{"doc_desc":{"title":"Enfants - Parents - Trouble d\u00e9ficit de l\u2019attention avec Hyperactivit\u00e9 : Impact et Evaluation","idno":"FRESH-PEF174-en","producers":[{"name":"Anne PONTHIEUX","affiliation":"NOVARTIS PHARMA SAS"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF174-en","IDno":{"metadata_no":[{"agency":"PEF","code":"174"},{"agency":"FReSH","code":"FRESH-PEF174"}]},"title":"Enfants - Parents - Trouble d\u00e9ficit de l\u2019attention avec Hyperactivit\u00e9 : Impact et Evaluation","alternate_title":"EMPATHIE"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Anne;PONTHIEUX","PILabo":"Novartis Pharma","affiliationName":"NOVARTIS PHARMA SAS","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"076037657","role":"pi id"},{"title":"SIREN","uri":"410349070","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"anne.ponthieux@novartis.com","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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","email":"anne.ponthieux@novartis.com","type":"contact","affiliationName":"NOVARTIS PHARMA SAS","contactPointLabo":"","extlink":[{"uri":"410349070","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Proximology siblings Parents"}],"topics":[{"topic":"Neurology","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":"Paediatrics","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":"Psychiatry","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":"Attention deficit hyperactivity disorder, combined presentation","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/542202013","title":"CIM-11"}]},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"}],"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":"","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Child (6 to 12 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"General population\",\n    \"level_type_clusion_other\": \"\",\n    \"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.  \",\n    \"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)\"\n}","data_kind":"['Clinical data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Quality of life\/health perception"}]},"method":{"data_collection":{"time_method":"One-time cross-sectional study","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[500-1000[ individuals","response_rate":"129"},"method_notes":"Observational Study","study_class":"Completed study","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"To be defined\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"16-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"01-12-2018","isContributorPI":"No","contributorName":"Anne PONTHIEUX","contributorAffiliation":"NOVARTIS PHARMA SAS","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industry"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"No","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"self-questionnaires filled in bye parents and siblings at home and returned by mail","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"peadiatric psychopathology department, Robert Debr\u00e9 Hospital (Paris) and pediatric neurology department, University Hospital of Amiens"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}