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

June 3, 2008 updated by: University of Sao Paulo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil
        • University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Performance on a initial and final lexical assessments, after 12 months of speech-language therapy
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Performance on longitudinal follow-up of twelve months of speech-language therapy with AAC use
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Sandra CF Pires, PhD student, University of Sao Paulo
  • Study Chair: Suelly CO Limongi, PhD, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

June 2, 2008

First Submitted That Met QC Criteria

June 3, 2008

First Posted (Estimate)

June 4, 2008

Study Record Updates

Last Update Posted (Estimate)

June 4, 2008

Last Update Submitted That Met QC Criteria

June 3, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05/1149

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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