Down SyndromeNCT00844259
Functional Communicative Profile of Children With Down Syndrome
An observational study of Down Syndrome, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The aim of this study was to verify the use of communicative functions by children with DS in two interaction conditions: interaction with therapist and interaction with parent. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2006to Oct 2007
- 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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 15 children with Down syndrome aged from 5 to 8 years.
Who may be able to join
- genetic diagnosis of Down syndrome
- good health conditions
- normal results on audiologic evaluation
- pediatric and ear, nose and throat periodic check ups.
- attend speech-language therapy at the Speech Language Pathology Laboratory in Syndromes and Sensorimotor Deficits (SLPL-SSD) of the School of Medicine of the University of São Paulo.
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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
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
The aim of this study was to verify the use of communicative functions by children with DS in two interaction conditions: interaction with therapist and interaction with parent.
Read the detailed description
Parents and caregivers' engagement on therapeutic process of children with Down syndrome (DS) is important for language and communication development. The identification of the communicative skills presented by these children as well as the context influence in their performance as interlocutors, will contribute to the design of therapeutic interventions.
Pragmatics theories are helpful to language use studies, since it takes into account social and environmental aspects and considers adult-child interaction as a determinant factor for its occurrence.
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, Pragmatics, Language Development
- Medical subject headings
- Down Syndrome
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 |
|---|---|---|
| Research Group | 15 children with Down syndrome, observed in two interaction conditions: playing with their therapist (A) and playing with their caregiver (B). |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startJul 2006
- Primary completionOct 2007
- Study completionOct 2007
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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Suelly CO Limongi, PhD, Study chair, University of Sao PauloEliza P Cunha, Ms student, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844259
- Sponsor's protocol ID
- 180875
- Status last verified
- Feb 2009
- First submitted
- 13 Feb 2009
- Last updated
- 16 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Communicative Profile of Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT00844259
- Acronym / sponsor ID
- 180875
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, Pragmatics, Language Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 16 Feb 2009 (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 was to verify the use of communicative functions by children with DS in two interaction conditions: interaction with therapist and interaction with parent.
Detailed description
Parents and caregivers' engagement on therapeutic process of children with Down syndrome (DS) is important for language and communication development. The identification of the communicative skills presented by these children as well as the context influence in their performance as interlocutors, will contribute to the design of therapeutic interventions.
Pragmatics theories are helpful to language use studies, since it takes into account social and environmental aspects and considers adult-child interaction as a determinant factor for its occurrence.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research Group | – | –15 children with Down syndrome, observed in two interaction conditions: playing with their therapist (A) and playing with their caregiver (B). |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 15 children with Down syndrome aged from 5 to 8 years.
Key inclusion criteria (5 listed)
- genetic diagnosis of Down syndrome
- good health conditions
- normal results on audiologic evaluation
- pediatric and ear, nose and throat periodic check ups.
- attend speech-language therapy at the Speech Language Pathology Laboratory in Syndromes and Sensorimotor Deficits (SLPL-SSD) of the School of Medicine of the University of São Paulo.
Key exclusion criteria (2 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
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
Not reported in the source record.
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 16 Feb 2009.
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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
Eliza P Cunha, Ms student principal investigator
University of Sao Paulo
1 site 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 1 site 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 5 inclusion and 2 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 16 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 16 Feb 2009.