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

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Syndrome
Down Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 18, 2014