Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT04988451
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-11
First Post:
2021-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Family ASL: Longitudinal Study of Deaf Children and Hearing Parents Who Receive Services to Support the Learning of ASL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003638', 'term': 'Deafness'}, {'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D007802', 'term': 'Language'}, {'id': 'D012813', 'term': 'Sign Language'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'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': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D008369', 'term': 'Manual Communication'}, {'id': 'D009633', 'term': 'Nonverbal Communication'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Case Design - interrupted time series. Participants will receive intervention in 6-week on/off blocks. Measurements are taken in both on and off weeks.\n\nThe Bayesian procedure developed by Swaminathan et al. (2014) involves fitting piece-wise linear or curvilinear trends across the phases, modeling dependencies in the observations with a suitably chosen autoregressive error scheme, and using the Markov Chain Monte Carlo (MCMC) method to obtain the posterior distributions of the model parameters and effect size measures'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2021-07-26', 'studyFirstSubmitQcDate': '2021-07-26', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in ASL Phonological Production Accuracy over 12 Months', 'timeFrame': 'Baseline and 12 months', 'description': 'Participants copy ASL signs produced on video; their productions are scored for phonological accuracy and reported as percent correct out of all possible phonological features. Weekly measures are taken for SCD analysis.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in ASL Production Frequency over 12 Months', 'timeFrame': 'Baseline and 12 months', 'description': 'Participants engage in naturalistic play sessions which are videorecorded. Sessions are analyzed for the number of productions in ASL over a 15-minute period. Weekly measures are taken for SCD analysis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['language', 'sign language', 'language development', 'child language', 'child, preschool', 'parents', 'caregivers'], 'conditions': ['Deafness', 'Hearing Loss']}, 'descriptionModule': {'briefSummary': 'This study examines the development of American Sign Language by deaf and hard of hearing (DHH) children and their parents.', 'detailedDescription': 'After being informed about the study and potential risks, adult participants who give written informed consent and children whose parents who give written permission will be enrolled in the study. They will participate in preliminary language tasks to assess baseline performance on American Sign Language (ASL) measures. Subsequently they will have weekly sessions with an ASL Specialist to support their development of ASL, following a 6-week on/6-week off ABABABAB sequence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren:\n\n* Children ages 2;00 - 2;11 at the start of the longitudinal project\n* Child is Deaf/ Hard-of-Hearing\n* Participating in a program utilizing a bimodal bilingual philosophy\n\nAdults:\n\n\\- One adult caregiver for each child\n\nExclusion Criteria:\n\n* Children with previously-diagnosed conditions other than deafness known to affect language and cognitive development\n* Families without access to internet (at home or other locations)'}, 'identificationModule': {'nctId': 'NCT04988451', 'acronym': 'FASL', 'briefTitle': 'Family ASL: Longitudinal Study of Deaf Children and Hearing Parents Who Receive Services to Support the Learning of ASL', 'organization': {'class': 'OTHER', 'fullName': 'University of Connecticut'}, 'officialTitle': 'Family ASL: Longitudinal Study of Deaf Children and Hearing Parents Who Receive Services to Support the Learning of American Sign Language (ASL)', 'orgStudyIdInfo': {'id': 'H20-0037'}, 'secondaryIdInfos': [{'id': 'R01DC016901', 'link': 'https://reporter.nih.gov/quickSearch/R01DC016901', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASL Services - Adult ASL Development', 'description': 'Presence (or absence, across 6-week periods) of ASL services designed to support improvement in ASL fluency', 'interventionNames': ['Behavioral: ASL Services']}, {'type': 'EXPERIMENTAL', 'label': 'ASL Services - Child Language Development', 'description': 'Presence (or absence, across 6-week periods) of ASL services designed to support improvement in ASL fluency', 'interventionNames': ['Behavioral: ASL Services']}], 'interventions': [{'name': 'ASL Services', 'type': 'BEHAVIORAL', 'description': 'ASL specialist meets with participants and provides ASL instruction', 'armGroupLabels': ['ASL Services - Adult ASL Development', 'ASL Services - Child Language Development']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06268', 'city': 'Storrs', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Connecticut - Department of Linguistics', 'geoPoint': {'lat': 41.80843, 'lon': -72.24952}}], 'overallOfficials': [{'name': 'Diane C Lillo-Martin, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Connecticut'}]}, 'ipdSharingStatementModule': {'timeFrame': 'After (or with) publication of the results', 'ipdSharing': 'YES', 'description': 'De-identified data from language tasks', 'accessCriteria': 'De-identified numerical coding scores will be shared using an open science site that is generally accessible'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Connecticut', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'BOT Distinguished Professor', 'investigatorFullName': 'Diane Lillo-Martin', 'investigatorAffiliation': 'University of Connecticut'}}}}