Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-02-22 @ 9:04 AM
Study NCT ID:
NCT03168867
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2017-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)
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': 'dellis@med.wayne.edu', 'phone': '313-577-1055', 'title': 'Deborah Ellis, Ph.D.', 'organization': 'Wayne State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year, 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Educational Care Control', 'description': 'Participants in the standard educational control group received education regarding type 1 diabetes management during their routine clinic visits. Education was consistent with the standard care provided by each of the study sites.', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 29, 'seriousNumAtRisk': 74, 'deathsNumAffected': 0, 'seriousNumAffected': 29}, {'id': 'EG001', 'title': 'The 3Ms Intervention + Standard Educational Care', 'description': "The 3Ms was a brief e-health intervention delivered via an internet-based software application (CIAS) that incorporated principles of Motivational Interviewing. The goal of The 3Ms was to provide psychoeducation regarding the value of daily parental supervision of adolescent diabetes management and increase the primary caregiver's motivation to supervise adolescents' daily diabetes management. The intervention consisted of three brief 10-15 minute sessions delivered on a tablet computer during routine diabetes clinic appointments.", 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 21, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Domestic violence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New Diabetes-Related Health Problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New Non-diabetes-Related Health Problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Problem with Parent-Child Relations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric Problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'School Related Problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening Diabetes-Related Health Problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New Family Problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 22, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 17, 'numAffected': 11}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New Non-diabetes-Related Health Problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood glucose less than 50 mg/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening Diabetes-Related Health Problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New Psychiatric Problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Glycemic Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Educational Care Control', 'description': 'Participants in the standard educational control group received education regarding type 1 diabetes management during their routine clinic visits. Education was consistent with the standard care provided by each of the study sites.'}, {'id': 'OG001', 'title': 'The 3Ms Intervention + Standard Educational Care', 'description': "The 3Ms was a brief e-health intervention delivered via an internet-based software application (CIAS) that incorporated principles of Motivational Interviewing. The goal of The 3Ms was to provide psychoeducation regarding the value of daily parental supervision of adolescent diabetes management and increase the primary caregiver's motivation to supervise adolescents' daily diabetes management. The intervention consisted of three brief 10-15 minute sessions delivered on a tablet computer during routine diabetes clinic appointments."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.51', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '11.48', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': '6 month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.55', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '11.14', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': '13 month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.47', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '11.09', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': '18 month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.47', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '10.76', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6, 13 and 18 month follow-up', 'description': 'Hemoglobin A1c (HbA1c)', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were intent-to-treat. All randomized participants were included in the analyses'}, {'type': 'SECONDARY', 'title': 'Regimen Adherence (Objective)', 'timeFrame': 'Baseline, 6 months, 13 months, and 18 months', 'description': 'Glucose Meter (frequency of testing)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Diabetes Management (Self-reported)', 'timeFrame': 'Baseline, 6 months, 13 months, and 18 months', 'description': 'Diabetes Management Scale (DMS)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Parental Monitoring of Diabetes Care (Self-reported)', 'timeFrame': 'Baseline, 6 months, 13 months, and 18 months', 'description': 'The Parental Monitoring of Diabetes Care-Revised (PMDC-R)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Diabetes- Specific Family Functioning (Self-reported)', 'timeFrame': 'Baseline, 6 months, 13 months, and 18 months', 'description': 'Diabetes Family Conflict Scale (DFCS-R)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Adolescent Depression (Self-reported)', 'timeFrame': 'Baseline, 6 months, 13 months, and 18 months', 'description': 'Patient Reported Outcomes Measurement Information System (PROMIS)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Executive Functioning (Self-reported)', 'timeFrame': 'Baseline, 6 months, 13 months, and 18 months', 'description': 'Behavior Rating Inventory of Executive Function (BRIEF)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Cost Analysis (Self-reported)', 'timeFrame': 'Baseline, 6 months, 13 months, and 18 months', 'description': 'EuroQol five-dimensional (EQ-5D)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Diabetes Emotional Distress (Self-reported)', 'timeFrame': 'Baseline, 6 months, 13 months, and 18 months', 'description': 'Problem Areas in Diabetes (PAID)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Household Chaos (Self-reported)', 'timeFrame': 'Baseline, 6 months, 13 months, and 18 months', 'description': 'Confusion, Hubbub, and Order Scale (CHAOS)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Educational Care Control', 'description': 'Participants in the standard educational control group received education regarding type 1 diabetes management during their routine clinic visits. Education was consistent with the standard care provided by each of the study sites.'}, {'id': 'FG001', 'title': 'The 3Ms Intervention + Standard Educational Care', 'description': "The 3Ms was a brief e-health intervention delivered via an internet-based software application (CIAS) that incorporated principles of Motivational Interviewing. The goal of The 3Ms was to provide psychoeducation regarding the value of daily parental supervision of adolescent diabetes management and increase the primary caregiver's motivation to supervise adolescents' daily diabetes management. The intervention consisted of three brief 10-15 minute sessions delivered on a tablet computer during routine diabetes clinic appointments."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Educational Care Control', 'description': 'Participants in the standard educational control group received education regarding type 1 diabetes management during their routine clinic visits. Education was consistent with the standard care provided by each of the study sites.'}, {'id': 'BG001', 'title': 'The 3Ms Intervention + Standard Educational Care', 'description': "The 3Ms was a brief e-health intervention delivered via an internet-based software application (CIAS) that incorporated principles of Motivational Interviewing. The goal of The 3Ms was to provide psychoeducation regarding the value of daily parental supervision of adolescent diabetes management and increase the primary caregiver's motivation to supervise adolescents' daily diabetes management. The intervention consisted of three brief 10-15 minute sessions delivered on a tablet computer during routine diabetes clinic appointments."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '13.1', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '13.4', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hemoglobin A1c', 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '11.5', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '11.5', 'spread': '2.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-20', 'size': 146520, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-17T10:33', 'hasProtocol': True}, {'date': '2017-07-24', 'size': 388667, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-09-12T11:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-17', 'studyFirstSubmitDate': '2017-05-24', 'resultsFirstSubmitDate': '2023-02-09', 'studyFirstSubmitQcDate': '2017-05-25', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-17', 'studyFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic Control', 'timeFrame': 'Baseline, 6, 13 and 18 month follow-up', 'description': 'Hemoglobin A1c (HbA1c)'}], 'secondaryOutcomes': [{'measure': 'Regimen Adherence (Objective)', 'timeFrame': 'Baseline, 6 months, 13 months, and 18 months', 'description': 'Glucose Meter (frequency of testing)'}, {'measure': 'Diabetes Management (Self-reported)', 'timeFrame': 'Baseline, 6 months, 13 months, and 18 months', 'description': 'Diabetes Management Scale (DMS)'}, {'measure': 'Parental Monitoring of Diabetes Care (Self-reported)', 'timeFrame': 'Baseline, 6 months, 13 months, and 18 months', 'description': 'The Parental Monitoring of Diabetes Care-Revised (PMDC-R)'}, {'measure': 'Diabetes- Specific Family Functioning (Self-reported)', 'timeFrame': 'Baseline, 6 months, 13 months, and 18 months', 'description': 'Diabetes Family Conflict Scale (DFCS-R)'}, {'measure': 'Adolescent Depression (Self-reported)', 'timeFrame': 'Baseline, 6 months, 13 months, and 18 months', 'description': 'Patient Reported Outcomes Measurement Information System (PROMIS)'}, {'measure': 'Executive Functioning (Self-reported)', 'timeFrame': 'Baseline, 6 months, 13 months, and 18 months', 'description': 'Behavior Rating Inventory of Executive Function (BRIEF)'}, {'measure': 'Cost Analysis (Self-reported)', 'timeFrame': 'Baseline, 6 months, 13 months, and 18 months', 'description': 'EuroQol five-dimensional (EQ-5D)'}, {'measure': 'Diabetes Emotional Distress (Self-reported)', 'timeFrame': 'Baseline, 6 months, 13 months, and 18 months', 'description': 'Problem Areas in Diabetes (PAID)'}, {'measure': 'Household Chaos (Self-reported)', 'timeFrame': 'Baseline, 6 months, 13 months, and 18 months', 'description': 'Confusion, Hubbub, and Order Scale (CHAOS)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['insulin dependent diabetes mellitus', 'adolescents/young adults', 'e-health intervention', 'parental monitoring'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '40859913', 'type': 'DERIVED', 'citation': 'Knauft KM, Jacques-Tiura AJ, Carcone AI, Evans MA, Weissberg-Benchell J, Buggs-Saxton C, Boucher-Berry C, Miller JL, Drossos T, Dekelbab MB, Ellis D. Blood Glucose Levels and Diabetes Family Conflict in Black Adolescents with Type 1 Diabetes During the COVID-19 Pandemic. Behav Med. 2025 Aug 27:1-15. doi: 10.1080/08964289.2025.2543265. Online ahead of print.'}, {'pmid': '38775162', 'type': 'DERIVED', 'citation': 'Knauft KM, Jacques-Tiura AJ, Idalski Carcone A, Evans M, Weissberg-Benchell J, Buggs-Saxton C, Boucher-Berry C, Miller JL, Drossos T, Dekelbab B, Ellis DA. The moderating role of diabetes distress on the effect of a randomized eHealth intervention on glycemic control in Black adolescents with type 1 diabetes. J Pediatr Psychol. 2024 Aug 1;49(8):538-546. doi: 10.1093/jpepsy/jsae033.'}, {'pmid': '38593428', 'type': 'DERIVED', 'citation': 'Ellis D, Carcone AI, Templin T, Evans M, Weissberg-Benchell J, Buggs-Saxton C, Boucher-Berry C, Miller JL, Drossos T, Dekelbab MB. Moderating Effect of Depression on Glycemic Control in an eHealth Intervention Among Black Youth With Type 1 Diabetes: Findings From a Multicenter Randomized Controlled Trial. JMIR Diabetes. 2024 Apr 9;9:e55165. doi: 10.2196/55165.