NCT00607334

Brief Summary

The purpose of this study is to compare the performances of normally developing children and children with Language Impairment (LI) in three different experimental settings designed to promote vocabulary acquisition. This comparison will also provide evidence to support different intervention approaches designed to increase vocabulary abilities, which has been proved to be one of the major deficits of young children with LI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2003

Longer than P75 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, 2003

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
Last Updated

February 5, 2008

Status Verified

October 1, 2007

Enrollment Period

3.9 years

First QC Date

January 22, 2008

Last Update Submit

January 22, 2008

Conditions

Keywords

Child LanguageLanguage TherapyVocabulary

Outcome Measures

Primary Outcomes (1)

  • Performance on a post-test administered after every word-learning session.

    Three weeks

Secondary Outcomes (1)

  • Occurence of correct spontaneous productions of the taught words during the experimental procedure

    Three weeks

Study Arms (2)

GP

EXPERIMENTAL

Children with Developmental Language Impairments were enrolled in this group.

Behavioral: Word-learning

GC

EXPERIMENTAL

Children with normal language development were enrolled in this group.

Behavioral: Word-learning

Interventions

Word-learningBEHAVIORAL

Exposure to five nonwords for three sessions of controlled interaction with the experimenter

GP

Eligibility Criteria

Age36 Months - 47 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • For GP subjects: - diagnosis of Language Impairment
  • enrolled in language therapy
  • age between 3:0 (years:months) and 3:11
  • For GC subjects: - normal performance in a language screening procedure
  • normal performance in an expressive vocabulary test

You may not qualify if:

  • For GP subjects: - hearing impairments
  • diagnosed neurological or behavioral conditions
  • major cognitive impairment
  • For GC subjects: - communication complaints from caregivers
  • history of previous enrollment in language therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USP - Faculty of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Debora M. Befi-Lopes, PhD

    University of Sao Paulo

    STUDY CHAIR
  • Juliana P. Gândara, PhD student

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 5, 2008

Study Start

July 1, 2003

Primary Completion

June 1, 2007

Study Completion

July 1, 2007

Last Updated

February 5, 2008

Record last verified: 2007-10

Locations