Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT00840060
Status:
COMPLETED
Last Update Posted:
2012-05-15
First Post:
2009-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of AMALS in Treating Language Impairment in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007806', 'term': 'Language Disorders'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'monica.harn@lamar.edu', 'phone': '409-880-8174', 'title': 'Monica Harn', 'organization': 'Lamar University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Problems with stratification according to dialect prior to randomization lead to difficulty interpreting results related to dialect'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Addressing Multiple Aspects of Language Simultaneously', 'description': 'Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Discrete Trial Approach', 'description': 'Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Language Sample Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Addressing Multiple Aspects of Language Simultaneously', 'description': 'Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.'}, {'id': 'OG001', 'title': 'Discrete Trial Approach', 'description': 'Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.'}], 'classes': [{'title': 'Interpretive utterances: pre-treatment', 'categories': [{'measurements': [{'value': '17.33', 'spread': '3.31', 'groupId': 'OG000'}, {'value': '18.00', 'spread': '3.22', 'groupId': 'OG001'}]}]}, {'title': 'Interpretive utterances: post-treatment', 'categories': [{'measurements': [{'value': '39.35', 'spread': '4.04', 'groupId': 'OG000'}, {'value': '26.38', 'spread': '3.92', 'groupId': 'OG001'}]}]}, {'title': 'Interpretive utterances: 1-month follow-up', 'categories': [{'measurements': [{'value': '39.70', 'spread': '4.16', 'groupId': 'OG000'}, {'value': '20.55', 'spread': '4.04', 'groupId': 'OG001'}]}]}, {'title': 'T-units: pre-treatment', 'categories': [{'measurements': [{'value': '52.30', 'spread': '21.00', 'groupId': 'OG000'}, {'value': '53.77', 'spread': '22.70', 'groupId': 'OG001'}]}]}, {'title': 'T-units: post-treatment', 'categories': [{'measurements': [{'value': '80.94', 'spread': '13.18', 'groupId': 'OG000'}, {'value': '69.78', 'spread': '20.19', 'groupId': 'OG001'}]}]}, {'title': 'T-units: one-month follow-up', 'categories': [{'measurements': [{'value': '74.88', 'spread': '16.99', 'groupId': 'OG000'}, {'value': '55.83', 'spread': '29.48', 'groupId': 'OG001'}]}]}, {'title': 'Frequency of copula (is/are): pre-treatment', 'categories': [{'measurements': [{'value': '56.00', 'spread': '33.24', 'groupId': 'OG000'}, {'value': '71.00', 'spread': '33.59', 'groupId': 'OG001'}]}]}, {'title': 'Frequency of copula (is/are): post-treatment', 'categories': [{'measurements': [{'value': '77.05', 'spread': '26.78', 'groupId': 'OG000'}, {'value': '76.43', 'spread': '26.12', 'groupId': 'OG001'}]}]}, {'title': 'Frequency of copula (is/are): 1-month follow-up', 'categories': [{'measurements': [{'value': '76.94', 'spread': '25.72', 'groupId': 'OG000'}, {'value': '75.81', 'spread': '23.55', 'groupId': 'OG001'}]}]}, {'title': 'Frequency of auxiliary (is/are): pre-treatment', 'categories': [{'measurements': [{'value': '40.11', 'spread': '38.87', 'groupId': 'OG000'}, {'value': '48.87', 'spread': '35.13', 'groupId': 'OG001'}]}]}, {'title': 'Frequency of auxiliary (is/are): post-treatment', 'categories': [{'measurements': [{'value': '65.23', 'spread': '23.73', 'groupId': 'OG000'}, {'value': '59.12', 'spread': '26.02', 'groupId': 'OG001'}]}]}, {'title': 'Frequency of auxiliary (is/are): 1-month follow-up', 'categories': [{'measurements': [{'value': '50.23', 'spread': '34.15', 'groupId': 'OG000'}, {'value': '48.68', 'spread': '24.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up.', 'description': 'Samples were transcribed and segmented by utterance. Each was coded categorically. Reported measures include percentage of utterances at the interpretive/inferential label, percentage of utterances with one or more t-unit (i.e., noun phrase + verb phrase), percentage of utterances that required copula (is/are) or auxiliary (is/are) that were produced.', 'unitOfMeasure': 'Percentage of utterances', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Language samples were collected for all children participating in either treatment condition.'