Down SyndromeNCT00668980
Symbolic Representation in Young Children With Down Syndrome
An observational study of Down Syndrome, run by University of Sao Paulo at 3 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- How many people
- 25 participants
- Where
- 3 sitesBrazil
- Study dates
- Jul 2006to Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
- good health conditions
- be at the 4th stage of sensorimotor period at the initial assessment
- pediatric and ear, nose and throat periodic check ups.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
APAE Sao José dos Campos
São José dos Campos, São Paulo, 12233-400
University Hospital
São Paulo, São Paulo, 05360-160
University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy
São Paulo, São Paulo, 05360-160
About this study
Official title: The Constitution of Symbolic Representation in Young Children With Down Syndrome
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.
Read the 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.
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, symbolic representation, gestures, expressive language development
- Medical subject headings
- Down Syndrome, Gestures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | 20 infants with Down syndrome | |
| Control Group | 15 typically developing children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on monthly assessments administered after the initial evaluation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startJul 2006
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Suelly CO Limongi, PhD., Study chair, University of Sao PauloFabiola C Flabiano, PhD. student, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668980
- Sponsor's protocol ID
- 06/50842-4
- Status last verified
- Jan 2010
- First submitted
- 25 Apr 2008
- Last updated
- 14 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Constitution of Symbolic Representation in Young Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT00668980
- Acronym / sponsor ID
- 06/50842-4
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, symbolic representation, gestures, expressive language development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jul 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 29 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –20 infants with Down syndrome |
| Control Group | – | –15 typically developing children |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance on monthly assessments administered after the initial evaluation
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suelly CO Limongi, PhD. study chair
University of Sao Paulo
Fabiola C Flabiano, PhD. student principal investigator
University of Sao Paulo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome, run by University of Sao Paulo at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance on monthly assessments administered after the initial evaluation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2010.