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to conduct a multicenter, randomized effectiveness trial of The 3Ms. The proposed study will use an effectiveness-implementation "Hybrid 1" design. In this design, the primary goal is to determine whether an intervention works in a real-world setting, but the design also answers secondary questions such as the relationship between treatment dose and treatment outcome and what factors affect the actual delivery of the intervention in the clinics (staff burden, workflow interference etc).', 'detailedDescription': "The study will be conducted at 3 clinics in the Detroit area (Children's Hospital of Michigan (CHM); Ascension St. John Children's Hospital; William Beaumont Children's Hospital) and 4 clinics in the Chicago area. Wayne State University (WSU) will function as the coordinating center for the trial and will be responsible for overseeing the adequacy all aspects of trial management, including recruitment, retention, data collection, data management and statistical analyses. 212 African American (AA) adolescents with type 1 diabetes and their primary caregivers will be enrolled across all sites (half will be enrolled at WSU and half at the 4 Chicago sites). Families will be randomized to one of two arms: The 3Ms intervention (parental motivation for supervision of adolescent DSM) or standard educational control. In the 3Ms condition, parents will receive a brief (10-20 minute) computer delivered intervention at three consecutive routine diabetes clinic visits that is designed to increase parental motivation to supervise adolescent diabetes management. In the control condition, parents will receive computer-delivered education materials regarding type 1 diabetes. Data collection will be completed in the diabetes clinic at baseline and then at 6, 12 and 18 months after baseline in the families' home. Data collection is completed by the adolescent and caregiver on a tablet computer and includes questionnaires to assess adolescent diabetes management, parental supervision of diabetes management, family relationships and youth quality of life. Blood will also be collected to measure HbA1c (mean blood glucose level). Medical record data will also be collected. The data analyses will be intent-to-treat, meaning that all randomized participants are included regardless of the intervention dose received. Trial data will analyzed using the linear mixed effect model (LME) for repeated measures.\n\nIn addition to the clinical trial, 20 diabetes clinic staff members (5 at WSU from the CHM clinic; 15 from the Chicago clinics) will also be recruited to participate in qualitative interviews upon completion of the trial. The purpose of the interview is to identify barriers and facilitators of use of the 3Ms intervention at the level of the individual clinician, the diabetes clinic and the organization (hospital). Interviews will be audiotaped and subsequently transcribed for coding."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: 10 years 0 months - 15 years, 11 months\n* Diagnosed with Type 1 diabetes\n* Diagnosed for at least 6 months\n* African American\n* Residence within 30 miles of a recruitment site (Children's Hospital of Michigan, Ann and Robert H. Lurie Children's Hospital of Chicago, Children's Hospital University of Illinois, or La Rabida Children's Hospital of Chicago)\n* Primary caregiver willing to participate\n\nExclusion Criteria:\n\n* Mental health conditions that might compromise data integrity (e.g., developmental delay, schizophrenia, psychosis, current suicidality, homicidality)\n* Co-morbid medical condition resulting in atypical diabetes management (e.g., cystic fibrosis)\n* Inability to speak or read English\n* Child is in out-of-home placement"}, 'identificationModule': {'nctId': 'NCT03168867', 'acronym': '3Ms', 'briefTitle': 'Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)', 'organization': {'class': 'OTHER', 'fullName': 'Wayne State University'}, 'officialTitle': 'Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)', 'orgStudyIdInfo': {'id': '015117B3E'}, 'secondaryIdInfos': [{'id': 'R01DK110075', 'link': 'https://reporter.nih.gov/quickSearch/R01DK110075', 'type': 'NIH'}, {'id': '1R01DK110075-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DK110075-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Educational Control', 'description': 'Participants in the standard educational control group will be provided with standard care regarding type 1 diabetes management during their routine clinic visits as usual. The standard care will be consistent with diabetes education provided by each of the study sites.'}, {'type': 'EXPERIMENTAL', 'label': 'The 3Ms Intervention + Standard Care', 'description': 'Parents will complete the first intervention session in the diabetes clinic immediately after baseline data collection and randomization. The subsequent two intervention sessions will also be conducted during regularly scheduled diabetes clinic visits.', 'interventionNames': ['Behavioral: The 3Ms Intervention']}], 'interventions': [{'name': 'The 3Ms Intervention', 'type': 'BEHAVIORAL', 'description': "The 3 Ms is a brief e-health intervention delivered via an internet-based software application (CIAS) that incorporates principles of Motivational Interviewing. The goal of the 3 Ms intervention is to increase caregiver motivation to supervise children's daily diabetes care. The intervention consists of 3 brief sessions that are delivered at routine diabetes clinic appointments.", 'armGroupLabels': ['The 3Ms Intervention + Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Children's Hospital University of Illinois", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "UChicago Medicine Comer Children's Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60649', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "La Rabida Children's Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Children's Hospital of Michigan", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48236', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Ascension St. John Children's Hospital", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': "William Beaumont Children's Hospital", 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}], 'overallOfficials': [{'name': 'Deborah A Ellis, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wayne State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wayne State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Family Medicine and Public Health Sciences Wayne State University School of Medicine', 'investigatorFullName': 'Deborah Ellis, Ph.D.', 'investigatorAffiliation': 'Wayne State University'}}}}