Type 1 Diabetes Clinical Trial
— 3MsOfficial title:
Family mHealth Intervention to Improve Health Outcomes in Black Youth With Type 1 Diabetes
The purpose of this study is to conduct a multicenter, randomized effectiveness trial of The 3Ms 2.0 compared to an educational control condition for improving adolescent glycemic control and diabetes-related family relationships and reducing primary caregiver diabetes-related distress among Black adolescents with type 1 diabetes (T1D) and their primary caregivers. The proposed study would develop and test The 3Ms 2.0 adapted intervention when delivered using a mobile health approach (accessed via parents' cell phone). The intervention will also include new family intervention content (videoclips and text messages).
Status | Not yet recruiting |
Enrollment | 216 |
Est. completion date | March 2028 |
Est. primary completion date | March 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 14 Years |
Eligibility | Inclusion Criteria: - Age: 10 years, 0 months - 14 years, 11 months - Diagnosed with Type 1 diabetes - Diagnosed for at least 6 months - Black - Primary caregiver willing to participate - Residence within 30 miles of a recruitment site - Caregiver ownership of an Internet-enabled device (cell phone, laptop or desktop computer, tablet, etc) Exclusion Criteria: - Mental health conditions that might compromise data integrity (e.g., developmental delay, schizophrenia, psychosis, current suicidality, homicidality) - Co-morbid medical condition resulting in atypical diabetes management (e.g., cystic fibrosis) - Inability to speak or read English - Child is in out-of-home placement |
Country | Name | City | State |
---|---|---|---|
United States | LeBonheur Children's Hospital | Memphis | Tennessee |
United States | University of Tennessee Health Science Center-Memphis | Memphis | Tennessee |
United States | Children's National Hospital | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Wayne State University | National Institute on Minority Health and Health Disparities (NIMHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Illness Management | Diabetes Management Scale (DMS). The questionnaire's items are rated from 0 to 100. Higher scores reflect higher levels of diabetes care completion | Baseline, 3 months, 6 months, and 12 months | |
Other | Intervention Satisfaction | Exit interviews will be conducted to obtain caregiver perspectives regarding satisfaction with intervention content, delivery mode and dose using semi-structured interview guides. | 6 months | |
Primary | Glycemic Control | Hemoglobin A1c (HbA1c) | Baseline, 3 months, 6 months, and 12 months | |
Secondary | Caregiver Diabetes Distress | Parent Problem Areas in Diabetes (P-PAID). The questionnaire's items are rated on a scale from 1 (not a problem) to 6 (serious problem). Higher scores reflect more diabetes distress | Baseline, 3 months, 6 months, and 12 months | |
Secondary | Diabetes-Specific Family Conflict | Diabetes Family Conflict Scale-Short Form (DFCS-SF). The questionnaire's items are rated on a scale from 1 (almost never) to 3 (almost always). Higher scores reflect more family conflict | Baseline, 3 months, 6 months, and 12 months | |
Secondary | Diabetes-Specific Parental Monitoring | Parental Monitoring of Diabetes Care-Revised (PMDC-R). The questionnaire's items are rated from 1 to 5, with higher scores reflecting higher parental monitoring | Baseline, 3 months, 6 months and 12 months | |
Secondary | Diabetes-Specific Family Support | Diabetes Social Support Questionnaire-Family (DSSQ-Family). Items reflecting frequency of support are rated from 0 (never) to 5 (at least once a day). Items reflecting helpfulness of support are rated from 0(not at all) to 2 (very). Higher scores reflect more frequent family support and more helpful family support | Baseline, 3 months, 6 months and 12 months |
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