Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-01-06 @ 2:34 PM
Study NCT ID:
NCT04423133
Status:
COMPLETED
Last Update Posted:
2020-09-29
First Post:
2020-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bilingual Family Literacy Program Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067010', 'term': 'Literacy'}, {'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-25', 'studyFirstSubmitDate': '2020-06-03', 'studyFirstSubmitQcDate': '2020-06-05', 'lastUpdatePostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of sessions attended by participants', 'timeFrame': '8 weeks', 'description': 'Data on the number of sessions attended by participants will be used to assess the feasibility of the online family literacy program.'}, {'measure': 'Acceptability of the program', 'timeFrame': '8 weeks', 'description': 'Data on acceptability of the program will be collected via parent surveys'}], 'secondaryOutcomes': [{'measure': 'StimQ Reading Scale', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Reading activity will be measured using the StimQ Reading Scale. The StimQ is a structured interview. Individual items are summed and scores range from 0 to 19. Higher scores reflect higher reading activities.'}, {'measure': 'StimQ Parental Verbal Responsivity Scale', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Parent verbal responsiveness will be measured using the StimQ Parental Verbal Responsivity Scale. The StimQ is a structured interview. Individual items are summed and scores range from 0 to 7. Higher scores reflect higher parent verbal responsiveness.'}, {'measure': 'Child Literacy Skills', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Investigator developed assessments of child alphabet knowledge and sight word recognition. Higher scores reflect higher literacy skills.'}, {'measure': 'Family Health Routines Assessment', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Descriptive survey measuring family health routines and behaviors.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Language development', 'Health routines', 'Literacy'], 'conditions': ['Language Development', 'Literacy', 'Health Behavior']}, 'descriptionModule': {'briefSummary': 'This study will examine the feasibility of implementing a virtual bilingual health-focused family literacy program.', 'detailedDescription': '"Ready and Healthy for Kindergarten" is a bilingual family literacy program that uses anticipatory guidance on important health routines to introduce critical language and literacy skills to young Latino children entering Kindergarten and their families.\n\nThe objectives of this study are 1) To assess the feasibility of implementing the bilingual family literacy program online via video conference by collecting information on family attendance and participation, 2) To examine the acceptability of the program, and 3) To explore preliminary effects of the program on the family health and language routines as well as child language and literacy skill acquisition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preferred language either Spanish or bilingual (English and Spanish)\n* Parent or legal guardian of the child\n* Parent Age ≥ 18\n\nExclusion Criteria:\n\n* Children not entering Kindergarten.'}, 'identificationModule': {'nctId': 'NCT04423133', 'briefTitle': 'Bilingual Family Literacy Program Pilot', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Bilingual Family Literacy Program Pilot: Ready and Healthy for Kindergarten', 'orgStudyIdInfo': {'id': 'Pro2020000656'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Online Family Literacy Program', 'description': 'The Ready and Healthy for Kindergarten program is a bilingual family literacy program that uses anticipatory guidance on health routines (e.g., physical activity) to introduce language and literacy skills to children and their families delivered via an online video conference format.', 'interventionNames': ['Behavioral: Online Family Literacy Program']}], 'interventions': [{'name': 'Online Family Literacy Program', 'type': 'BEHAVIORAL', 'description': "Parent-child dyads will participate in 8 weekly online health-themed workshops that introduce language and literacy skills. Participants will also receive 2-3 text messages per week for the duration of the program and children's books.", 'armGroupLabels': ['Online Family Literacy Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Child Health Institute of NJ', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Manuel E Jimenez, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers Biomedical Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Manuel E. Jimenez, MD, MS', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}