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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00607334
Other study ID # 24061316
Secondary ID
Status Completed
Phase N/A
First received January 22, 2008
Last updated January 22, 2008
Start date July 2003
Est. completion date July 2007

Study information

Verified date October 2007
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

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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date July 2007
Est. primary completion date June 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 36 Months to 47 Months
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Word-learning
Exposure to five nonwords for three sessions of controlled interaction with the experimenter
Word-learning
Exposure to five nonwords for three sessions of controlled interaction with the experimenter

Locations

Country Name City State
Brazil USP - Faculty 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 post-test administered after every word-learning session. Three weeks No
Secondary Occurence of correct spontaneous productions of the taught words during the experimental procedure Three weeks No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT00625261 - Effectiveness of Early Parent-Based Language Intervention Phase 3
Not yet recruiting NCT04253600 - Understanding the Predictive Factors and the Neurocognitive Basis of Developmental Language Disorder N/A