- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00033150
A Comparison of Language Intervention Programs
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.
Study Overview
Status
Conditions
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Kansas
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Lawrence, Kansas, United States, 66044
- Lawrence Public Schools USD 497
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Texas
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Pflugerville, Texas, United States, 78660
- Pflugerville Independent School District
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Collaborators and Investigators
Investigators
- Principal Investigator: Ronald Gillam, PhD, Pflugerville Independent School District
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U01DC004560 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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