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<docDscr>
  <citation>
    <titlStmt>
      <titl>Enfants - Parents - Trouble déficit de l’attention avec Hyperactivité : Impact et Evaluation</titl>
      <IDNo>FRESH-PEF174-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="NOVARTIS PHARMA SAS" role="">Anne PONTHIEUX</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Enfants - Parents - Trouble déficit de l’attention avec Hyperactivité : Impact et Evaluation            </titl>
      <altTitl>
                    EMPATHIE                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF174-en            </IDNo>
      <IDNo agency="PEF">
                    174                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF174                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Anne PONTHIEUX                                                                                </AuthEnty>
      <AuthEnty affiliation="NOVARTIS PHARMA SAS">
        <ExtLink title="SIREN" URI="410349070" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            NOVARTIS PHARMA SAS                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            NOVARTIS PHARMA SAS                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="NOVARTIS PHARMA SAS" email="anne.ponthieux@novartis.com">
                    Anne;PONTHIEUX
                                            <ExtLink title="SIREN" URI="410349070" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    Proximology siblings Parents</keyword>
      <topcClas vocab="health theme">
                        Neurology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"/>
                                                            <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D009462"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Paediatrics                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D010372"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Psychiatry                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/3de50dee-da1c-4791-a386-56bca24a5fed"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D011570"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Attention deficit hyperactivity disorder, combined presentation                                            </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">Study of the impact of the Attention-Deficit Hyperactivity Disorder (ADHD) on the parents/tutors of afflicted school children. The study also strives to evaluate the impact of the ADHD on the siblings of the children afflicted and likewise of the impact of the disease on the school environment, thanks to the evidence provided by parents/tutors.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2007-01-01"/>
      <collDate event="end" date="2008-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogCover>Hauts-de-France</geogCover>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">General population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Child (6 to 12 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D002648"/>
                                                    </universe>
      <universe clusion="I">Inclusion criteria for parents/tutors: - Parents (father, mother or tutors) of a child aged 6 to 18 years suffering from ADHD - Parents (father, mother, or tutors) accompanying their ADHD children for a routine consultation  during the observation period, - Parent (father, mother or tutor) of an child whether or not treated for his/her ADHD.  Inclusion criteria for siblings: - Brother or sister without ADHD of a child corresponding to the aforementioned criteria, - Brother or sister at least 9 years old and living with the ADHD child.                      </universe>
      <universe clusion="E"> ADHD child with important co-morbidity that could influence assessment of ADHD impact on psycho-socio-economic value, - Patients sibling / parents with important co-morbidity that could influence the evaluation of their experience (i.e. at the level of the socio-psycho-economic impact), - Parents unable to complete a self-questionnaire, - Parents who participated to the feasability study (interviews)                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Quality of life/health perception</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <timeMeth>One-time cross-sectional study</timeMeth>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[500-1000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Self-administered questionnaire                                                            <concept vocab="CESSDA" vocabURI="SelfAdministeredQuestionnaire"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <anlyInfo>
      <respRate>129</respRate>
    </anlyInfo>
    <stdyClas>Completed study</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
