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

Down Syndrome Clinical Trial

Official title:

Augmentative and Alternative Communication and Lexical Gain in Children With Down Syndrome: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689988
• Other study ID #: 05/1149
• Status: Completed
• Phase: N/A
• First received: June 2, 2008
• Last updated: June 3, 2008
• Start date: July 2005
• Est. completion date: June 2008

Study information

• Verified date: June 2008
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 11 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

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

Locations

Country	Name	City	State
Brazil	University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance on a initial and final lexical assessments, after 12 months of speech-language therapy		12 months	No
Secondary	Performance on longitudinal follow-up of twelve months of speech-language therapy with AAC use		12 months	No