Language DisordersPhase 3NCT00033150
A Comparison of Language Intervention Programs
A Phase 3 study testing Fast ForWord, Computer Assisted Language Intervention and Individual Language Intervention in people with Language Disorders, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Language Disorders
- What is being tested?
- Fast ForWord, Computer Assisted Language Intervention and Individual Language Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 216 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2002to Jan 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lawrence Public Schools USD 497
Lawrence, Kansas, 66044
Pflugerville Independent School District
Pflugerville, Texas, 78660
About this study
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.
Read more
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.
- Conditions
- Language Disorders
- Being tested
- Fast ForWord, Computer Assisted Language Intervention, Individual Language Intervention, Academic enrichment
- Keywords
- Specific Language Impairment, Fast ForWord, Language therapy, Auditory processing
- Medical subject headings
- Language Disorders, Specific Language Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast ForWordBehavioural
Computer Assisted Language InterventionBehavioural
Individual Language InterventionBehavioural
Academic enrichmentBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2002 (estimated)
- Study startJun 2002
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 216 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Ronald Gillam, PhD, Principal investigator, Pflugerville Independent School District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00033150
- Sponsor's protocol ID
- U01DC004560
- Status last verified
- Apr 2006
- First submitted
- 8 Apr 2002
- Last updated
- 24 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Language Intervention Programs
- ClinicalTrials.gov ID
- NCT00033150
- Acronym / sponsor ID
- U01DC004560
- Conditions
- Language Disorders
- Keywords
- Specific Language Impairment, Fast ForWord, Language therapy, Auditory processing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)US National Institutes of Health
- Study start
- Jun 2002
- Study completion
- Jan 2005
- First posted
- 9 Apr 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast ForWord | Behavioural | – |
| Computer Assisted Language Intervention | Behavioural | – |
| Individual Language Intervention | Behavioural | – |
| Academic enrichment | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Gillam, PhD principal investigator
Pflugerville Independent School District
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fast ForWord, Computer Assisted Language Intervention and Individual Language Intervention in people with Language Disorders, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2006; AzTrials last refreshed its copy on 28 Oct 2026.