Augmentative and Alternative Communication (AAC) and Lexical Gain in Children With Down Syndrome
1 other identifier
interventional
5
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2005
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 2, 2008
CompletedFirst Posted
Study publicly available on registry
June 4, 2008
CompletedJune 4, 2008
June 1, 2008
2.3 years
June 2, 2008
June 3, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Performance on a initial and final lexical assessments, after 12 months of speech-language therapy
12 months
Secondary Outcomes (1)
Performance on longitudinal follow-up of twelve months of speech-language therapy with AAC use
12 months
Study Arms (1)
SG
EXPERIMENTALStudy Group: five children with Down syndrome submitted to speech-language intervention with AAC intervention
Interventions
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
Eligibility Criteria
You may qualify if:
- genetic diagnosis of Down syndrome
- be at the preoperational period
- good health conditions
- expressive language impairment (communication by vocal and gestures, predominantly)
You may not qualify if:
- presence of major malformations
- presence of another genetic syndrome
- severe neonatal asphyxia, hearing impairment or visual
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy
São Paulo, São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra CF Pires, PhD student
University of Sao Paulo
- STUDY CHAIR
Suelly CO Limongi, PhD
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 2, 2008
First Posted
June 4, 2008
Study Start
July 1, 2005
Primary Completion
October 1, 2007
Study Completion
June 1, 2008
Last Updated
June 4, 2008
Record last verified: 2008-06