Down SyndromeNCT00952354
Oral Language in Children With Down Syndrome
An observational study of Down Syndrome, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The objective of this research is to verify the language of children with Down syndrome concerning lexical, syntactic and semantic aspects using MLU. The hypothesis is that children with Down syndrome will present low performance, regarding not only the quantitative measures as MLU-m, MLU-w, GM-1 and GM-2, but also… Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2007to Aug 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 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 60 children with Down syndrome aged from 3 to 10 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
Official title: Oral Language in Children With Down Syndrome: Lexical, Syntactic and Semantic Aspects
The objective of this research is to verify the language of children with Down syndrome concerning lexical, syntactic and semantic aspects using MLU. The hypothesis is that children with Down syndrome will present low performance, regarding not only the quantitative measures as MLU-m, MLU-w, GM-1 and GM-2, but also regarding the qualitative aspects of their production, when compared to children with typical development.
Read the detailed description
One of the alternatives to observe and assess language development and language disorders is to analyze spontaneous language samples, which allos the identification of qualitative and quantitative aspects. The analysis involves the MLU-morphemes, MLU-words and words classes. All words produced are analyzed, including interjections, adverbs and adjectives.Word classes with grammatical characteristics present lower averages, as prepositions and conjunctions. Reference parameters are the ones of the spoken language. The objective assessment with qualitative and quantitative data may help the speech and language pathologist/therapist to determine therapeutic guidelines to each patient.
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, MLU, language development, language assessment
- 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 | 60 children aged from 3 to 10 years, both genders, observed in a symbolic play situation with their language therapists |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startAug 2007
- Primary completionApr 2009
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Investigators
- Suelly CO Limongi, PhD, Study chair, University of Sao PauloRosangela V Andrade, PhD, Principal investigator, University of Sao PauloFabiola C Flabiano, PhD student, Principal investigator, University of Sao PauloPorto Eliza, Ms student, Principal investigator, University of Sao PauloAngela MA Carvalho, Ms student, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952354
- Sponsor's protocol ID
- 473492/2007-5
- Other IDs
- CNPq-473492/2007-5
- Status last verified
- Aug 2009
- First submitted
- 3 Aug 2009
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Limongi SC, Oliveira Ede F, Ienne LM, Andrade RV, Carvalho AM. The use of nouns and verbs by children with Down syndrome in two different situations. Codas. 2013;25(3):262-7. doi: 10.1590/s2317-17822013000300012. English, Portuguese.
PubMed 24408338Marques SF, Limongi SC. [Mean length utterance (MLU) as a measure of language development of children with Down syndrome]. J Soc Bras Fonoaudiol. 2011;23(2):152-7. doi: 10.1590/s2179-64912011000200012. Portuguese.
PubMed 21829931
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Language in Children With Down Syndrome: Lexical, Syntactic and Semantic Aspects
- ClinicalTrials.gov ID
- NCT00952354
- Acronym / sponsor ID
- 473492/2007-5
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, MLU, language development, language assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Aug 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Aug 2009 (estimated)
- First posted
- 6 Aug 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 objective of this research is to verify the language of children with Down syndrome concerning lexical, syntactic and semantic aspects using MLU. The hypothesis is that children with Down syndrome will present low performance, regarding not only the quantitative measures as MLU-m, MLU-w, GM-1 and GM-2, but also regarding the qualitative aspects of their production, when compared to children with typical development.
Detailed description
One of the alternatives to observe and assess language development and language disorders is to analyze spontaneous language samples, which allos the identification of qualitative and quantitative aspects. The analysis involves the MLU-morphemes, MLU-words and words classes. All words produced are analyzed, including interjections, adverbs and adjectives.Word classes with grammatical characteristics present lower averages, as prepositions and conjunctions. Reference parameters are the ones of the spoken language. The objective assessment with qualitative and quantitative data may help the speech and language pathologist/therapist to determine therapeutic guidelines to each patient.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| research group | – | –60 children aged from 3 to 10 years, both genders, observed in a symbolic play situation with their language therapists |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 60 children with Down syndrome aged from 3 to 10 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
- Derived from this study: PubMed 24408338Limongi SC, Oliveira Ede F, Ienne LM, Andrade RV, Carvalho AM. The use of nouns and verbs by children with Down syndrome in two different situations. Codas. 2013;25(3):262-7. doi: 10.1590/s2317-17822013000300012. English, Portuguese.
- Derived from this study: PubMed 21829931Marques SF, Limongi SC. [Mean length utterance (MLU) as a measure of language development of children with Down syndrome]. J Soc Bras Fonoaudiol. 2011;23(2):152-7. doi: 10.1590/s2179-64912011000200012. Portuguese.
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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
Rosangela V Andrade, PhD principal investigator
University of Sao Paulo
Fabiola C Flabiano, PhD 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: status not confirmed, as of the sponsor's last update on 6 Aug 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?
Results are not available in the source record.
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?
On the ClinicalTrials.gov record for NCT00952354, which also lists 2 linked publications.
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 6 Aug 2009.