Children and Parents With ADHD and Related Disorders (ChiP-ARD)
| Tracking Information | |||||
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| First Received Date ICMJE | December 14, 2010 | ||||
| Last Updated Date | March 23, 2012 | ||||
| Start Date ICMJE | February 2010 | ||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Validity of studied instruments [ Time Frame: at time=0 ] [ Designated as safety issue: No ] The only criterion of evaluation towards the type of the study and its main objective is Validity of the studied instruments |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01260792 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Children and Parents With ADHD and Related Disorders | ||||
| Official Title ICMJE | Validation and Norms for Attention Deficit/Hyperactivity Disorder Scales in Children and Adults. Description of Associated Factors. | ||||
| Brief Summary | 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. Children 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. Additionally, known factors related to ADHD and other disorders as well as other putative factors are tested in the epidemiologic study. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Two non-independant study groups: children aged 5 to 18, and at least one of their parents |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 2600 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 5 Years to 18 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01260792 | ||||
| Other Study ID Numbers ICMJE | 09-APN-02 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Centre Hospitalier Universitaire de Nice | ||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Nice | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Universitaire de Nice | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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