Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT00480493
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
2007-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
STEP: Social Support To Empower Parents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'susan.sullivan-bolyai@umassmed.edu', 'phone': '508-856-4185', 'title': 'Susan Sullivan-Bolyai', 'organization': 'University of Massachusetts, Worcester'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We did not have enough parents recruited to look at structural equation modeling.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data tracked for entire study (3 years).', 'eventGroups': [{'id': 'EG000', 'title': 'Parent Mentor Contact', 'description': 'Parent mentor provides face-to-face, phone and/or e-mail social support', 'otherNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Arm', 'description': 'Parent in this group receives parent contact phone number that they can call for parent support', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maternal Confidence Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent Contact Control Arm', 'description': 'Parent contact control arm had a phone number only to call an experienced parent raising a child with type 1 diabetes to discuss support. The experienced parent contact did not initiate the contact.'}, {'id': 'OG001', 'title': 'Parent Mentor Experimental Arm', 'description': 'Parent mentor experimental arm had an assigned experienced parent raising a child with type 1 diabetes. The experienced parent mentor contacted the parent and negotiated the intervention dose, depending on need.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'spread': '7', 'groupId': 'OG000'}, {'value': '37', 'spread': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.468', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.46', 'ciLowerLimit': '-4.32', 'ciUpperLimit': '9.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.36', 'estimateComment': 'Confidence scores were also compared using random-effect, mixed regression models to determine whether changes over time differed significantly between groups.', 'groupDescription': 'A 2 sided t-test was used to determine if the change in Confidence score was significantly different between the groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Maternal confidence in managing child with type 1 diabetes . Higher total scores (10 questions, minimum score of 0, maximum score of 50) mean a better outcome (greater maternal confidence)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with data were analyzed'}, {'type': 'PRIMARY', 'title': 'Parent Concern', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent Contact Control Arm'}, {'id': 'OG001', 'title': 'Parent Mentor Experimental Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '149', 'spread': '38', 'groupId': 'OG000'}, {'value': '154', 'spread': '45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.634', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.82', 'ciLowerLimit': '-15.47', 'ciUpperLimit': '25.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.05', 'estimateComment': 'Concern scores were also compared using random-effect, mixed regression models to determine whether changes over time differed significantly between groups.', 'groupDescription': 'A 2 sided t-test was used to determine if there were significant differences in Concern between the two groups at 12 months.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': "Parent concern in managing child with type 1 diabetes. Higher total scores (58 questions, minimum score is 58; maximum score is 255) means more worry with managing child's diabetes care.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Worry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent Contact Control Arm'}, {'id': 'OG001', 'title': 'Parent Mentor Experimental Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'spread': '7', 'groupId': 'OG000'}, {'value': '27', 'spread': '7.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.430', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.48', 'ciLowerLimit': '-8.76', 'ciUpperLimit': '3.80', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.12', 'estimateComment': 'We also used a random-effect, mixed regression models to look for between group changes over time.', 'groupDescription': 'The difference in the Worry score at 12 months was compared between the groups using a 2 sided t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': "Parent worry in managing child's care. Higher total scores (11 questions, minimum score is 11, maximum score is 44) indicate more parental worry", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Parent Mentor Contact', 'description': 'Parent mentor provides face-to-face, phone and/or e-mail social support'}, {'id': 'FG001', 'title': 'Control Arm', 'description': 'Parent in this group receives parent contact phone number that they can call for parent support'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Mothers recruited from 2 pediatric diabetes clinics in NE US,randomized 1:1 to either E or C. Of 118 mothers approached, 30 declined due to hectic schedules or had enough support; 28 (24%) passive no. 60 mothers completed the consent and baseline data, randomized to either E (32) or C (28).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Parent Mentor Contact', 'description': 'Parent mentor provides face-to-face, phone and/or e-mail social support'}, {'id': 'BG001', 'title': 'Control Arm', 'description': 'Parent in this group receives parent contact phone number that they can call for parent support'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '36', 'spread': '6', 'groupId': 'BG001'}, {'value': '36', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Male', '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': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-21', 'studyFirstSubmitDate': '2007-05-29', 'resultsFirstSubmitDate': '2011-11-03', 'studyFirstSubmitQcDate': '2007-05-30', 'lastUpdatePostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-21', 'studyFirstPostDateStruct': {'date': '2007-05-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal Confidence Scale', 'timeFrame': '12 months', 'description': 'Maternal confidence in managing child with type 1 diabetes . Higher total scores (10 questions, minimum score of 0, maximum score of 50) mean a better outcome (greater maternal confidence)'}, {'measure': 'Parent Concern', 'timeFrame': '12 months', 'description': "Parent concern in managing child with type 1 diabetes. Higher total scores (58 questions, minimum score is 58; maximum score is 255) means more worry with managing child's diabetes care."}, {'measure': 'Worry', 'timeFrame': '12 months', 'description': "Parent worry in managing child's care. Higher total scores (11 questions, minimum score is 11, maximum score is 44) indicate more parental worry"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'This RCT intervention provides parental social support (informational, affirmational, and emotional) using parent mentors (experienced in the management of the chronic illness) for mothers and fathers of young children newly diagnosed with type 1 diabetes. The parent mentors provide both home visits and phone call support over the course of the first year after diagnosis. The hypothesis is that newly diagnosed parents who receive the intervention will perceive less parental concern and worry, less negative impact on the family, more perceived confidence and social support compared to those mothers and fathers not receiving the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mothers and fathers of children 12 years and younger with type 1 diabetes'}, 'identificationModule': {'nctId': 'NCT00480493', 'acronym': 'STEP', 'briefTitle': 'STEP: Social Support To Empower Parents', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'STEP: Social Support To Empower Parents', 'orgStudyIdInfo': {'id': '1R15NR008391-01', 'link': 'https://reporter.nih.gov/quickSearch/1R15NR008391-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parent mentor contact', 'description': 'Parent mentor provides face-to-face social support', 'interventionNames': ['Behavioral: STEP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Arm', 'description': 'Parent is given a phone contact', 'interventionNames': ['Behavioral: STEP']}], 'interventions': [{'name': 'STEP', 'type': 'BEHAVIORAL', 'otherNames': ['Experimental arm: receives parent mentor support', 'Control arm: receives phone number of parent contact'], 'description': 'Experimental: Minutes of parent mentor-parent participant interactions Control: Minutes of parent contact-parent participant interactions', 'armGroupLabels': ['Control Arm', 'Parent mentor contact']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts, Worcester', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'Susan Sullivan-Bolyai, DNSc CNS RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Worcester, Graduate School of Nurisng'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Principle Investigator', 'investigatorFullName': 'Susan Sullivan-Bolyai', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}