Bonnot, PU-PH</last_name>
      <phone>02 53 48 26 53</phone>
      <email>olivier.bonnot@chu-nantes.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Angers CHU</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Philippe DUVERGER, PU-PH</last_name>
      <phone>02.41.35.36.37</phone>
      <email>PhDuverger@chu-angers.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Bonnot O, Bonneau D, Doudard A, Duverger P. Rationale and protocol for using a smartphone application to study autism spectrum disorders: SMARTAUTISM. BMJ Open. 2016 Nov 22;6(11):e012135. doi: 10.1136/bmjopen-2016-012135.</citation>
    <PMID>27881525</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2017</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>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</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/NCT03020277
org study id: RC16_0185
nct id: NCT03020277
lead sponsor: 
collaborator: 
has dmc: No
This is a prospective, longitudinal, exploratory, open study with a 6-month follow-up period
      to explore via a specific Smartphone© application the evolution of a child's behavior over 6
      months and the (psychological and social) effects of these changes on the family.
This is a prospective, longitudinal, exploratory, open study with a 6-month follow-up period
      to assess the feasibility of using a Smartphone© application designed for parents of patients
      with ASD and to longitudinally collect data on the quality of life and anxiety of parents of
      children with ASD and the children's functional symptoms over multiple weeks under natural
      conditions.

      Population:

      The investigators propose to study individuals diagnosed with ASD based on National Health
      Authority (HAS) recommendations (on ADI-R diagnoses) from 3-16 years of age in the Pays de la
      Loire region. The investigators propose to include 100 families. The study is exploratory in
      nature; thus, randomizing patients is unnecessary. The investigators will include the first
      100 families agreeing to participate in the study and meeting the inclusion criteria. All
      participants will be recruited from the Department of Child and Adolescent Psychiatry of
      University Hospital of Nantes and from the Regional Center for Autism (CRA des Pays de la
      Loire).

      Method:

      At the inclusion visit, parents will receive a code to download the app from the "application
      store" of their choice (depending on their Smartphone©) and sign an informed consent form.

      All type 1 data from the inclusion visit will be stored in an electronic database and in the
      Smartphone© application (during the setup process).

      This initial evaluation by the investigator will include the following type 1 data:

        -  Sibling rank and marital status,

        -  Lifestyle: rural or urban; single or multiple occupants of the chid's bedroom and
           housing type and surface,

        -  Educational and teaching load and conditions (special education, inclusive education,
           partial or full time, etc.), and

        -  The therapeutic management (speech therapy, psychomotor therapy, etc.).

      Type 2 data will be stored in the electronic database only:

        -  Age at diagnosis,

        -  Current drug treatments (name, starting date and dose),

        -  Comorbidities (associated epilepsy, mental retardation and organic pathology),

        -  Medical and psychiatric family antecedent (ATCD),

        -  Original scores on the Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic
           Observation Schedule (ADOS) at the time of diagnosis, and

        -  Scores on the French version of the Childhood Autism Rating Scale (CARS)
           (http://www.autisme.qc.ca) at baseline and at the end of the study.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Filling rate of the application
time frame: 6 months
description: The primary outcome measure will be the filling rate (R) and the use of our application by the parents over six months. This number will be Automatically Generated by Application (AGA)
Number of fillings = R 60
measure: child behavior with pairs
time frame: every 3 days for 6 months
description: Secondary outcome measure include data from the application, that will be also Automatically Generated by the Application, which is filled by the parents, predominantly using a VAS from 0 (no) to 10 (severe) to measure the following variables
measure: child sleep disorders
time frame: every 3 days for 6 months
description: Secondary outcome measure include data from the application, that will be also Automatically Generated by the Application, which is filled by the parents, predominantly using a VAS from 0 (no) to 10 (severe) to measure the following variables
measure: child eating disorders
time frame: every 3 days for 6 months
description: Secondary outcome measure include data from the application, that will be also Automatically Generated by the Application, which is filled by the parents, predominantly using a VAS from 0 (no) to 10 (severe) to measure the following variables
measure: child general behavior
time frame: every 3 days for 6 months
description: Secondary outcome measure include data from the application, that will be also Automatically Generated by the Application, which is filled by the parents, predominantly using a Visual Analogic scale (VAS) from 0 (no) to 10 (severe) to measure the following variables
measure: Visual Analogic scale quotation about parental self esteem
time frame: every 3 days for 6 months
description: Visual Analogic scale (1 is bad to 10 is perfect ) quotation about parental self esteem by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)
measure: Visual Analogic scale quotation about parental anxiety
time frame: every 3 days for 6 months
description: Visual Analogic scale (1 is bad to 10 is perfect) quotation about parental anxiety by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)
measure: Visual Analogic scale quotation about parental sleep
time frame: every 3 days for 6 months
description: Visual Analogic scale (1 is bad to 10 is perfect) quotation about parental sleep by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)
measure: Visual Analogic scale quotation about parental mood
time frame: every 3 days for 6 months
description: Visual Analogic scale (1 is bad to 10 is perfect) quotation about parental mood by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)
measure: Visual Analogic scale quotation about parental stress
time frame: every 3 days for 6 months
description: Visual Analogic scale (1 is bad to 10 is perfect) quotation about parental stress by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)
measure: Visual Analogic scale quotation about parental pain
time frame: every 3 days for 6 months
description: Visual Analogic scale (1 is bad to 10 is perfect) quotation about parental pain by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)
measure: Visual Analogic scale quotation about parental professional life
time frame: every 3 days for 6 months
description: Visual Analogic scale (1 is unsatisfactory to 10 is satisfactory) quotation about parental professional life by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)
measure: Visual Analogic scale quotation about parental personal life
time frame: every 3 days for 6 months
description: Visual Analogic scale (1 is unsatisfactory to 10 is satisfactory) quotation about parental personal life by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)
measure: Visual Analogic scale quotation about parental social life
time frame: every 3 days for 6 months
description: Visual Analogic scale (1 is unsatisfactory to 10 is satisfactory) quotation about parental social life by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)
measure: Visual Analogic scale quotation about parental support and resources
time frame: every 3 days for 6 months
description: Visual Analogic scale (1 is unsatisfactory to 10 is satisfactory) quotation about parental support and resources from third persons by participants as assessed by SMARTAUTISM Application V1 2017 (Registered App)
measure: the duration of use
time frame: every 3 days for 6 months
measure: the time of use
time frame: every 3 days for 6 months
measure: rate of complete filling
time frame: every 3 days for 6 months
arm group label: ASD children families
arm group type: Other
intervention type: Other
intervention name: Ecological Momentary Assessment with Smartphone© Application
description: Filling of the application every 3 days for 6 months by subjects (parents of patients with ASD)
arm group label: ASD children families
criteria: 
gender: All
minimum age: 3 Years
maximum age: 16 Years
healthy volunteers: No
last name: Olivier Bonnot, PU-PH
role: Principal Investigator
affiliation: Nantes CHU
last name: Olivier Bonnot, PU-PH
phone: 02 53 48 26 53
email: olivier.bonnot@chu-nantes.fr
facility: 
contact: 
facility: 
contact: 
country: France
citation: Bonnot O, Bonneau D, Doudard A, Duverger P. Rationale and protocol for using a smartphone application to study autism spectrum disorders: SMARTAUTISM. BMJ Open. 2016 Nov 22;6(11):e012135. doi: 10.1136/bmjopen-2016-012135.
PMID: 27881525
responsible party type: Sponsor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive