Feasibility Study of Family Teamwork Peer-Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Intervention Acceptability: Treatment Evaluation Inventory
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary caregiver of a child ages 5-10 years with type 1 diabetes as defined by the American Diabetes Association criteria
- •Having a child with diabetes duration of >1 year
- •Self-identified African American or Latino race/ethnicity
- •Fluent in English
- •Not planning to leave the geographic area during the study
- •Exclusion Criterion:
- •Not fluent in English
排除标准
- 未提供
结局指标
主要结局
Intervention Acceptability: Treatment Evaluation Inventory
时间窗: Immediately post-intervention
Treatment Evaluation Inventory
Study Attrition Rate
时间窗: 12 months
Study attrition will be calculated from study logs
Study Enrollment Rate
时间窗: Pre-Randomization
Enrollment rate calculated from data obtained from recruitment logs
Monthly Intervention Calls Completed by Parent Leaders
时间窗: 12 months
Percentage of monthly intervention calls completed by Parent Leaders will be determined from study logs
次要结局
- Change in Level of Parent diabetes emotional burden(Change from baseline at 12 months)
- Change in Level of Parent Depressive Symptoms(Change from baseline at 12 months)
- Change in Rate of Average Blood Glucose(Change from baseline at 12 months)
- Change in Level of Parent self-efficacy(Change from baseline at 12 months)
- Change in Frequency of Adherence(Change from baseline at 12 months)
- Change in Level of Child Diabetes Quality of Life: Pediatric Quality of Life Diabetes Module(Change from baseline at 12 months)
- Change in Level of Parent involvement in diabetes management tasks(Change from baseline at 12 months)
- Change in Level of Parent Social Support(Change from baseline at 12 months)
- Change in Degree of Impact of diabetes on the family system(Change from baseline at 12 months)
研究者
Ashley Butler
Associate Professor, Pediatrics-Psychology
Baylor College of Medicine