NCT00033150

Brief Summary

Brief Summary: Nearly 7% of elementary school children present with difficulties learning and using language. Unfortunately, language impairments are often long lasting and may have serious social, academic, and vocational ramifications. More than 1 million children receive language intervention in the public schools each year, and many more are seen in hospitals and other clinical settings. This randomized clinical trial compares the language outcomes of Fast ForWord to two other interventions (computer assisted language intervention without acoustically modified speech and individual language intervention) and to the outcomes of an academic enrichment (control) condition. Each year for 3 years, children will be randomly assigned to each of the four conditions at three regional sites (Austin, Texas, Dallas, Texas, and Lawrence, Kansas). The treatments will be administered in special summer programs. The primary research question is which intervention results in the most improvement in the composite language score from the Oral and Written Language Scales. Secondary questions include which intervention results in the greatest gains in conversational language,which intervention results in the greatest gains 3 and 6 months after training, which intervention results in the greatest improvement in auditory perception, and which intervention is the most cost effective. The results of the study will have theoretical and practical value. Theoretically, the study tests the temporal processing hypothesis of language impairment. Practically, the study will describe and compare the language, communication, auditory processing and academic outcomes of different language interventions. The study will help clinicians and administrators choose the most effective and least expensive treatment for the children they serve.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2002

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2002

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2002

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

April 24, 2006

Status Verified

April 1, 2006

First QC Date

April 8, 2002

Last Update Submit

April 21, 2006

Conditions

Keywords

Specific Language ImpairmentFast ForWordLanguage therapyAuditory processing

Interventions

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age 6 to 9 years
  • score between 75 and 125 on the Matrices subtest of the Kaufman Brief Intelligence Test
  • Speaking Quotient of 79 or lower on the Test of Language Development: Primary: 3rd Edition

You may not qualify if:

  • Previous participation in 8 or more hours of language intervention or classroom activities using any of the Fast ForWord, Laureate, or Earobics speech-language or reading software and/or the Lindamood-Bell auditory discrimination training
  • Failure of a hearing screening test
  • An episode of otitis media in the previous 12 months
  • Evidence of focal brain lesion, traumatic brain injury, cerebral palsy, or seizure disorder
  • Abnormality of oral structure or function impeding normal language production

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lawrence Public Schools USD 497

Lawrence, Kansas, 66044, United States

Location

Pflugerville Independent School District

Pflugerville, Texas, 78660, United States

Location

MeSH Terms

Conditions

Language DisordersSpecific Language Disorder

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLanguage Development DisordersLearning DisabilitiesNeurodevelopmental DisordersMental Disorders

Study Officials

  • Ronald Gillam, PhD

    Pflugerville Independent School District

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 8, 2002

First Posted

April 9, 2002

Study Start

June 1, 2002

Study Completion

January 1, 2005

Last Updated

April 24, 2006

Record last verified: 2006-04

Locations