Down SyndromeNCT00689988
Augmentative and Alternative Communication (AAC) and Lexical Gain in Children With Down Syndrome
A study testing speech-language therapy with AAC intervention in people with Down Syndrome, run by University of Sao Paulo at 1 site in Brazil.
Trial 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 more about this study
- Who is it for?
- Ages 5 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- What is being tested?
- speech-language therapy with AAC intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2005to Jun 2008
- Phase
- Interventional
- 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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- genetic diagnosis of Down syndrome
- be at the preoperational period
- good health conditions
- expressive language impairment (communication by vocal and gestures, predominantly)
Who cannot join
- presence of major malformations
- presence of another genetic syndrome
- severe neonatal asphyxia, hearing impairment or visual
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
About this study
Official title: Augmentative and Alternative Communication and Lexical Gain in Children With Down Syndrome: Pilot Study
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.
- Conditions
- Down Syndrome
- Being tested
- speech-language therapy with AAC intervention
- Keywords
- Down syndrome, communication AIDS for disabled, language development disorders, vocabulary, gestures, language tests, child
- Medical subject headings
- Down Syndrome, Language Development Disorders, Gestures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speech-language therapy with AAC interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| SG | Experimental | Study Group: five children with Down syndrome submitted to speech-language intervention with AAC intervention Receives: Behavioral: speech-language therapy with AAC intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on a initial and final lexical assessments, after 12 months of speech-language therapy
Measured: 12 months
Secondary outcomes (1)
Performance on longitudinal follow-up of twelve months of speech-language therapy with AAC use
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startJul 2005
- Primary completionOct 2007
- Study completionJun 2008
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Sandra CF Pires, PhD student, Principal investigator, University of Sao PauloSuelly CO Limongi, PhD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689988
- Sponsor's protocol ID
- 05/1149
- Status last verified
- Jun 2008
- First submitted
- 2 Jun 2008
- Last updated
- 4 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentative and Alternative Communication and Lexical Gain in Children With Down Syndrome: Pilot Study
- ClinicalTrials.gov ID
- NCT00689988
- Acronym / sponsor ID
- 05/1149
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, communication AIDS for disabled, language development disorders, vocabulary, gestures, language tests, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 4 Jun 2008 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SG | Experimental | Behavioral: speech-language therapy with AAC interventionStudy Group: five children with Down syndrome submitted to speech-language intervention with AAC intervention |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- genetic diagnosis of Down syndrome
- be at the preoperational period
- good health conditions
- expressive language impairment (communication by vocal and gestures, predominantly)
Key exclusion criteria (3 listed)
- presence of major malformations
- presence of another genetic syndrome
- severe neonatal asphyxia, hearing impairment or visual
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| speech-language therapy with AAC interventionspeech-language intervention in weekly 40-minutes sessions, without the presence of parents or caregivers, and 5 to 10-minutes to parents training and orientation | Behavioural | SG |
Primary outcome
Performance on a initial and final lexical assessments, after 12 months of speech-language therapy
Time frame: 12 months
1 secondary outcome
Performance on longitudinal follow-up of twelve months of speech-language therapy with AAC use
Time frame: 12 months
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 4 Jun 2008.
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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.
Sandra CF Pires, PhD student principal investigator
University of Sao Paulo
Suelly CO Limongi, PhD study chair
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?
A study testing speech-language therapy with AAC intervention in people with 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 4 inclusion and 3 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 4 Jun 2008. 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.
What does the primary outcome measure?
Performance on a initial and final lexical assessments, after 12 months of speech-language therapy (time frame: 12 months). It is what the study was designed to measure, not a finding.
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 4 Jun 2008; AzTrials last refreshed its copy on 6 Nov 2026.