CClinicalTrials.gg
CompletedNCT00844259Updated Feb 16, 2009

Functional Communicative Profile of Children With Down Syndrome

An observational study in Down Syndrome, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 5 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-02-16.

Sponsored by University of Sao Paulo · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Cross-sectional
Enrollment
15
Ages
5 Years to 8 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Down Syndrome

Keywords

  • Down syndrome
  • Pragmatics
  • Language Development
03

In context

Down Syndrome

432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.

This study's enrollment of 15 is below the median of 150 across 141 observational studies indexed under Down Syndrome.

Browse Down Syndrome studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

15 children with Down syndrome aged from 5 to 8 years.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-crossover
Time perspective
Cross-sectional
Enrollment
15 participants (actual)

Groups and cohorts

  • Research Group

    15 children with Down syndrome, observed in two interaction conditions: playing with their therapist (A) and playing with their caregiver (B).

06

Study locations

1 site
  • University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy
    Sao Paulo, 05360-160, Brazil
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00844259
Lead sponsor
University of Sao Paulo
First posted
Feb 16, 2009
Start date
Jul 2006
Primary completion
Oct 2007
Completion
Oct 2007
Last update
Feb 16, 2009

Study contacts

Suelly CO Limongi, PhD
study chair · University of Sao Paulo
Eliza P Cunha, Ms student
principal investigator · University of Sao Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion