Back to resultsAugmentative and Alternative Communication (AAC) and Lexical Gain in Children With Down Syndrome
Primary Purpose
Down Syndrome
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
speech-language therapy with AAC intervention
Sponsored by
About this trial
This is an interventional treatment trial for Down Syndrome focused on measuring Down syndrome, communication AIDS for disabled, language development disorders, vocabulary, gestures, language tests, child
Eligibility 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
Sites / Locations
- University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SG
Arm Description
Study Group: five children with Down syndrome submitted to speech-language intervention with AAC intervention
Outcomes
Primary Outcome Measures
Performance on a initial and final lexical assessments, after 12 months of speech-language therapy
Secondary Outcome Measures
Performance on longitudinal follow-up of twelve months of speech-language therapy with AAC use
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00689988
Brief Title
Augmentative and Alternative Communication (AAC) and Lexical Gain in Children With Down Syndrome
Official Title
Augmentative and Alternative Communication and Lexical Gain in Children With Down Syndrome: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
Down syndrome, communication AIDS for disabled, language development disorders, vocabulary, gestures, language tests, child
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SG
Arm Type
Experimental
Arm Description
Study Group: five children with Down syndrome submitted to speech-language intervention with AAC intervention
Intervention Type
Behavioral
Intervention Name(s)
speech-language therapy with AAC intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Performance on a initial and final lexical assessments, after 12 months of speech-language therapy
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Performance on longitudinal follow-up of twelve months of speech-language therapy with AAC use
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra CF Pires, PhD student
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suelly CO Limongi, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy
City
São Paulo
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
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Augmentative and Alternative Communication (AAC) and Lexical Gain in Children With Down Syndrome
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