Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-01-01 @ 4:19 PM
Study NCT ID:
NCT01405404
Status:
COMPLETED
Last Update Posted:
2013-05-07
First Post:
2011-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Engaging Low-Income Families in Prevention Programs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-06', 'studyFirstSubmitDate': '2011-07-21', 'studyFirstSubmitQcDate': '2011-07-28', 'lastUpdatePostDateStruct': {'date': '2013-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in child behavior problems', 'timeFrame': 'baseline, 3-months, 9-months, 15-months', 'description': 'Change from baseline to 15 months later on three measures of child behavior problems are used: parent-report (CBCL), teacher-report (CTRF), and observer rating (DPICS)'}], 'secondaryOutcomes': [{'measure': 'Changing in parenting behavior', 'timeFrame': 'baseline, 3-months, 9-months, 15-months', 'description': 'change from baseline to 15 months later on parent-report measures(parenting self-efficacy, use of corporal punishment) and observer ratings of parent behavior (use of praise, critical statements, commands, physical negative behaviors, physical positive behaviors) are evaluated'}, {'measure': 'Participation rate', 'timeFrame': 'baseline and 3 months', 'description': 'Enrollment rate is measured at baseline, and number of intervention sessions attended and degree to which parents were actively engaged in the intervention sessions are measured 3 months later at post-intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['parenting childcare discounts child behavior', 'No Intervention Control', 'Intervention no childcare discount', 'Intervention with childcare discount'], 'conditions': ['Parenting']}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to (1) study the cost-effectiveness of childcare discounts on increasing parent participation rates in a preventive parent training program called the Chicago Parent Program and (2) evaluate the efficacy of the Spanish-translated version of the Chicago Parent Program in childcare centers serving low-income families with young children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* parent of 2-4 year old child enrolled in participating day care center\n\nExclusion Criteria:\n\n* parent previously participated in parent training program'}, 'identificationModule': {'nctId': 'NCT01405404', 'briefTitle': 'Engaging Low-Income Families in Prevention Programs', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Engaging Low-Income Families in Prevention Programs', 'orgStudyIdInfo': {'id': 'L05031502'}, 'secondaryIdInfos': [{'id': 'R01NR004085', 'link': 'https://reporter.nih.gov/quickSearch/R01NR004085', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No intervention control', 'description': 'Parents complete surveys only'}, {'type': 'EXPERIMENTAL', 'label': 'parent training but no discount', 'description': 'parent enrolled in the parent training intervention but do not receive childcare discounts for attending', 'interventionNames': ['Behavioral: Parent Training and childcare discount']}, {'type': 'EXPERIMENTAL', 'label': 'Parent training with discount', 'description': 'parents receive parent training and a childcare discount for attending', 'interventionNames': ['Other: Parent Training']}], 'interventions': [{'name': 'Parent Training and childcare discount', 'type': 'BEHAVIORAL', 'otherNames': ['Chicago Parent Program'], 'description': '12-session parent training intervention called the Chicago Parent Program; Childcare discount given in one arm to examine its effect on attendance rate', 'armGroupLabels': ['parent training but no discount']}, {'name': 'Parent Training', 'type': 'OTHER', 'otherNames': ['Chicago Parent Program'], 'description': '12-session group on parenting skills and child behavior management', 'armGroupLabels': ['Parent training with discount']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Deborah A Gross, DNSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Deborah Gross', 'investigatorAffiliation': 'Rush University Medical Center'}}}}