{"doc_desc":{"title":"Etude transversle \"Enfants-Parents-Trouble d\u00e9ficit de l\u2019attention avec Hyperactivit\u00e9: Impact et Evaluation\"","idno":"FRESH-PEF174-fr","producers":[{"name":"Anne PONTHIEUX","affiliation":"NOVARTIS PHARMA SAS"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF174-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"174"},{"agency":"FReSH","code":"FRESH-PEF174"}]},"title":"Etude transversle \"Enfants-Parents-Trouble d\u00e9ficit de l\u2019attention avec Hyperactivit\u00e9: Impact et Evaluation\"","alternate_title":"EMPATHIE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Anne;PONTHIEUX","firstname":"Anne","lastname":"PONTHIEUX","type":"investigator","extlink":[{"title":"SIREN","uri":"410349070","role":"organisation id"}],"email":"anne.ponthieux@novartis.com","affiliationName":"NOVARTIS PHARMA SAS","PILabo":"Novartis Pharma","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"NOVARTIS PHARMA SAS","extlink":[{"title":"SIREN","uri":"410349070","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"NOVARTIS PHARMA SAS","extlink":[{"title":"SIREN","uri":"410349070"}]}]},"distribution_statement":{"contact":[{"name":"Anne;PONTHIEUX","lastname":"PONTHIEUX","firstname":"Anne","type":"contact","email":"anne.ponthieux@novartis.com","affiliationName":"NOVARTIS PHARMA SAS","contactPointLabo":"","extlink":[{"uri":"410349070","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Proximologie"},{"keyword":"fratrie"},{"keyword":"Parents"}],"topics":[{"topic":"Neurologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009462"}]},{"topic":"P\u00e9diatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"topic":"Psychiatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3de50dee-da1c-4791-a386-56bca24a5fed"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D011570"}]},{"topic":"Trouble du d\u00e9ficit de l'attention avec hyperactivit\u00e9, pr\u00e9sentation combin\u00e9e","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/542202013","title":"CIM-11"}]},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"}],"purpose":"Eudier le retentissement du Trouble D\u00e9ficitaire de l\u2019Attention avec Hyperactivit\u00e9 (TDAH) sur les parents\/tuteurs d\u2019enfants scolaris\u00e9s atteints. L\u2019\u00e9tude s\u2019attache \u00e9galement \u00e0 \u00e9valuer le retentissement du TDAH sur la fratrie des enfants atteints et de m\u00eame le retentissement de la maladie sur le milieu scolaire, gr\u00e2ce aux t\u00e9moignages des parents\/tuteurs.","abstract":"","coll_dates":[{"start":"2007-01-01","end":"2008-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Hauts-de-France']","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Crit\u00e8res d'inclusion des parents\\\/tuteurs : - Parents (p\u00e8re m\u00e8re, ou tuteurs) d\u2019un enfant \u00e2g\u00e9 de 6 \u00e0 18 ans atteints de TDAH - Parents (p\u00e8re m\u00e8re, ou tuteurs) accompagnant un de leurs enfants atteints lors d\u2019une consultation effectu\u00e9e durant la p\u00e9riode d\u2019observation, - Parent (p\u00e8re, m\u00e8re ou tuteur) d\u2019un enfant trait\u00e9 ou non pour son TDAH.  Crit\u00e8res d'inclusion de la fratrie : - Fr\u00e8re ou s\u0153ur non atteint par le TDAH d\u2019un enfant correspondant aux crit\u00e8res sus cit\u00e9s, - Fr\u00e8re ou s\u0153ur \u00e2g\u00e9(e) d\u2019au moins 9 ans et vivant encore au domicile de l\u2019enfant atteint.  \",\n    \"clusion_E\": \"Crit\u00e8res de non-inclusion des familles : - Patients dont la co-morbidit\u00e9 repr\u00e9sente la g\u00eane principale, celle-ci pouvant avoir une incidence sur l\u2019interpr\u00e9tation de l\u2019impact psycho-socio-\u00e9conomique du TDAH du patient sur son entourage, - Patients dont l\u2019entourage souffre \u00e9galement d\u2019une pathologie interf\u00e9rant dans l\u2019\u00e9valuation de son v\u00e9cu (ie au niveau du retentissement socio-psycho-\u00e9conomique), - Parents\\\/ entourages inaptes \u00e0 compl\u00e9ter un auto-questionnaire, - Parents ayant particip\u00e9 \u00e0 la phase pr\u00e9paratoire de l\u2019\u00e9tude (entretiens)\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Qualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"Etude transversale non r\u00e9p\u00e9t\u00e9e","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"129"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"16-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"01-12-2018","isContributorPI":false,"contributorName":"Anne PONTHIEUX","contributorAffiliation":"NOVARTIS PHARMA SAS","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"auto-questionnaires compl\u00e9t\u00e9s par les parents et la fratrie \u00e0 leur domicile et renvoy\u00e9s par voie postale","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"service de psychopathologie de l\u2019enfant et de l\u2019adolescent de l\u2019h\u00f4pital Robert Debr\u00e9 (Paris) et service de neurologie p\u00e9diatrique du CHU d\u2019Amiens"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}