A Comparison of Language Intervention Programs

Language Disorders Clinical Trial

Official title:

A Comparison of Language Intervention Programs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00033150
• Other study ID #: UO1 DC 4560
• Status: Completed
• Phase: Phase 3
• First received: April 8, 2002
• Last updated: April 21, 2006
• Start date: June 2002
• Est. completion date: January 2005

Study information

• Verified date: April 2006
• Source: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 9 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Language Disorders

Intervention

Behavioral:
• Fast ForWord

• Computer Assisted Language Intervention

• Individual Language Intervention

• Academic enrichment

Locations

Country	Name	City	State
United States	Lawrence Public Schools USD 497	Lawrence	Kansas
United States	Pflugerville Independent School District	Pflugerville	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States,