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OpenTrials
Completed

NCT Number: 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.

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Key information

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lawrence Public Schools USD 497, Lawrence, Kansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fast ForWord

Behavioral

Computer Assisted Language Intervention

Behavioral

Individual Language Intervention

Behavioral

Academic enrichment

Behavioral

Sponsors and collaborators

Lead sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Nih

Registry information

Important dates

Study start
2002
Study completion
2005
First posted
Apr 9, 2002
Registry last updated
Apr 24, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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