}, {'type': 'PRIMARY', 'title': 'Number of Verb Structures Per Utterance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Addressing Multiple Aspects of Language Simultaneously', 'description': 'Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.'}, {'id': 'OG001', 'title': 'Discrete Trial Approach', 'description': 'Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.'}], 'classes': [{'title': 'Novel verb structures per utterance: pre-treatment', 'categories': [{'measurements': [{'value': '3.52', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '4.15', 'spread': '2.16', 'groupId': 'OG001'}]}]}, {'title': 'Novel verb structure per utterance: post-treatment', 'categories': [{'measurements': [{'value': '5.94', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '4.61', 'spread': '1.78', 'groupId': 'OG001'}]}]}, {'title': 'Novel verb structures per utterance: 1-month follo', 'categories': [{'measurements': [{'value': '5.41', 'spread': '2.78', 'groupId': 'OG000'}, {'value': '4.16', 'spread': '2.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-treatment, post-treatment, 1-month follow-up', 'description': 'Samples were transcribed and segmented by utterance. Utterances were analyzed for novel verb structures. Structures were included if they were produced more than one time.', 'unitOfMeasure': 'Novel verb structures per utterance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Addressing Multiple Aspects of Language Simultaneously', 'description': 'Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.'}, {'id': 'FG001', 'title': 'Discrete Trial Approach', 'description': 'Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Change in emotional/behavioral status', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Children were recruited at three public school sites. From January 2009 to May 2010, 50 participants were successfully recruited. Of the 50, 40 met inclusion criteria and were randomly assigned to one of the two treatments.', 'preAssignmentDetails': 'No participants were excluded from the treatment following enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Addressing Multiple Aspects of Language Simultaneously', 'description': 'Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.'}, {'id': 'BG001', 'title': 'Discrete Trial Approach', 'description': 'Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.56', 'spread': '.50', 'groupId': 'BG000'}, {'value': '4.90', 'spread': '.51', 'groupId': 'BG001'}, {'value': '4.74', 'spread': '.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-14', 'studyFirstSubmitDate': '2009-02-09', 'resultsFirstSubmitDate': '2012-04-13', 'studyFirstSubmitQcDate': '2009-02-09', 'lastUpdatePostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-14', 'studyFirstPostDateStruct': {'date': '2009-02-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Language Sample Analysis', 'timeFrame': 'Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up.', 'description': 'Samples were transcribed and segmented by utterance. Each was coded categorically. Reported measures include percentage of utterances at the interpretive/inferential label, percentage of utterances with one or more t-unit (i.e., noun phrase + verb phrase), percentage of utterances that required copula (is/are) or auxiliary (is/are) that were produced.'}, {'measure': 'Number of Verb Structures Per Utterance', 'timeFrame': 'Pre-treatment, post-treatment, 1-month follow-up', 'description': 'Samples were transcribed and segmented by utterance. Utterances were analyzed for novel verb structures. Structures were included if they were produced more than one time.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Language Disorder']}, 'descriptionModule': {'briefSummary': "The goal of this proposal is to examine the efficacy of a manualized treatment intervention, AMALS: Addressing Multiple Aspects of Language Simultaneously, which is designed to remediate semantic, morphological, and syntactic aspects of language in preschool children with language impairment. This study will target preschool children with language impairment living in a region characterized by nonmainstream dialects.\n\nQuestions driving this work are:\n\n1. Will children participating in the AMALS treatment exhibit greater semantic, morphological, and syntactic complexity on multiple outcome measures at the completion of the intervention compared to a Discrete Trial Approach (DTA) group?\n2. Will these gains be maintained at one-month follow up?\n3. What is the impact of dialect on dependent variables, specifically morphosyntactic abilities?\n\nTo answer these questions a randomized clinical trial will be conducted comparing AMALS, an integrated approach to treatment, with DTA, an additive approach to therapy. In this study rather than restrict the ethnic and cultural backgrounds of this population, children's use of dialect will be uniquely identified and examined."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Demonstrate sufficient intelligibility as determined by a score of 85% on percent consonant correct (PCC) measures;\n2. Demonstrate sufficient phonological ability to use grammatical morphemes as determined by use of word-final /s, z, t, d/ on sound- in-word subtest from the Goldman-Fristoe Test of Articulation-2 (GFTA; Goldman \\& Fristoe, 2000)\n3. Nonverbal IQ above 70 as scored on the Columbia Mental Maturity Scale (CMMS; Burgemeister, Blum, \\& Lorge, 1972);\n4. Below 1SD on the Diagnostic Evaluation of Language Variation: Norm-referenced Test (DELV; Seymour, Roeper \\& de Villiers, 2005);\n5. Below 1.39SD on the Structured Photographic Expressive Language Test-Preschool (SPELT-P; Werner \\& Kresheck, 1983);\n6. Documentation from teachers and/or parents of impressions of language status in comparison with peers;\n7. More than one standard deviation below the mean on both levels 3 and 4 of the Preschool Language Assessment Instrument (PLAI; Blank, Rose, \\& Berlin, 1978).\n\nExclusion Criteria:\n\n1. English as the primary language\n2. No oral-motor impairment\n3. No hearing impairment\n4. No co-morbid psychiatric or neurological impairments'}, 'identificationModule': {'nctId': 'NCT00840060', 'acronym': 'AMALS', 'briefTitle': 'Efficacy of AMALS in Treating Language Impairment in Children', 'organization': {'class': 'OTHER', 'fullName': 'Lamar University'}, 'officialTitle': 'AMALS: Addressing Multiple Aspects of Language Simultaneously: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'RDC009027A-01A2'}, 'secondaryIdInfos': [{'id': '1R15DC009027-01A2', 'link': 'https://reporter.nih.gov/quickSearch/1R15DC009027-01A2', 'type': 'NIH'}, {'id': 'NIDCD RDC009027A-01A2'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMALS', 'description': 'Addressing multiple aspects of language simultaneously', 'interventionNames': ['Behavioral: AMALS']}, {'type': 'EXPERIMENTAL', 'label': 'DTA', 'description': 'Discrete Trial Approach', 'interventionNames': ['Behavioral: DTA']}], 'interventions': [{'name': 'AMALS', 'type': 'BEHAVIORAL', 'description': 'Addressing multiple aspects of language simultaneously', 'armGroupLabels': ['AMALS']}, {'name': 'DTA', 'type': 'BEHAVIORAL', 'description': 'Discrete Trial Approach', 'armGroupLabels': ['DTA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77631', 'city': 'Orange', 'state': 'Texas', 'country': 'United States', 'facility': 'West Orange Cove Consolidated Independent School District', 'geoPoint': {'lat': 30.09299, 'lon': -93.73655}}, {'zip': '77632', 'city': 'Orange', 'state': 'Texas', 'country': 'United States', 'facility': 'Little-Cypress Mauriceville Consolidated School District', 'geoPoint': {'lat': 30.09299, 'lon': -93.73655}}, {'zip': '77640', 'city': 'Port Arthur', 'state': 'Texas', 'country': 'United States', 'facility': 'Port Arthur Independent School District', 'geoPoint': {'lat': 29.88519, 'lon': -93.94233}}], 'overallOfficials': [{'name': 'Monica L Bellon-Harn, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lamar University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lamar University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Speech and Hearing Services', 'investigatorFullName': 'Monica L. Harn', 'investigatorAffiliation': 'Lamar University'}}}}