{ "FullStudy":{ "Rank":217708, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517867", "OrgStudyIdInfo":{ "OrgStudyId":"NA_00039328" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"R01NR012444", "SecondaryIdType":"U.S. NIH Grant/Contract", "SecondaryIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=R01NR012444&Fy=all" } ] }, "Organization":{ "OrgFullName":"Johns Hopkins University", "OrgClass":"OTHER" }, "BriefTitle":"Early Parenting Intervention Comparison", "OfficialTitle":"Comparing Two Parenting Programs for At-Risk Families", "Acronym":"EPIC" }, "StatusModule":{ "StatusVerifiedDate":"April 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"September 2011", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 2017", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 2017", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 23, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"February 27, 2018", "ResultsFirstSubmitQCDate":"February 27, 2018", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"April 2, 2018", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"April 3, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 3, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Johns Hopkins University", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Hugo W. Moser Research Institute at Kennedy Krieger, Inc.", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"University of Iowa", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"National Institute of Nursing Research (NINR)", "CollaboratorClass":"NIH" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "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." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Behavior Problems, Child" ] }, "KeywordList":{ "Keyword":[ "preschool children behavior problems", "child between 2 and 5 years old" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"161", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Intervention Chicago Parent Program arm", "ArmGroupType":"Experimental", "ArmGroupDescription":"The Chicago Parent Program is a 12-session group-based parenting skills training program", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Chicago Parent Program" ] } },{ "ArmGroupLabel":"Parent-Child Interaction Therapy", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Parent-Child Interaction Therapy" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Behavioral", "InterventionName":"Chicago Parent Program", "InterventionDescription":"The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Intervention Chicago Parent Program arm" ] } },{ "InterventionType":"Behavioral", "InterventionName":"Parent-Child Interaction Therapy", "InterventionDescription":"Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Parent-Child Interaction Therapy" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change in Child Behavior Problems", "PrimaryOutcomeDescription":"parent-report measure called The Child Behavior Checklist. Raw scores range from 0 to 198 with lower numbers being better for the child.", "PrimaryOutcomeTimeFrame":"baseline, first follow-up (up to 2 years)" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Aggregate Cost", "SecondaryOutcomeDescription":"Combined provider (based on billing records) and parent cost (based on self-report).", "SecondaryOutcomeTimeFrame":"through end of study (up to 2 years)" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nchild 2 to 5 years old\nparent reports reason for referral is child behavior problems\nparent is a biological or adoptive parent, or legal guardian of child\n\nExclusion Criteria:\n\nparent is psychotic or actively abusing substances\nchild is autistic or severely developmentally delayed", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"2 Years", "MaximumAge":"5 Years", "StdAgeList":{ "StdAge":[ "Child" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Deborah Gross, DNSc", "OverallOfficialAffiliation":"Johns Hopkins University, School of Nursing", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"The Family Center at Kennedy Krieger Institute", "LocationCity":"Baltimore", "LocationState":"Maryland", "LocationZip":"21205", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"30768419", "ReferenceType":"derived", "ReferenceCitation":"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." },{ "ReferencePMID":"24581245", "ReferenceType":"derived", "ReferenceCitation":"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." } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"No", "IPDSharingDescription":"No data sharing plan was developed." } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Intervention Chicago Parent Program Arm", "FlowGroupDescription":"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" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Parent-Child Interaction Therapy", "FlowGroupDescription":"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" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"81" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"80" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"18" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"15" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"63" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"65" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"never started treatment", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"29" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"32" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"34" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"30" } ] } },{ "FlowDropWithdrawType":"Still in treatment at study end", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"3" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Intervention Chicago Parent Program Arm", "BaselineGroupDescription":"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" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Parent-Child Interaction Therapy", "BaselineGroupDescription":"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" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"81" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"80" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"161" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"33.0", "BaselineMeasurementLowerLimit":"22", "BaselineMeasurementUpperLimit":"69" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"34.5", "BaselineMeasurementLowerLimit":"22", "BaselineMeasurementUpperLimit":"71" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"33.76", "BaselineMeasurementLowerLimit":"22", "BaselineMeasurementUpperLimit":"71" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"73" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"75" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"148" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"13" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Ethnicity (NIH/OMB)", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Hispanic or Latino", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"7" } ] } },{ "BaselineCategoryTitle":"Not Hispanic or Latino", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"76" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"78" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"154" } ] } },{ "BaselineCategoryTitle":"Unknown or Not Reported", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race (NIH/OMB)", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"American Indian or Alaska Native", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } },{ "BaselineCategoryTitle":"Asian", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } },{ "BaselineCategoryTitle":"Native Hawaiian or Other Pacific Islander", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Black or African American", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"55" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"59" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"114" } ] } },{ "BaselineCategoryTitle":"White", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"18" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"34" } ] } },{ "BaselineCategoryTitle":"More than one race", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"11" } ] } },{ "BaselineCategoryTitle":"Unknown or Not Reported", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"81" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"80" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"161" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change in Child Behavior Problems", "OutcomeMeasureDescription":"parent-report measure called The Child Behavior Checklist. Raw scores range from 0 to 198 with lower numbers being better for the child.", "OutcomeMeasurePopulationDescription":"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.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"baseline, first follow-up (up to 2 years)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Intervention Chicago Parent Program Arm", "OutcomeGroupDescription":"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" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Parent-Child Interaction Therapy", "OutcomeGroupDescription":"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" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"42" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"34" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"67.0", "OutcomeMeasurementSpread":"13.42" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"67.6", "OutcomeMeasurementSpread":"11.75" } ] } } ] } },{ "OutcomeClassTitle":"first follow-up (up to 2 years)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"60.4", "OutcomeMeasurementSpread":"12.92" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"59.9", "OutcomeMeasurementSpread":"13.34" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Aggregate Cost", "OutcomeMeasureDescription":"Combined provider (based on billing records) and parent cost (based on self-report).", "OutcomeMeasurePopulationDescription":"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.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"dollars", "OutcomeMeasureTimeFrame":"through end of study (up to 2 years)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Intervention Chicago Parent Program Arm", "OutcomeGroupDescription":"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" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Parent-Child Interaction Therapy", "OutcomeGroupDescription":"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" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"42" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"34" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1413", "OutcomeMeasurementSpread":"1211" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2151", "OutcomeMeasurementSpread":"2583" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsTimeFrame":"from the start of treatment until discharge (up to approximately 2 years)", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Intervention Chicago Parent Program Arm", "EventGroupDescription":"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", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"81", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"81", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"81" },{ "EventGroupId":"EG001", "EventGroupTitle":"Parent-Child Interaction Therapy", "EventGroupDescription":"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", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"80", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"80", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"80" } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"Yes" }, "PointOfContact":{ "PointOfContactTitle":"Deborah Gross", "PointOfContactOrganization":"Johns Hopkins University", "PointOfContactEMail":"debgross@jhu.edu", "PointOfContactPhone":"410-614-5311" } } }, "DocumentSection":{ "LargeDocumentModule":{ "LargeDocList":{ "LargeDoc":[ { "LargeDocTypeAbbrev":"Prot_SAP", "LargeDocHasProtocol":"Yes", "LargeDocHasSAP":"Yes", "LargeDocHasICF":"No", "LargeDocLabel":"Study Protocol and Statistical Analysis Plan", "LargeDocDate":"January 30, 2012", "LargeDocUploadDate":"02/26/2018 09:59", "LargeDocFilename":"Prot_SAP_000.pdf" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000066553", "ConditionMeshTerm":"Problem Behavior" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000001526", "ConditionAncestorTerm":"Behavioral Symptoms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M85", "ConditionBrowseLeafName":"Problem Behavior", "ConditionBrowseLeafAsFound":"Behavior Problems", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3399", "ConditionBrowseLeafName":"Behavioral Symptoms", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BXM", "ConditionBrowseBranchName":"Behaviors and Mental Disorders" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }