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CompletedNCT00689988Updated Jun 4, 2008

Augmentative and Alternative Communication (AAC) and Lexical Gain in Children With Down Syndrome

An interventional study of speech-language therapy with AAC intervention in Down Syndrome, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 5 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-06-04.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Non-randomized
Ages
5 Years to 11 Years
Sex
All
01

Study summary

Children with Down syndrome (DS) have language development particularities that have negative effects in the communication capacity. By this way, Augmentative and Alternative Communication (AAC) is indicated to this population. The aim of this study was to verify the AAC impact in the lexical gain of children with DS.

Read the detailed description

Five children with DS, with the same cognitive level, participated in this study. Longitudinal follow-up of twelve months of speech-language therapy with AAC use was undertaken. A lexical evaluation was done at the beginning and the end of this follow-up. Correct responses in the lexical evaluation were increased, but not necessarily in the spoken modality. The comparisons showed significant results in use of substitutions processes, and to no-answers.

02

Conditions studied

  • Down Syndrome

Keywords

  • Down syndrome
  • communication AIDS for disabled
  • language development disorders
  • vocabulary
  • gestures
  • language tests
  • child
03

In context

Down Syndrome

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

This study's enrollment of 5 is below the median of 36 across 285 interventional studies indexed under Down Syndrome.

Browse Down Syndrome studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,030 studies on the registry; 92 are open to participants now.

Of its 8 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 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • genetic diagnosis of Down syndrome
  • be at the preoperational period
  • good health conditions
  • expressive language impairment (communication by vocal and gestures, predominantly)

Exclusion criteria

Exclusion Criteria:

  • presence of major malformations
  • presence of another genetic syndrome
  • severe neonatal asphyxia, hearing impairment or visual
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    SG

    Study Group: five children with Down syndrome submitted to speech-language intervention with AAC intervention

    Behavioral: speech-language therapy with AAC intervention

Interventions

  • Behavioralspeech-language therapy with AAC intervention

    speech-language intervention in weekly 40-minutes sessions, without the presence of parents or caregivers, and 5 to 10-minutes to parents training and orientation

06

What researchers measure

Primary outcomes

  1. Performance on a initial and final lexical assessments, after 12 months of speech-language therapy

    Time frame: 12 months

Secondary outcomes

  1. Performance on longitudinal follow-up of twelve months of speech-language therapy with AAC use

    Time frame: 12 months

07

Study locations

1 site
  • University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy
    São Paulo, São Paulo, Brazil
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2005, a primary completion of Oct 2007 and a completion of Jun 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 2, 2008
First posted
Jun 4, 2008
Start
Jul 2005
Primary completionActual
Oct 2007
CompletionActual
Jun 2008
Last update
Jun 4, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00689988
First posted
Jun 4, 2008
Start date
Jul 2005
Primary completion
Oct 2007
Completion
Jun 2008
Last update
Jun 4, 2008

Study contacts

Sandra CF Pires, PhD student
principal investigator · University of Sao Paulo
Suelly CO Limongi, PhD
study chair · 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 Jun 2008. You cannot join it, but the record below documents what was studied.

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