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Symbolic Representation in Young Children With Down Syndrome

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00668980
First received: April 25, 2008
Last updated: January 13, 2010
Last verified: January 2010
  Purpose

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.


Condition
Down Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Constitution of Symbolic Representation in Young Children With Down Syndrome

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Performance on monthly assessments administered after the initial evaluation [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: July 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study group
20 infants with Down syndrome
Control Group
15 typically developing children

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria for Study Group:

  • genetic diagnosis of Down Syndrome
  • be at the 4th stage of sensorimotor period at the initial assessment
  • good health conditions
  • good results on audiologic evaluation
  • pediatric and ear, nose and throat periodic check ups.

Inclusion Criteria for Control Group:

  • good health conditions
  • be at the 4th stage of sensorimotor period at the initial assessment
  • pediatric and ear, nose and throat periodic check ups.

Exclusion Criteria for all groups:

  • submission to long term hospitalizations due to heart diseases and major respiratory airway infections, that may interfere in the child's global development
  • presence of visual or auditory important deficits
  • historic of prematurely and/or low birth weight
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668980

Locations
Brazil
APAE Sao José dos Campos
Sao Jose Dos Campos, Sao Paulo, Brazil, 12233-400
University Hospital
Sao Paulo, São Paulo, Brazil, 05360-160
University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy
Sao Paulo, Brazil, 05360-160
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Chair: Suelly CO Limongi, PhD. University of Sao Paulo
Principal Investigator: Fabiola C Flabiano, PhD. student University of Sao Paulo
  More Information

No publications provided

Responsible Party: Suelly Cecilia Olivan Limongi, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00668980     History of Changes
Other Study ID Numbers: 06/50842-4
Study First Received: April 25, 2008
Last Updated: January 13, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Down syndrome
symbolic representation
gestures
expressive language development

Additional relevant MeSH terms:
Down Syndrome
Syndrome
Abnormalities, Multiple
Chromosome Disorders
Congenital Abnormalities
Disease
Genetic Diseases, Inborn
Intellectual Disability
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014