Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-01-01 @ 11:01 AM
Study NCT ID:
NCT03582566
Status:
COMPLETED
Last Update Posted:
2023-07-13
First Post:
2018-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Training Language and Literacy for Children Who Use CIs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Assessors are blind to treatment condition. Intervention providers are blind to assessment outcomes.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'The efficacy of phonological awareness (Earobics) and working memory (Cogmed) training alone and in combination are compared to an active control (Splashmath).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-12', 'studyFirstSubmitDate': '2018-06-18', 'studyFirstSubmitQcDate': '2018-06-27', 'lastUpdatePostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Phonological Awareness Test scores', 'timeFrame': 'Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline', 'description': 'Change in a standardized test of phonological awareness. Scores are from 0-100 with higher scores indicating better performance.'}, {'measure': 'Change inComprehensive Test of Phonological Awareness', 'timeFrame': 'Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline', 'description': 'Change in a standardized test of phonological awareness. Scores are from 0-100 with higher scores indicating better performance.'}, {'measure': "Change in Children's Test of Nonword Repetition", 'timeFrame': 'Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline', 'description': 'Change in a standardized test of verbal working memory'}], 'secondaryOutcomes': [{'measure': 'Change in Oral Written Language Scales', 'timeFrame': 'Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline', 'description': 'Change in a standardized test of language and literacy skills. Measures performance on expressive and receptive language, and reading and writing abilities. Scores are age-adjusted.'}, {'measure': 'Change in Receptive/Expressive One Word Picture Vocabulary Test', 'timeFrame': 'Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline', 'description': 'Change in a standardized test of vocabulary knowledge. Scores are from 0-100 with higher scores indicating better performance.'}, {'measure': 'Change in Woodcock Johnson Reading Mastery Test', 'timeFrame': 'Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline', 'description': 'Change in a standardized test of early literacy skills. Scores are from 0-100 with higher scores indicating better performance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss, Sensorineural']}, 'descriptionModule': {'briefSummary': 'This study aims to determine the effectiveness of computer games to improve language and literacy outcomes for children who have hearing loss. Children will be assigned to one of four conditions: phonological awareness training, working memory training, phonological awareness + working memory training, or active control.', 'detailedDescription': "Both phonological awareness and working memory are known to be important for children's language and literacy learning. Though there are computer games that claim to improve phonological awareness and working memory, it is unknown if these games will improve language and literacy skills for children who have hearing loss.\n\nThe investigators will first determine if the games are effective for improving language and phonological awareness in children with hearing loss relative to an active control condition. Secondly, the investigators will determine if gains in phonological awareness and working memory translate into gains in language and literacy skills relative to active control."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Prelingual hearing loss\n* Use of amplification device (hearing aid and/or cochlear implant) for at least one year\n* Able to visit the clinic 3x/week for 12 weeks\n\nExclusion Criteria:\n\n* No developmental delays (Down's syndrome, Autism spectrum disorder)"}, 'identificationModule': {'nctId': 'NCT03582566', 'briefTitle': 'Training Language and Literacy for Children Who Use CIs', 'organization': {'class': 'OTHER', 'fullName': 'Florida State University'}, 'officialTitle': 'Training-Induced Language and Literacy Improvement in Children With Cochlear Implants', 'orgStudyIdInfo': {'id': '037312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phonological Awareness', 'description': 'Children will play games to practice their rhyming, sound sequencing, and letter-sound knowledge. These games are all implemented in the Earobics program.', 'interventionNames': ['Behavioral: Phonological Awareness']}, {'type': 'EXPERIMENTAL', 'label': 'Working Memory', 'description': 'Children will play games designed to help them hold and manipulate objects in memory. These games are implemented in Cogmed.', 'interventionNames': ['Behavioral: Working Memory']}, {'type': 'EXPERIMENTAL', 'label': 'Phonological Awareness + Working Memory', 'description': 'Children will practice both their sound skills (Earobics) and their memory skills (Cogmed).', 'interventionNames': ['Behavioral: Phonological Awareness + Working Memory']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Control', 'description': 'Children will play games to practice their addition and subtraction skills (Splashmath).', 'interventionNames': ['Behavioral: Active Control']}], 'interventions': [{'name': 'Phonological Awareness', 'type': 'BEHAVIORAL', 'description': 'Earobics training', 'armGroupLabels': ['Phonological Awareness']}, {'name': 'Working Memory', 'type': 'BEHAVIORAL', 'description': 'Cogmed training', 'armGroupLabels': ['Working Memory']}, {'name': 'Phonological Awareness + Working Memory', 'type': 'BEHAVIORAL', 'description': 'Earobics + Cogmed training', 'armGroupLabels': ['Phonological Awareness + Working Memory']}, {'name': 'Active Control', 'type': 'BEHAVIORAL', 'description': 'Spashmath', 'armGroupLabels': ['Active Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32306', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida State University', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '60208', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}], 'overallOfficials': [{'name': 'Erin Ingvalson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northwestern University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'erin ingvalson', 'investigatorAffiliation': 'Florida State University'}}}}