Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000929000
Ethics application status
Approved
Date submitted
27/10/2010
Date registered
2/11/2010
Date last updated
2/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the lexicon of children with Down syndrome and typically developing same mental age
Scientific title
Vocabulary and language performance improvement comparison of the lexicon of children with Down syndrome and typically developing same mental age
Secondary ID [1] 252964 0
None
Universal Trial Number (UTN)
U1111-1117-5950
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Down Syndrome 258491 0
Language development 258492 0
Condition category
Condition code
Human Genetics and Inherited Disorders 258660 258660 0 0
Down's syndrome
Other 258661 258661 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We evaluated 40 participants. Tests were used to assess receptive and expressive vocabulary. Each participant was seen in 4 sessions of 50 minutes each.
The same evaluator applied the Peabody Picture Vocabulary Test and the Test ABFW Language of children - Vocabulary Part B, all participants in the evaluation sessions.
Each participant was seen in 4 sessions of 50 minutes each, one on one with a therapist, one session per week over 4 weeks
Intervention code [1] 257490 0
Not applicable
Comparator / control treatment
The control group consisted of 20 typically developing children and those submitted to the same assessment procedures that children with Down syndrome. The control children were matched with children with Down syndrome through sex and mental age.
Control group
Active

Outcomes
Primary outcome [1] 259513 0
Children with DS showed lower performance than children with typical development
Timepoint [1] 259513 0
Evaluations were performed during four sessions of 50 minutes, by Peabody Picture Vocabulary Test and the Early Language ABFW Test - Vocabulary Part B
Secondary outcome [1] 266110 0
There were statistically significant for receptive vocabulary and verbal description in the usual expressive vocabulary
Timepoint [1] 266110 0
Evaluations were performed during four sessions of 50 minutes, by Peabody Picture Vocabulary Test and the Early Language ABFW Test - Vocabulary Part B

Eligibility
Key inclusion criteria
Experimental group: diagnosis of Down's syndrome, aged 36 to 72 months without hearing loss or visual disabling.
Control group: having typical development, pair with the experimental group regarding sex and mental age without hearing loss or visual disabling.
Minimum age
36 Months
Maximum age
72 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Experimental group: hearing loss or disabling visual and other associated changes.
Control group: hearing loss or disabling visual and other associated changes.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 3001 0
Brazil
State/province [1] 3001 0

Funding & Sponsors
Funding source category [1] 257937 0
University
Name [1] 257937 0
Faculty of Dentistry of Bauru, University of Sao Paulo
Country [1] 257937 0
Brazil
Primary sponsor type
Other Collaborative groups
Name
FAPESP (Foundation for supporting research in the state of Sao Paulo)
Address
R. Pio XI, 1500 - Alto da Lapa - CEP 05468-901 - Sao Paulo/SP
Country
Brazil
Secondary sponsor category [1] 257128 0
None
Name [1] 257128 0
Address [1] 257128 0
Country [1] 257128 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259948 0
Ethics Committee on Human Research of the Faculty of Dentistry of Bauru, University of Sao Paulo
Ethics committee address [1] 259948 0
Ethics committee country [1] 259948 0
Brazil
Date submitted for ethics approval [1] 259948 0
25/03/2009
Approval date [1] 259948 0
29/04/2009
Ethics approval number [1] 259948 0
040/2009

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31836 0
Address 31836 0
Country 31836 0
Phone 31836 0
Fax 31836 0
Email 31836 0
Contact person for public queries
Name 15083 0
Amanda Tragueta Ferreira
Address 15083 0
Rua Albino Tambara, 4-40, Apto 111. Vl Universitaria. CEP: 17012-470. Bauru/SP
Country 15083 0
Brazil
Phone 15083 0
+55 (14) 9721 0848
Fax 15083 0
Email 15083 0
[email protected]
Contact person for scientific queries
Name 6011 0
Amanda Tragueta Ferreira
Address 6011 0
Rua Albino Tambara, 4-40, Apto 111. Vl Universitaria. CEP: 17012-470. Bauru/SP
Country 6011 0
Brazil
Phone 6011 0
+55 (14) 9721 0848
Fax 6011 0
Email 6011 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.