Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-01-25 @ 3:36 AM
Study NCT ID:
NCT01963468
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2013-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maximizing Language Development in Children With Hearing Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-27', 'studyFirstSubmitDate': '2013-10-11', 'studyFirstSubmitQcDate': '2013-10-11', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Communication and Symbolic Behavior Scales', 'timeFrame': '6 months'}], 'primaryOutcomes': [{'measure': 'MacArthur Communicative Development Inventories', 'timeFrame': 'one month'}], 'secondaryOutcomes': [{'measure': 'Preschool Language Scale', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hearing Loss', 'Cochlear Implant', 'Deaf', 'Hearing Impairment', 'Hard of Hearing'], 'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of early intervention on language skills for children with hearing loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6 to 18 months of age\n* bilateral, moderate to profound congenital hearing loss\n\nExclusion Criteria:\n\n* auditory neuropathy\n* no known additional disabilities (e.g., cerebral palsy, Down syndrome)\n* both parents have a severe to profound hearing loss'}, 'identificationModule': {'nctId': 'NCT01963468', 'briefTitle': 'Maximizing Language Development in Children With Hearing Loss', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Pre-Implantation Communication Treatment for Children With Hearing Loss', 'orgStudyIdInfo': {'id': 'STU00081066'}, 'secondaryIdInfos': [{'id': '1R03DC012639', 'link': 'https://reporter.nih.gov/quickSearch/1R03DC012639', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early language intervention', 'description': 'Children will receive 6 months of weekly parent-implemented intervention sessions.\n\nChildren will be assessed monthly via audio recordings and language checklists to monitor language development more closely.', 'interventionNames': ['Behavioral: Early language intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Monthly language check-ups', 'description': 'Children will be assessed monthly via home observations and parents will complete a language checklist to monitor language development more closely.'}], 'interventions': [{'name': 'Early language intervention', 'type': 'BEHAVIORAL', 'description': "Parents will practice the specific set of strategies (visual, interactive, tactile, responsive) during sessions that occur weekly and last 1 hour for a total of 26 sessions, over 6 months. Each session will include four segments: (a) the therapist will review the intervention strategies taught in the workshop (10 min), (b) the therapist will model the intervention strategy with the child (10 min), (c) the parent will practice the strategy with her child with coaching from the therapist across four different routines and activities of the parent's choice (30 min), and (d) the therapist will provide feedback to the parent, summarize the session, and answer the parent's questions (10 min).", 'armGroupLabels': ['Early language intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60202', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}], 'overallOfficials': [{'name': 'Megan Y Roberts, PhD, CCC-SLP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Megan Roberts', 'investigatorAffiliation': 'Northwestern University'}}}}