Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-29 @ 6:54 AM
Study NCT ID:
NCT01260792
Status:
COMPLETED
Last Update Posted:
2012-03-26
First Post:
2010-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Children and Parents With ADHD and Related Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-23', 'studyFirstSubmitDate': '2010-12-14', 'studyFirstSubmitQcDate': '2010-12-14', 'lastUpdatePostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity of studied instruments', 'timeFrame': 'at time=0', 'description': 'The only criterion of evaluation towards the type of the study and its main objective is Validity of the studied instruments'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['General Population', 'TDAH', 'Children Aged 5 to 18 Years']}, 'referencesModule': {'references': [{'pmid': '24647218', 'type': 'DERIVED', 'citation': 'Caci HM, Morin AJ, Tran A. Prevalence and correlates of attention deficit hyperactivity disorder in adults from a French community sample. J Nerv Ment Dis. 2014 Apr;202(4):324-32. doi: 10.1097/NMD.0000000000000126.'}, {'pmid': '23729493', 'type': 'DERIVED', 'citation': 'Morin AJ, Tran A, Caci H. Factorial Validity of the ADHD Adult Symptom Rating Scale in a French Community Sample: Results From the ChiP-ARD Study. J Atten Disord. 2016 Jun;20(6):530-41. doi: 10.1177/1087054713488825. Epub 2013 May 31.'}, {'pmid': '23422236', 'type': 'DERIVED', 'citation': 'Caci HM, Morin AJ, Tran A. Teacher Ratings of the ADHD-RS IV in a Community Sample: Results From the ChiP-ARD Study. J Atten Disord. 2016 May;20(5):434-44. doi: 10.1177/1087054712473834. Epub 2013 Feb 19.'}]}, 'descriptionModule': {'briefSummary': "Almost all rating scales for Attention-Deficit/Hyperactivity Disorder (ADHD) are not validated in France. This clearly hampers the development of the diagnosis and the monitoring of patients but also research in this domain. This study is conceived to collect data in the general population of children aged from 4 to 18 years in public schools in the city of Nice.\n\nChildren are pseudo-randomly selected from classes of randomly selected schools in the city of Nice (France). Teachers fill out questionnaires using a dedicated secured website, and ask parents to fill out a similar set of questionnaires regarding their child's behaviour at home. Since ADHD has a strong genetic components, parents are also asked to fill out questionnaires regarding their own behaviour at adulthood and in childhood retrospectively.\n\nAdditionally, known factors related to ADHD and other disorders as well as other putative factors are tested in the epidemiologic study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Two non-independant study groups: children aged 5 to 18, and at least one of their parents', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child known for the teacher for at least three months so that his evaluation Reflect most faithfully possible the usual behavior of the child,\n* Child having the Frenchman for mother tongue to avoid the consequences on him Behavior of a linguistic obstacle,\n* Authorization to use the data signed by at least one of the parents of the child and by the very child when he is old at least of six years.\n* Parents speaking and reading the Frenchman.\n\nExclusion Criteria:\n\n* Child known to follow a specific treatment of a disorder(confusion)attentional with / without Hyperactivity-impulsiveness (eg. Ritaline Ò, Ritaline Ò LP, Arranged Ò LP, Strattera Ò) Whatever is its duration. Indeed, a selection on this criterion would introduce a way Major which(who) would return the less reliable results(profits) of the study.\n* Child presenting a known neurological or psychiatric disorder, or a deficit Intellectual because the attentional disorders(confusions), the psychomotor excitement and The impulsiveness can be symptoms inherent to the other pathologies Neurological and\\\\or psychiatric.'}, 'identificationModule': {'nctId': 'NCT01260792', 'acronym': 'ChiP-ARD', 'briefTitle': 'Children and Parents With ADHD and Related Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Validation and Norms for Attention Deficit/Hyperactivity Disorder Scales in Children and Adults. Description of Associated Factors.', 'orgStudyIdInfo': {'id': '09-APN-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children', 'description': 'Children between 5 and 18 years old.', 'interventionNames': ['Other: questionnaire']}, {'label': 'Adults', 'description': 'Parents of children between 5 and 18 years old', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'questionnaire', 'type': 'OTHER', 'description': 'The teachers or the professors complete questionnaires on the child on their behavior in classes', 'armGroupLabels': ['Children']}, {'name': 'Questionnaire', 'type': 'OTHER', 'description': 'The parents complete a questionnaire on the behavior of their child and on their own behavior', 'armGroupLabels': ['Adults']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Hervé CACI, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nice'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}