Symbolic Representation in Young Children With Down Syndrome
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 25, 2008 | ||||||||
| Last Updated Date | January 13, 2010 | ||||||||
| Start Date ICMJE | July 2006 | ||||||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Performance on monthly assessments administered after the initial evaluation [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Performance on monthly assessments administered after the initial evaluation [ Time Frame: 10 months ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT00668980 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE |
Performance on a initial and final assessments, after 10 months of speech-language therapy for SG and CG1. [ Time Frame: 10 months ] [ Designated as safety issue: No ] | ||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Symbolic Representation in Young Children With Down Syndrome | ||||||||
| Official Title ICMJE | The Constitution of Symbolic Representation in Young Children With Down Syndrome | ||||||||
| Brief Summary | The aim of this study is to characterize the process of constitution of symbolic representation in infants with Down syndrome, as well as to investigate the relationship between gestures and the emergence of oral language. The investigators hypothesis is that children with Down syndrome could present difficulties during the constitution of symbolic representation that may be related to later deficits on expressive language, generally observed in these children. |
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| Detailed Description | According to the Genetic Epistemology, language development is directly related to cognitive construction. Such relationship is clearly observed after the constitution of representation that allows one individual to express his or her thinking through language. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Biospecimen | |||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Study Group - children with Down syndrome that attend speech-language therapy at the Speech Language Pathology Laboratory in Syndromes and Sensorimotor Deficits of the School of Medicine of the University of São Paulo or from the Association of Parents and Friends of Exceptional children of São José dos Campos. Control Group - typically developing children followed up in the Pediatrics Ambulatory of the University's Hospital and/or being assisted in the University' Hospital Nursery School. |
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| Condition ICMJE | Down Syndrome | ||||||||
| Intervention ICMJE | |||||||||
| Study Group/Cohort (s) |
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| Publications * | |||||||||
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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 | 25 | ||||||||
| Completion Date | April 2009 | ||||||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria for Study Group:
Inclusion Criteria for Control Group:
Exclusion Criteria for all groups:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Brazil | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00668980 | ||||||||
| Other Study ID Numbers ICMJE | 06/50842-4 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Suelly Cecilia Olivan Limongi, University of Sao Paulo | ||||||||
| Study Sponsor ICMJE | University of Sao Paulo | ||||||||
| Collaborators ICMJE | Fundação de Amparo à Pesquisa do Estado de São Paulo | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Sao Paulo | ||||||||
| Verification Date | January 2010 | ||||||||
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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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