{ "FullStudy":{ "Rank":217857, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515930", "OrgStudyIdInfo":{ "OrgStudyId":"3M's Diabetes Study" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"R21DK089238", "SecondaryIdType":"U.S. NIH Grant/Contract", "SecondaryIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=R21DK089238&Fy=all" } ] }, "Organization":{ "OrgFullName":"Wayne State University", "OrgClass":"OTHER" }, "BriefTitle":"Computerized Intervention of Parental Involvement in Diabetes Care of Their Child", "OfficialTitle":"Computer-Delivered Motivational Intervention to Improve Teen Diabetes Management" }, "StatusModule":{ "StatusVerifiedDate":"June 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"April 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"March 3, 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 9, 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"June 1, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"June 2, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Deborah Ellis, Ph.D.", "ResponsiblePartyInvestigatorTitle":"Associate Professor", "ResponsiblePartyInvestigatorAffiliation":"Wayne State University" }, "LeadSponsor":{ "LeadSponsorName":"Wayne State University", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)", "CollaboratorClass":"NIH" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes", "IsFDARegulatedDrug":"No", "IsFDARegulatedDevice":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to develop an intervention to increase parental motivation for supervision and monitoring youth diabetes care behavior. The intervention will be tested in three brief session in conjunction with regularly scheduled diabetes clinic visits and delivered through a computer program based in the principles of Motivational Interviewing.", "DetailedDescription":"The study includes a development phase (Phase 1: development of the intervention followed by feasibility testing with 10 youth and 10 parents) and a pilot validation phase [Phase 2: pilot randomized clinical trial (RCT)] using a sample of 90 African American youth transitioning to independent diabetes care and their parents. In this phase, families will be randomly assigned to one of three study arms: parent motivation for monitoring and youth motivation for diabetes care (arm 1), parent motivation for monitoring and youth information (arm 2) or parent and youth information (arm 3). In phase 1 (development), youth and their caregivers will complete a one-time research visit where they use the program and provide feedback via a semi-structured interview regarding the usefulness of the content, its user-friendliness and make suggestions for changes to enhance acceptability. In phase 2 ( RCT), families will complete three intervention plus data collection visits and one additional data collection only visit. Research visits will be scheduled to coincide with appointments in the diabetes clinic to maximize convenience for families." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Diabetes" ] }, "KeywordList":{ "Keyword":[ "Parenting", "Parental Monitoring", "Diabetes", "Care" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Single", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"145", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Active Caregiver and Active Child", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Parent & Child Computer-Delivered Motivational Intervention will be delivered to participants. A brief computer delivered behavior change counseling intervention for parents of children with diabetes to improve monitoring of diabetes care and a brief computer delivered behavior change counseling intervention for children with diabetes to improve completion of daily diabetes care.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Parent & Child Computer-Delivered Motivational Intervention" ] } },{ "ArmGroupLabel":"Active Caregiver and Child Education", "ArmGroupType":"Experimental", "ArmGroupDescription":"Parent Computer-Delivered Motivational Intervention will be delivered to the parents only. A brief computer delivered behavior change counseling intervention for parents of children with diabetes to improve monitoring of diabetes care and a brief computer delivered informational session about diabetes related topics for their child with diabetes.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Parent Computer-Delivered Motivational Intervention" ] } },{ "ArmGroupLabel":"Education Caregiver/Education Child", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Participants will receive computer-delivered information. A brief computer delivered information session about diabetes related topics for both the caregiver and the child with diabetes.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Computer-Delivered Information" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Behavioral", "InterventionName":"Parent Computer-Delivered Motivational Intervention", "InterventionDescription":"Motivational Interviewing (MI) is a client-centered, directive method for enhancing intrinsic motivation to change by exploring & resolving ambivalence, with a strong evidence for improving adolescent & adult health behaviors. Three motivational sessions will be provided by an animated character who delivers the intervention with high fidelity to MI principles. Small amounts of psychoeducation about potential improvements illness management that can result from parental monitoring of diabetes care will be integrated with more purely motivational elements. Mailings will be sent to participants to remind them of the reasons they gave as motivation & goals they set regarding monitoring diabetes care.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Active Caregiver and Child Education" ] } },{ "InterventionType":"Behavioral", "InterventionName":"Parent & Child Computer-Delivered Motivational Intervention", "InterventionDescription":"Motivational Interviewing (MI) is a client-centered, directive method for enhancing intrinsic motivation to change by exploring & resolving ambivalence, with a strong evidence for improving adolescent & adult health behaviors. Three motivational sessions will be provided by an animated character who delivers the intervention with high fidelity to MI principles. Small amounts of psychoeducation about potential improvements illness management that can result from monitoring/completing diabetes care will be integrated with more purely motivational elements. Mailings will be sent to participants to remind them of the reasons they gave as motivation & goals they set regarding diabetes care.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Active Caregiver and Active Child" ] } },{ "InterventionType":"Behavioral", "InterventionName":"Computer-Delivered Information", "InterventionDescription":"Computer-Delivered Information about issues related to living with diabetes that do not directly impact completing diabetes care.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Education Caregiver/Education Child" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Diabetes Management Scale", "PrimaryOutcomeDescription":"The Diabetes Management Scale (DMS) (Frey, Ellis, Naar-King et al., 2004) is a self-report questionnaire used to measure a broad range of diabetes management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision.", "PrimaryOutcomeTimeFrame":"Each of 3 intervention session, 3-4 month apart" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Treatment Regulation Questionnaire", "SecondaryOutcomeDescription":"Parental motivation to monitor the youth is measured by the Treatment Self-Regulation Questionnaire (TSRQ; Ryan & Connell (1989). The TSRQ evaluates why people engage in a health-relevant behavior and assesses the degree to which one's motivation for a particular behavior or set of behaviors is relatively autonomous or self-determined as compared to derived from external pressures or constraints.", "SecondaryOutcomeTimeFrame":"Each of 3 intervention session, 3-4 month apart" },{ "SecondaryOutcomeMeasure":"Readiness Ruler", "SecondaryOutcomeDescription":"Parent motivation to monitor the youth is also measured by the Readiness Ruler (Stott, Rollnick, & Pill, 1995). Since readiness to change behaviors is behavior specific, the items will be tailored to assess the behaviors most critical to parental monitoring of diabetes management. The response format is a visual analog scale (VAS) 10 mm in length. Written cues anchor the ends and middle of the scale. Respondents mark their \"readiness\" on the scale and the position on the line is measured in millimeters.", "SecondaryOutcomeTimeFrame":"Each of 3 intervention session, 3-4 month apart" },{ "SecondaryOutcomeMeasure":"HbA1C Blood Test", "SecondaryOutcomeDescription":"Metabolic control will be measured via hemoglobin A1c (HbA1c). HbA1c is an indirect and retrospective measure of average blood glucose levels over the previous two to three month period.", "SecondaryOutcomeTimeFrame":"Each of 3 intervention session, 3-4 month apart" },{ "SecondaryOutcomeMeasure":"Parental Monitoring of Diabetes Care", "SecondaryOutcomeDescription":"The Parental Monitoring of Diabetes Care scale (PMDC) is an 18 item, investigator-developed questionnaire that measures the frequency of parental monitoring and direct supervision of diabetes care tasks such as insulin administration, blood glucose testing, and dietary management.", "SecondaryOutcomeTimeFrame":"Each of 3 intervention session, 3-4 month apart" },{ "SecondaryOutcomeMeasure":"Twenty-four Hour Recall Interview", "SecondaryOutcomeDescription":"The Twenty-four Hour Recall Interview, developed by Johnson and colleagues (Freund, Johnson, Silverstein et al., 1991), has been used extensively in pediatric diabetes research for the assessment of illness management.", "SecondaryOutcomeTimeFrame":"Each of 3 intervention session, 3-4 month apart" },{ "SecondaryOutcomeMeasure":"Blood Glucose Testing Frequency", "SecondaryOutcomeDescription":"Objective data on mean daily frequency of blood glucose testing during the 14-day period prior to data collection will be obtained directly from blood glucose meters.", "SecondaryOutcomeTimeFrame":"Each of 3 intervention session, 3-4 month apart" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAfrican American race/ethnicity\nAge: 10 years 0 months - 12 years, 11 months\nType 1 diabetes mellitus\nDiagnosed at least 6 months\nPatient of Children's Hospital of Michigan Diabetes Clinics\nEnglish fluency, both verbal and written\n\nExclusion Criteria:\n\nPsychiatry/psychological diagnoses including cognitive impairment that would prevent the participant from understanding the data collection measures, (i.e. moderate or severe mental retardation) or the following psychiatric diagnoses: autism and schizophrenia. Youth with current suicidal intent are not enrolled until psychiatrically stable.\nMedical diagnoses that would result in atypical diabetes management i.e. cystic fibrosis. Other medical conditions that would not affect diabetes management, such as asthma, do not exclude the participant from study participation.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"10 Years", "MaximumAge":"13 Years", "StdAgeList":{ "StdAge":[ "Child" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Deborah A Ellis, Ph.D.", "OverallOfficialAffiliation":"Wayne State University", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Wayne State University", "LocationCity":"Detroit", "LocationState":"Michigan", "LocationZip":"48201", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"25236503", "ReferenceType":"derived", "ReferenceCitation":"Idalski Carcone A, Ellis DA, Naar S, Ondersma SJ, Moltz K, Dekelbab B, Joseph CL. Enhancing parental motivation to monitor african american adolescents' diabetes care: development and Beta test of a brief computer-delivered intervention. JMIR Res Protoc. 2014 Sep 18;3(3):e43. doi: 10.2196/resprot.3220." } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"No" } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000003920", "ConditionMeshTerm":"Diabetes Mellitus" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000044882", "ConditionAncestorTerm":"Glucose Metabolism Disorders" },{ "ConditionAncestorId":"D000008659", "ConditionAncestorTerm":"Metabolic Diseases" },{ "ConditionAncestorId":"D000004700", "ConditionAncestorTerm":"Endocrine System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M5698", "ConditionBrowseLeafName":"Diabetes Mellitus", "ConditionBrowseLeafAsFound":"Diabetes", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10222", "ConditionBrowseLeafName":"Metabolic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M23990", "ConditionBrowseLeafName":"Glucose Metabolism Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6445", "ConditionBrowseLeafName":"Endocrine System Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "ConditionBrowseBranchAbbrev":"BC19", "ConditionBrowseBranchName":"Gland and Hormone Related Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }