Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder
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| First Received Date ICMJE | December 28, 2007 | ||||
| Last Updated Date | April 22, 2013 | ||||
| Start Date ICMJE | March 2003 | ||||
| Estimated Primary Completion Date | December 2020 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00592436 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 | Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder | ||||
| Official Title ICMJE | A Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder | ||||
| Brief Summary | The objective of this protocol is to establish a comprehensive screening process to evaluate the eligibility of potential pediatric subjects for appropriate ADHD clinical research studies. |
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| Detailed Description | The ADHD Clinical Research Program at Massachusetts General Hospital currently offers a range of protocols addressing different aspects of ADHD in children and adolescents. Although these protocols have received prior IRB approval, potential participants present with a widely varied set of complaints not always discernable in a telephone screening interview. This state of affairs often makes it difficult to ask subjects and their parents to sign a specific protocol's consent form without obtaining additional clinical information. Because of this, we are proposing that potential subjects and their parents undergo an in-depth clinical assessment that will allow them to be screened by a clinician for eligibility to a diverse clinical research program. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Children with symptoms of ADHD |
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| Condition ICMJE | Pediatric ADHD | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 1 | ||||
| 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 750 | ||||
| Estimated Completion Date | December 2020 | ||||
| Estimated Primary Completion Date | December 2020 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Years to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00592436 | ||||
| Other Study ID Numbers ICMJE | 2003-P-000239 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Joseph Biederman, MD, Massachusetts General Hospital | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | April 2013 | ||||
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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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