NCT00689988

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
Last Updated

June 4, 2008

Status Verified

June 1, 2008

Enrollment Period

2.3 years

First QC Date

June 2, 2008

Last Update Submit

June 3, 2008

Conditions

Keywords

Down syndromecommunication AIDS for disabledlanguage development disordersvocabularygestureslanguage testschild

Outcome Measures

Primary Outcomes (1)

  • Performance on a initial and final lexical assessments, after 12 months of speech-language therapy

    12 months

Secondary Outcomes (1)

  • Performance on longitudinal follow-up of twelve months of speech-language therapy with AAC use

    12 months

Study Arms (1)

SG

EXPERIMENTAL

Study Group: five children with Down syndrome submitted to speech-language intervention with AAC intervention

Behavioral: speech-language therapy with AAC intervention

Interventions

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

SG

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • genetic diagnosis of Down syndrome
  • be at the preoperational period
  • good health conditions
  • expressive language impairment (communication by vocal and gestures, predominantly)

You may not qualify if:

  • presence of major malformations
  • presence of another genetic syndrome
  • severe neonatal asphyxia, hearing impairment or visual

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Down SyndromeLanguage Development DisordersGestures

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornLanguage DisordersCommunication DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsKinesicsNonverbal CommunicationCommunicationBehavior

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Sandra CF Pires, PhD student

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR
  • Suelly CO Limongi, PhD

    University of Sao Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2008

First Posted

June 4, 2008

Study Start

July 1, 2005

Primary Completion

October 1, 2007

Study Completion

June 1, 2008

Last Updated

June 4, 2008

Record last verified: 2008-06

Locations