Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-31 @ 9:40 AM
Study NCT ID:
NCT00033150
Status:
COMPLETED
Last Update Posted:
2006-04-24
First Post:
2002-04-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Language Intervention Programs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D000080888', 'term': 'Specific Language Disorder'}], 'ancestors': [{'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007805', 'term': 'Language Development Disorders'}, {'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-04', 'completionDateStruct': {'date': '2005-01'}, 'lastUpdateSubmitDate': '2006-04-21', 'studyFirstSubmitDate': '2002-04-08', 'studyFirstSubmitQcDate': '2002-04-08', 'lastUpdatePostDateStruct': {'date': '2006-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-04-09', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Specific Language Impairment', 'Fast ForWord', 'Language therapy', 'Auditory processing'], 'conditions': ['Language Disorders']}, 'descriptionModule': {'briefSummary': 'Brief Summary:\n\nNearly 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.\n\nThis 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 6 to 9 years\n* score between 75 and 125 on the Matrices subtest of the Kaufman Brief Intelligence Test\n* Speaking Quotient of 79 or lower on the Test of Language Development: Primary: 3rd Edition\n\nExclusion Criteria:\n\n* 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\n* Failure of a hearing screening test\n* An episode of otitis media in the previous 12 months\n* Evidence of focal brain lesion, traumatic brain injury, cerebral palsy, or seizure disorder\n* Abnormality of oral structure or function impeding normal language production'}, 'identificationModule': {'nctId': 'NCT00033150', 'briefTitle': 'A Comparison of Language Intervention Programs', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Deafness and Other Communication Disorders (NIDCD)'}, 'officialTitle': 'A Comparison of Language Intervention Programs', 'orgStudyIdInfo': {'id': 'U01DC004560', 'link': 'https://reporter.nih.gov/quickSearch/U01DC004560', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fast ForWord', 'type': 'BEHAVIORAL'}, {'name': 'Computer Assisted Language Intervention', 'type': 'BEHAVIORAL'}, {'name': 'Individual Language Intervention', 'type': 'BEHAVIORAL'}, {'name': 'Academic enrichment', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66044', 'city': 'Lawrence', 'state': 'Kansas', 'country': 'United States', 'facility': 'Lawrence Public Schools USD 497', 'geoPoint': {'lat': 38.97167, 'lon': -95.23525}}, {'zip': '78660', 'city': 'Pflugerville', 'state': 'Texas', 'country': 'United States', 'facility': 'Pflugerville Independent School District', 'geoPoint': {'lat': 30.43937, 'lon': -97.62}}], 'overallOfficials': [{'name': 'Ronald Gillam, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pflugerville Independent School District'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}}}}