Clinical trial NCT00668980: Symbolic Representation in Young Children With Down Syndrome
Official title: The Constitution of Symbolic Representation in Young Children With Down Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Down Syndrome
Keywords: Down syndrome
symbolic representation
gestures
expressive language development
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2008-04-29
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Performance on monthly assessments administered after the initial evaluation
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Jose Dos Campos
country: Brazil
facility: APAE Sao José dos Campos
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: University Hospital
state: São Paulo
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy
Study officials:
affiliation: University of Sao Paulo
name: Suelly CO Limongi, PhD.
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Fabiola C Flabiano, PhD. student
role: PRINCIPAL_INVESTIGATOR
References: