Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-02-10 @ 2:20 AM
Study NCT ID:
NCT06512168
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2024-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measuring Aided Language Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D001072', 'term': 'Apraxias'}, {'id': 'D066229', 'term': 'Speech Sound Disorder'}, {'id': 'D013060', 'term': 'Speech'}, {'id': 'D007806', 'term': 'Language Disorders'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014705', 'term': 'Verbal Behavior'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2024-07-16', 'studyFirstSubmitQcDate': '2024-07-16', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aided AAC Utterance Length', 'timeFrame': '24 Months', 'description': 'Aided AAC Sentence Length Measured in Morphemes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Augmentative and Alternative Communication', 'Complex Communication Needs', 'Assistive Technology', 'AAC'], 'conditions': ['Down Syndrome', 'Cerebral Palsy', 'Apraxia of Speech', 'Speech Sound Disorder', 'Speech Disorders in Children', 'Speech and Language Disorder']}, 'descriptionModule': {'briefSummary': 'The focus of the current study is to systematically investigate the psychometric properties of a range of aided language measures, which are based on the Graphic Symbol Utterance and Sentence Development Framework (Binger \\& Kent-Walsh).', 'detailedDescription': 'Our central hypotheses are: (1) psychometrically sound measures can be established to capture growth within and across different dimensions of language acquisition, and (2) some elicitation contexts will be better than others at capturing aided language growth. Specific Aim 1 identifies valid measures to characterize aided language progress. Aim 1A uses existing data to document the psychometric properties of a range of aided language measures for preschoolers at the early stages of aided communication acquisition who have received 4 months of aided language intervention. Aim 1B analyzes language progression for high-performing aided communicators who will receive 24 months of intervention; this allows for investigation across all phases of early aided language acquisition. Specific Aim 2 identifies elicitation contexts that demonstrate the most productive aided language use. Achievement of the aims will result in measures that demonstrate strong reliability, differentiate growth for different populations, describe different dimensions of language growth, and are clinically feasible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Months', 'minimumAge': '42 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical Identification of Down Syndrome or Cerebral Palsy + Significant Speech Impairment\n* Must Speak English as a Primary Language\n* Must Be Able to Express At Least 25 Words (using any communication mode)\n* Must Be Able to Accurately Select Picture Symbols on iPad Communication App with at Least 50% Accuracy\n* Vision and Hearing within Functional Limits or Corrected to be within Functional Limits for Study Activities\n\nExclusion Criteria:\n\n* Clinical Diagnosis of Autism or Social Communication Disorder\n* Primary Language Spoken is A Language Other than English'}, 'identificationModule': {'nctId': 'NCT06512168', 'acronym': 'MALD', 'briefTitle': 'Measuring Aided Language Development', 'organization': {'class': 'OTHER', 'fullName': 'University of Central Florida'}, 'officialTitle': 'Measuring Aided Language Development', 'orgStudyIdInfo': {'id': 'AWD00006137'}, 'secondaryIdInfos': [{'id': '1R01DC021160-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DC021160-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'AAC Generative Language Intervention', 'interventionNames': ['Behavioral: AAC Generative Language Intervention']}], 'interventions': [{'name': 'AAC Generative Language Intervention', 'type': 'BEHAVIORAL', 'description': 'Aided AAC Language Input/Output Intervention', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32826', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nancy Harrington, MA', 'role': 'CONTACT', 'email': 'nancy.harrington@ucf.edu', 'phone': '(407) 882-0465'}], 'facility': 'University of Central Florida - Innovative Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'centralContacts': [{'name': 'Jennifer Kent-Walsh, PhD', 'role': 'CONTACT', 'email': 'Jkentwalsh@ucf.edu', 'phone': '407-823-4800'}, {'name': 'Cathy Binger, PhD', 'role': 'CONTACT', 'email': 'cbinger@unm.edu', 'phone': '505-277-4453'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'NICHD Data and Specimen Hub'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Central Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}, {'name': 'University of New Mexico', 'class': 'OTHER'}, {'name': 'University of Wisconsin, Milwaukee', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pegasus Professor & Associate Dean of Research', 'investigatorFullName': 'Jennifer Kent-Walsh', 'investigatorAffiliation': 'University of Central Florida'}}}}