Experimental Word Learning in Children With and Without L... | NCT00607334

Studies
Experimental Word Learning in Children With and Without Language Impairment

NCT00607334

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Feb 5, 2008Estimated

Enrollment

51Actual

Phase

Not Applicable

Conditions

Developmental Language Disorders

Interventions

Word-learning
Word-learning

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2003

Primary Completion Date

Jun 2007Actual

Completion Date

Jul 2007Actual

First Submitted Date

Jan 22, 2008

First Submission Date that Met QC Criteria

Jan 22, 2008

First Posted Date

Feb 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2008

Last Update Posted Date

Feb 5, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Word-learning	Behavioral	Exposure to five nonwords for three sessions of controlled interaction with the experimenter	GP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Performance on a post-test administered after every word-learning session.		Three weeks

Secondary Outcomes

Measure	Description	Time Frame
Occurence of correct spontaneous productions of the taught words during the experimental procedure		Three weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

36 Months

Maximum Age

47 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Debora M. Befi-Lopes, PhD	University of Sao Paulo	Study Chair
Juliana P. Gândara, PhD student	University of Sao Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
USP - Faculty of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy		São Paulo	São Paulo		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D007805	Language Development Disorders

Ancestor Terms

ID	Term
D007806	Language Disorders
D003147	Communication Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided