Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT05445518
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-20
First Post:
2022-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Jump Start Plus COVID-19 Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2022-07-01', 'studyFirstSubmitQcDate': '2022-07-01', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Health Environment Rating Scale Scores', 'timeFrame': 'Baseline, Up to 3 years', 'description': 'The Health Environment Rating Scale has a total score ranging from 0 to 70 with higher scores indicating healthier practices'}, {'measure': 'Change in Strengths and Difficulties Questionnaire Scores', 'timeFrame': 'Baseline, Up to 3 years', 'description': 'The Strengths and Difficulties Questionnaire is a total difficulties score that ranges from 0 to 40 with higher scores indicating less child behavior concerns.'}, {'measure': 'Change in Devereux Early Childhood Assessments Scores', 'timeFrame': 'Baseline, Up to 3 years', 'description': 'The Devereux Early Childhood Assessments is a measure with a range of score from 0 to 100 with higher score on Behavior Concerns indicating more problem behaviors and a lower score on Initiative, Self-Control, Attachment indicated better protective factors.'}], 'secondaryOutcomes': [{'measure': 'Change in Brief Resilient Coping Scale Scores', 'timeFrame': 'Baseline, Up to 3 years', 'description': 'The Brief Resilient Coping Scale is a measure with a range of score from 4 to 20 with a higher score indicating better coping.'}, {'measure': 'Change in Childcare Worker Job Stress Index Scores', 'timeFrame': 'Baseline, Up to 3 years', 'description': 'The Childcare Worker Job Stress Index is a total score that ranges from 22 to 110 with higher scores indicating higher levels of stress'}, {'measure': 'Change in Every Day Stressors Index Scores', 'timeFrame': 'Baseline, Up to 3 years', 'description': 'The Every Day Stressors Index is a total score that ranges from 0 to 80 with higher scores indicating higher levels of stress.'}, {'measure': 'Change in Healthy Caregivers-Healthy Children Survey', 'timeFrame': 'Baseline, Up to 3 years', 'description': 'Teacher and parents complete this survey on the number of reported nutrition and physical activity practices'}, {'measure': 'Change in Teacher Opinion Survey', 'timeFrame': 'Baseline, up to 3 years', 'description': 'The Teacher Opinion survey is a measure with a range of score from 12 to 44 with higher score indicating better self-efficacy as it relates to teaching practices.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Health Wellness 1']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to further develop and examine the Jump Start Plus COVID Support (JS+CS) program, which encourages improved psychosocial functioning by promoting resiliency in childcare centers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Center Inclusion Criteria:\n\n1. Have greater than 30 children ages 2- to 5-years old\n2. Serve low-income families\n3. Reflect the ethnic diversity of Miami-Dade County (60%Hispanic, 20% Non-Hispanic Black, 20% Non-Hispanic White\n\nChild Inclusion Criteria:\n\n1. Child ages 2-5 years old\n2. Child enrolled in a childcare center\n\nExclusion Criteria:\n\n* Children with feeding tubes or those that bring their own meals.'}, 'identificationModule': {'nctId': 'NCT05445518', 'briefTitle': 'Jump Start Plus COVID-19 Support', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Jump Start Plus: Coronavirus Disease (COVID-19) Support to Improve Resiliency and Mitigate Risks in Childcare Centers Serving Children From Low-income Ethnic Minority Backgrounds.', 'orgStudyIdInfo': {'id': '20220115'}, 'secondaryIdInfos': [{'id': 'R01HD105474', 'link': 'https://reporter.nih.gov/quickSearch/R01HD105474', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Jump Start Plus COVID Support (JS+CS) Group', 'description': 'Participants in this group will receive the Jump Start Plus COVID Support intervention for 24 months.', 'interventionNames': ['Behavioral: Jump Start Plus COVID Support']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Caregivers-Healthy Children (HC2) Control Group', 'description': 'Participants in this group will receive the Healthy Caregivers-Healthy Children intervention for 24 months.', 'interventionNames': ['Behavioral: Healthy Caregivers-Healthy Children (HC2)']}], 'interventions': [{'name': 'Jump Start Plus COVID Support', 'type': 'BEHAVIORAL', 'description': 'The Jump Start Plus COVID Support intervention is a resiliency program that provides behavior management and safety programs administered weekly via zoom.', 'armGroupLabels': ['Jump Start Plus COVID Support (JS+CS) Group']}, {'name': 'Healthy Caregivers-Healthy Children (HC2)', 'type': 'BEHAVIORAL', 'description': 'The HC2 intervention is an obesity prevention program that provides nutrition and healthy activities programs administered weekly via Zoom.', 'armGroupLabels': ['Healthy Caregivers-Healthy Children (HC2) Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33146', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Ruby Natale', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Clinical Pediatrics', 'investigatorFullName': 'Ruby Natale', 'investigatorAffiliation': 'University of Miami'}}}}