Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-27 @ 10:26 AM
Study NCT ID:
NCT00607334
Status:
COMPLETED
Last Update Posted:
2008-02-05
First Post:
2008-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Experimental Word Learning in Children With and Without Language Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007805', 'term': 'Language Development Disorders'}], 'ancestors': [{'id': 'D007806', 'term': 'Language Disorders'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-22', 'studyFirstSubmitDate': '2008-01-22', 'studyFirstSubmitQcDate': '2008-01-22', 'lastUpdatePostDateStruct': {'date': '2008-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance on a post-test administered after every word-learning session.', 'timeFrame': 'Three weeks'}], 'secondaryOutcomes': [{'measure': 'Occurence of correct spontaneous productions of the taught words during the experimental procedure', 'timeFrame': 'Three weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Child Language', 'Language Therapy', 'Vocabulary'], 'conditions': ['Developmental Language Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the performances of normally developing children and children with Language Impairment (LI) in three different experimental settings designed to promote vocabulary acquisition. This comparison will also provide evidence to support different intervention approaches designed to increase vocabulary abilities, which has been proved to be one of the major deficits of young children with LI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '47 Months', 'minimumAge': '36 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For GP subjects: - diagnosis of Language Impairment\n* enrolled in language therapy\n* age between 3:0 (years:months) and 3:11\n* For GC subjects: - normal performance in a language screening procedure\n* normal performance in an expressive vocabulary test\n\nExclusion Criteria:\n\n* For GP subjects: - hearing impairments\n* diagnosed neurological or behavioral conditions\n* major cognitive impairment\n* For GC subjects: - communication complaints from caregivers\n* history of previous enrollment in language therapy'}, 'identificationModule': {'nctId': 'NCT00607334', 'briefTitle': 'Experimental Word Learning in Children With and Without Language Impairment', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Experimental Word Learning in Children With Normal Development and Children With Language Impairment', 'orgStudyIdInfo': {'id': '24061316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GP', 'description': 'Children with Developmental Language Impairments were enrolled in this group.', 'interventionNames': ['Behavioral: Word-learning']}, {'type': 'EXPERIMENTAL', 'label': 'GC', 'description': 'Children with normal language development were enrolled in this group.', 'interventionNames': ['Behavioral: Word-learning']}], 'interventions': [{'name': 'Word-learning', 'type': 'BEHAVIORAL', 'description': 'Exposure to five nonwords for three sessions of controlled interaction with the experimenter', 'armGroupLabels': ['GP']}, {'name': 'Word-learning', 'type': 'BEHAVIORAL', 'description': 'Exposure to five nonwords for three sessions of controlled interaction with the experimenter', 'armGroupLabels': ['GC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'USP - Faculty of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Debora M. Befi-Lopes, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Juliana P. Gândara, PhD student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Debora Maria Befi-Lopes', 'oldOrganization': 'University of São Paulo'}}}}