Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT04053504
Status:
COMPLETED
Last Update Posted:
2022-07-25
First Post:
2019-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility Study of Family Teamwork Peer-Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-22', 'studyFirstSubmitDate': '2019-07-08', 'studyFirstSubmitQcDate': '2019-08-08', 'lastUpdatePostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intervention Acceptability: Treatment Evaluation Inventory', 'timeFrame': 'Immediately post-intervention', 'description': 'Treatment Evaluation Inventory'}, {'measure': 'Study Enrollment Rate', 'timeFrame': 'Pre-Randomization', 'description': 'Enrollment rate calculated from data obtained from recruitment logs'}, {'measure': 'Study Attrition Rate', 'timeFrame': '12 months', 'description': 'Study attrition will be calculated from study logs'}, {'measure': 'Monthly Intervention Calls Completed by Parent Leaders', 'timeFrame': '12 months', 'description': 'Percentage of monthly intervention calls completed by Parent Leaders will be determined from study logs'}], 'secondaryOutcomes': [{'measure': 'Change in Rate of Average Blood Glucose', 'timeFrame': 'Change from baseline at 12 months', 'description': 'Hemoglobin A1C from medical record'}, {'measure': 'Change in Frequency of Adherence', 'timeFrame': 'Change from baseline at 12 months', 'description': 'Frequency of blood glucose monitoring obtained from blood glucose meter and the Diabetes Self-Management Questionnaire'}, {'measure': 'Change in Level of Child Diabetes Quality of Life: Pediatric Quality of Life Diabetes Module', 'timeFrame': 'Change from baseline at 12 months', 'description': 'Pediatric Quality of Life Total Cumulative Scale (scores range from 0-132 with higher scores indicating worse quality of life)'}, {'measure': 'Change in Level of Parent involvement in diabetes management tasks', 'timeFrame': 'Change from baseline at 12 months', 'description': 'The Diabetes Family Responsibility Questionnaire (scores range from 17-51 with lower scores indicating parent in primarily responsible for diabetes management)'}, {'measure': 'Change in Level of Parent self-efficacy', 'timeFrame': 'Change from baseline at 12 months', 'description': 'Parental Self-Efficacy for Diabetes Management questionnaire scores range from 8-40 with higher scores indicating higher self-efficacy)'}, {'measure': 'Change in Level of Parent diabetes emotional burden', 'timeFrame': 'Change from baseline at 12 months', 'description': 'Problem Areas in Diabetes Revised for Parents (scores range from 0-72 with higher scores indicating less emotional burden)'}, {'measure': 'Change in Level of Parent Depressive Symptoms', 'timeFrame': 'Change from baseline at 12 months', 'description': 'The Center for Epidemiological Depression Studies-Depression scale (scores range from 12-48 with higher scores indicating more depressive symptoms)'}, {'measure': 'Change in Level of Parent Social Support', 'timeFrame': 'Change from baseline at 12 months', 'description': '2-way Social Support Scale total score (scores range from 0-100 with higher scores indicating more giving and receiving of social support)'}, {'measure': 'Change in Degree of Impact of diabetes on the family system', 'timeFrame': 'Change from baseline at 12 months', 'description': 'Diabetes Family Impact Scale (scores range from 0-56 with higher scores indicating greater impact of diabetes on the family)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Health disparities', 'Family teamwork', 'Peer-delivered intervention', 'Facilitators to diabetes management', 'Barriers to diabetes management', 'Community-based intervention'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '40139919', 'type': 'DERIVED', 'citation': 'Butler AM, Hilliard ME, Christopher K, Baudino M, Minard C, Karaviti L. Feasibility and acceptability of the TEAM pilot trial with African American and Latino families. J Pediatr Psychol. 2025 May 1;50(5):388-398. doi: 10.1093/jpepsy/jsaf001.'}], 'seeAlsoLinks': [{'url': 'https://www.bcm.edu/departments/pediatrics/sections-divisions-centers/psychology/research/health-disparities-laboratory', 'label': 'PI lab page'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to 1) convene African American and Latino Community Coalitions to adapt Family Teamwork (FT) for school-age youth, and integrate FT with the Smart and Secure Children (SSC) program community-based, peer delivery format, 2) identify facilitators and barriers to parental involvement in diabetes management for African American and Latino parents of children (5-9 years) with T1D to refine, with Community Coalitions the adapted and integrated Family Teamwork- Peer Delivery (FT-P), and 3) evaluate the feasibility, satisfaction, and preliminary outcomes of the FT-P program among African American and Latino parents of school-aged children (5-9 years) withT1D.\n\nA randomized pilot trials will be conducted with African American and Latino families to examine the feasibility, parent satisfaction, and preliminary outcomes of FT-P. Families will be stratified by race/ethnicity, age, and HbA1c strata, and randomized to FT-P plus standard diabetes care or to standard diabetes care alone after completion of baseline assessment using a random numbers table generated by a program created through Baylor College of Medicine's Institute for Clinical Training and Research data management specialists."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary caregiver of a child ages 5-10 years with type 1 diabetes as defined by the American Diabetes Association criteria\n* Having a child with diabetes duration of \\>1 year\n* Self-identified African American or Latino race/ethnicity\n* Fluent in English\n* Not planning to leave the geographic area during the study\n\nExclusion Criterion:\n\n• Not fluent in English'}, 'identificationModule': {'nctId': 'NCT04053504', 'acronym': 'TEAM', 'briefTitle': 'Feasibility Study of Family Teamwork Peer-Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Feasibility Study of Family Teamwork Peer-Delivery', 'orgStudyIdInfo': {'id': 'H-40380'}, 'secondaryIdInfos': [{'id': 'DP3DK113236', 'link': 'https://reporter.nih.gov/quickSearch/DP3DK113236', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Behavioral intervention delivered by parent peer leaders.', 'interventionNames': ['Behavioral: Family Teamwork-Peer Delivery']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'Standard diabetes care'}], 'interventions': [{'name': 'Family Teamwork-Peer Delivery', 'type': 'BEHAVIORAL', 'description': 'Children with T1D and their parent will participate in 6 in-person FT-P group sessions during a 12-month period. Parents will also participate in monthly telephone support calls with a Parent Leader during the 12-month intervention period.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Ashley M Butler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Pediatrics-Psychology', 'investigatorFullName': 'Ashley Butler', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}