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| ID | Type | Description | Link |
|---|---|---|---|
| DP3DK113236 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
A 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Behavioral intervention delivered by parent peer leaders. |
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| Standard Care | No Intervention | Standard diabetes care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family Teamwork-Peer Delivery | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Acceptability: Treatment Evaluation Inventory | Treatment Evaluation Inventory | Immediately post-intervention |
| Study Enrollment Rate | Enrollment rate calculated from data obtained from recruitment logs | Pre-Randomization |
| Study Attrition Rate | Study attrition will be calculated from study logs | 12 months |
| Monthly Intervention Calls Completed by Parent Leaders | Percentage of monthly intervention calls completed by Parent Leaders will be determined from study logs | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Rate of Average Blood Glucose | Hemoglobin A1C from medical record | Change from baseline at 12 months |
| Change in Frequency of Adherence | Frequency of blood glucose monitoring obtained from blood glucose meter and the Diabetes Self-Management Questionnaire |
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Inclusion Criteria:
Exclusion Criterion:
• Not fluent in English
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| Name | Affiliation | Role |
|---|---|---|
| Ashley M Butler, PhD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40139919 | Derived | 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. |
| Label | URL |
|---|---|
| PI lab page | View source |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Change from baseline at 12 months |
| Change in Level of Child Diabetes Quality of Life: Pediatric Quality of Life Diabetes Module | Pediatric Quality of Life Total Cumulative Scale (scores range from 0-132 with higher scores indicating worse quality of life) | Change from baseline at 12 months |
| Change in Level of Parent involvement in diabetes management tasks | The Diabetes Family Responsibility Questionnaire (scores range from 17-51 with lower scores indicating parent in primarily responsible for diabetes management) | Change from baseline at 12 months |
| Change in Level of Parent self-efficacy | Parental Self-Efficacy for Diabetes Management questionnaire scores range from 8-40 with higher scores indicating higher self-efficacy) | Change from baseline at 12 months |
| Change in Level of Parent diabetes emotional burden | Problem Areas in Diabetes Revised for Parents (scores range from 0-72 with higher scores indicating less emotional burden) | Change from baseline at 12 months |
| Change in Level of Parent Depressive Symptoms | The Center for Epidemiological Depression Studies-Depression scale (scores range from 12-48 with higher scores indicating more depressive symptoms) | Change from baseline at 12 months |
| Change in Level of Parent Social Support | 2-way Social Support Scale total score (scores range from 0-100 with higher scores indicating more giving and receiving of social support) | Change from baseline at 12 months |
| Change in Degree of Impact of diabetes on the family system | Diabetes Family Impact Scale (scores range from 0-56 with higher scores indicating greater impact of diabetes on the family) | Change from baseline at 12 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |