Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-24 @ 12:11 PM
Study NCT ID:
NCT03255902
Status:
COMPLETED
Last Update Posted:
2019-07-26
First Post:
2017-08-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Family Routines - Healthy Families
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'donna.marvicsin@beaumont.org', 'phone': '248-568-6932', 'title': 'Donna Marvicsin, Nurse Practitioner, Pediatric Endocrinology', 'organization': 'William Beaumont Hospitals'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'description': 'A questionnaire and survey was used to collect information for this study. Participants were carefully observed for any signs of anxiety or discomfort or any serious adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Families Attending Parenting Class', 'description': 'Families attended 6 parenting sessions, filled out daily glucose screens, \\& questionnaires.\n\nParenting Classes: The Incredible Years curriculum', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effect of Intervention on Evening Glucose Control.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Families Attending Parenting Classes', 'description': 'Families attended 6 parenting sessions, filled out daily glucose screens, \\& questionnaires\n\nParenting classes: Parenting Classes:The Incredible Years curriculum'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After 6 weeks of classes', 'description': 'Number of families whose child achieved a decrease overnight between bedtime blood glucose level and morning fasting glucose level following intervention at 6 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 participants did not complete study'}, {'type': 'SECONDARY', 'title': "Difference Between Child's Pre-intervention and 3 Month Hemoglobin A1c Value", 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Families Attending Parenting Classes', 'description': 'Families attended 6 parenting sessions, filled out daily glucose screens, \\& questionnaires\n\nParenting classes: Parenting Classes:The Incredible Years curriculum'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '0.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre intervention to 3 months post intervention', 'description': '3-month Hemoglobin A1c value subtracted from pre-intervention Hemoglobin A1c value. Positive numbers indicate an improvement in glucose control with intervention, and negative numbers indicate no improvement in glucose control with intervention.', 'unitOfMeasure': 'percent of HbA1c', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '2 participants did not complete study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Families Attending Parenting Classes', 'description': 'Families attended 6 parenting sessions, filled out daily glucose screens, \\& questionnaires\n\nParenting classes: Parenting Classes:The Incredible Years curriculum'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Families Attending Parenting Classes', 'description': 'Families attended 6 parenting sessions, filled out daily glucose screens, \\& questionnaires\n\nParenting classes: Parenting Classes:The Incredible Years curriculum'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '7 parents enrolled with children between the ages of 2 to 5 years old, but 2 did not complete.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-29', 'size': 3000281, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-01-30T15:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This feasibility study will be a mixed methods non-randomized trial to examine the feasibility of combining a parent skill training intervention with a family evening routine intervention. Evidence of feasibility will include attendance, activities completed, and interviews.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-29', 'studyFirstSubmitDate': '2017-08-16', 'resultsFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2017-08-18', 'lastUpdatePostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-29', 'studyFirstPostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Intervention on Evening Glucose Control.', 'timeFrame': 'After 6 weeks of classes', 'description': 'Number of families whose child achieved a decrease overnight between bedtime blood glucose level and morning fasting glucose level following intervention at 6 weeks.'}], 'secondaryOutcomes': [{'measure': "Difference Between Child's Pre-intervention and 3 Month Hemoglobin A1c Value", 'timeFrame': 'Pre intervention to 3 months post intervention', 'description': '3-month Hemoglobin A1c value subtracted from pre-intervention Hemoglobin A1c value. Positive numbers indicate an improvement in glucose control with intervention, and negative numbers indicate no improvement in glucose control with intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'The purpose of the proposed study, Family Routines - Healthy Families, is to examine the feasibility and acceptability of a parenting/family routine intervention program for parents of young children, ages 2-5, with type 1 diabetes.', 'detailedDescription': 'The intervention in Family Routines - Healthy Families contains an established and effective parent skills training curriculum called "The Incredible Years," uniquely integrated with a newly developed family evening routine component e.g., family dinner time and evening routine, to promote improved metabolic control. The investigator will assess outcomes during and at one week post intervention. Outcome measures will include family routine, specifically the time between the dinner and bedtime glucose check, parent bedtime decision making, and child overnight glucose control. In addition, parental quality of life and receptiveness to the intervention will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Self identification as primary care giver of child that fits following criteria:\n\n 1. Age 2 - 5 years\n 2. Diagnosis of Type 1 diabetes\n 3. Most recent Hemoglobin A1c (HbA1c) \\> 8.0\n 4. Child a patient of Pediatric Endocrinology, Beaumont Children's Hospital\n2. English fluency\n\nExclusion Criteria:\n\n1. Cognitively impaired\n2. Does not meet inclusion criteria"}, 'identificationModule': {'nctId': 'NCT03255902', 'briefTitle': 'Family Routines - Healthy Families', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health East'}, 'officialTitle': 'Family Routine - Healthy Families', 'orgStudyIdInfo': {'id': '2016-154'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Families attending parenting classes', 'description': 'Families attended 6 parenting sessions, filled out daily glucose screens, \\& questionnaires', 'interventionNames': ['Behavioral: Parenting classes']}], 'interventions': [{'name': 'Parenting classes', 'type': 'BEHAVIORAL', 'description': 'Parenting Classes:The Incredible Years curriculum', 'armGroupLabels': ['Families attending parenting classes']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Donna Marvicsin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "William Beaumont Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corewell Health East', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Michigan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nurse Practitioner, Pediatric Endocrinology', 'investigatorFullName': 'Donna Marvicsin', 'investigatorAffiliation': 'Corewell Health East'}}}}