Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-30 @ 12:17 PM
Study NCT ID:
NCT01517867
Status:
COMPLETED
Last Update Posted:
2018-05-03
First Post:
2012-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Early Parenting Intervention Comparison
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'debgross@jhu.edu', 'phone': '410-614-5311', 'title': 'Deborah Gross', 'organization': 'Johns Hopkins University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'from the start of treatment until discharge (up to approximately 2 years)', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Chicago Parent Program Arm', 'description': 'The Chicago Parent Program is a 12-session group-based parenting skills training program\n\nChicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 0, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Parent-Child Interaction Therapy', 'description': 'Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems\n\nParent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Child Behavior Problems', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Chicago Parent Program Arm', 'description': 'The Chicago Parent Program is a 12-session group-based parenting skills training program\n\nChicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems'}, {'id': 'OG001', 'title': 'Parent-Child Interaction Therapy', 'description': 'Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems\n\nParent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '67.0', 'spread': '13.42', 'groupId': 'OG000'}, {'value': '67.6', 'spread': '11.75', 'groupId': 'OG001'}]}]}, {'title': 'first follow-up (up to 2 years)', 'categories': [{'measurements': [{'value': '60.4', 'spread': '12.92', 'groupId': 'OG000'}, {'value': '59.9', 'spread': '13.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, first follow-up (up to 2 years)', 'description': 'parent-report measure called The Child Behavior Checklist. Raw scores range from 0 to 198 with lower numbers being better for the child.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'First follow-up data collected from 42 participants in Chicago Parent Program and 34 participants in Parent-Child Interaction Therapy who started treatment and were discharged, regardless of whether they completed the full treatment. Did not collect follow-up data from remaining participants who enrolled in study but never attended any treatment.'}, {'type': 'SECONDARY', 'title': 'Aggregate Cost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Chicago Parent Program Arm', 'description': 'The Chicago Parent Program is a 12-session group-based parenting skills training program\n\nChicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems'}, {'id': 'OG001', 'title': 'Parent-Child Interaction Therapy', 'description': 'Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems\n\nParent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems'}], 'classes': [{'categories': [{'measurements': [{'value': '1413', 'spread': '1211', 'groupId': 'OG000'}, {'value': '2151', 'spread': '2583', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through end of study (up to 2 years)', 'description': 'Combined provider (based on billing records) and parent cost (based on self-report).', 'unitOfMeasure': 'dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cost collected for 42 participants in Chicago Parent Program and 34 participants in Parent-Child Interaction Therapy who started treatment and were discharged, regardless of whether they completed the full treatment. Did not collect cost data from the remaining participants who enrolled in study but never attended any treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Chicago Parent Program Arm', 'description': 'The Chicago Parent Program is a 12-session group-based parenting skills training program\n\nChicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems'}, {'id': 'FG001', 'title': 'Parent-Child Interaction Therapy', 'description': 'Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems\n\nParent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '65'}]}], 'dropWithdraws': [{'type': 'never started treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Still in treatment at study end', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Chicago Parent Program Arm', 'description': 'The Chicago Parent Program is a 12-session group-based parenting skills training program\n\nChicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems'}, {'id': 'BG001', 'title': 'Parent-Child Interaction Therapy', 'description': 'Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems\n\nParent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.0', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '69'}, {'value': '34.5', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '71'}, {'value': '33.76', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '71'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-01-30', 'size': 380617, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-02-26T09:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-03', 'studyFirstSubmitDate': '2012-01-23', 'resultsFirstSubmitDate': '2018-02-27', 'studyFirstSubmitQcDate': '2012-01-24', 'lastUpdatePostDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-27', 'studyFirstPostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Child Behavior Problems', 'timeFrame': 'baseline, first follow-up (up to 2 years)', 'description': 'parent-report measure called The Child Behavior Checklist. Raw scores range from 0 to 198 with lower numbers being better for the child.'}], 'secondaryOutcomes': [{'measure': 'Aggregate Cost', 'timeFrame': 'through end of study (up to 2 years)', 'description': 'Combined provider (based on billing records) and parent cost (based on self-report).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['preschool children behavior problems', 'child between 2 and 5 years old'], 'conditions': ['Behavior Problems, Child']}, 'referencesModule': {'references': [{'pmid': '30768419', 'type': 'DERIVED', 'citation': 'Gross D, Belcher HME, Budhathoki C, Ofonedu ME, Dutrow D, Uveges MK, Slade E. Reducing Preschool Behavior Problems in an Urban Mental Health Clinic: A Pragmatic, Non-Inferiority Trial. J Am Acad Child Adolesc Psychiatry. 2019 Jun;58(6):572-581.e1. doi: 10.1016/j.jaac.2018.08.013. Epub 2018 Nov 12.'}, {'pmid': '24581245', 'type': 'DERIVED', 'citation': 'Gross DA, Belcher HM, Ofonedu ME, Breitenstein S, Frick KD, Chakra B. Study protocol for a comparative effectiveness trial of two parent training programs in a fee-for-service mental health clinic: can we improve mental health services to low-income families? Trials. 2014 Mar 1;15:70. doi: 10.1186/1745-6215-15-70.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effectiveness of two parenting programs in a mental health clinic serving young children with behavior problems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* child 2 to 5 years old\n* parent reports reason for referral is child behavior problems\n* parent is a biological or adoptive parent, or legal guardian of child\n\nExclusion Criteria:\n\n* parent is psychotic or actively abusing substances\n* child is autistic or severely developmentally delayed'}, 'identificationModule': {'nctId': 'NCT01517867', 'acronym': 'EPIC', 'briefTitle': 'Early Parenting Intervention Comparison', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Comparing Two Parenting Programs for At-Risk Families', 'orgStudyIdInfo': {'id': 'NA_00039328'}, 'secondaryIdInfos': [{'id': 'R01NR012444', 'link': 'https://reporter.nih.gov/quickSearch/R01NR012444', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Chicago Parent Program arm', 'description': 'The Chicago Parent Program is a 12-session group-based parenting skills training program', 'interventionNames': ['Behavioral: Chicago Parent Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Parent-Child Interaction Therapy', 'description': 'Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems', 'interventionNames': ['Behavioral: Parent-Child Interaction Therapy']}], 'interventions': [{'name': 'Chicago Parent Program', 'type': 'BEHAVIORAL', 'description': 'The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems', 'armGroupLabels': ['Intervention Chicago Parent Program arm']}, {'name': 'Parent-Child Interaction Therapy', 'type': 'BEHAVIORAL', 'description': 'Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems', 'armGroupLabels': ['Parent-Child Interaction Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Family Center at Kennedy Krieger Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Deborah Gross, DNSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University, School of Nursing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No data sharing plan was developed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hugo W. Moser Research Institute at Kennedy Krieger, Inc.', 'class': 'OTHER'}, {'name': 'University of Iowa', 'class': 'OTHER'}, {'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}