Augmentative and Alternative Communication (AAC) and Lexical Gain in Children With Down Syndrome
This study has been completed.
Sponsor:
University of Sao Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00689988
First received: June 2, 2008
Last updated: June 3, 2008
Last verified: June 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Down Syndrome |
Behavioral: speech-language therapy with AAC intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Augmentative and Alternative Communication and Lexical Gain in Children With Down Syndrome: Pilot Study |
Resource links provided by NLM:
Further study details as provided by University of Sao Paulo:
Primary Outcome Measures:
- Performance on a initial and final lexical assessments, after 12 months of speech-language therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Performance on longitudinal follow-up of twelve months of speech-language therapy with AAC use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 5 |
| Study Start Date: | July 2005 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SG
Study Group: five children with Down syndrome submitted to speech-language intervention with AAC intervention
|
Behavioral: speech-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
|
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.
Eligibility| Ages Eligible for Study: | 5 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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:
- presence of major malformations
- presence of another genetic syndrome
- severe neonatal asphyxia, hearing impairment or visual
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689988
Locations
| Brazil | |
| University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy | |
| São Paulo, SP, Brazil | |
Sponsors and Collaborators
University of Sao Paulo
Investigators
| Principal Investigator: | Sandra CF Pires, PhD student | University of São Paulo |
| Study Chair: | Suelly CO Limongi, PhD | University of São Paulo |
More Information
No publications provided
| Responsible Party: | Suelly Cecilia Olivan Limongi, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT00689988 History of Changes |
| Other Study ID Numbers: | 05/1149 |
| Study First Received: | June 2, 2008 |
| Last Updated: | June 3, 2008 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by University of Sao Paulo:
|
Down syndrome communication AIDS for disabled language development disorders vocabulary |
gestures language tests child |
Additional relevant MeSH terms:
|
Down Syndrome Mental Retardation Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |
Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on June 17, 2013