Family mHealth Intervention to Improve Health Outcomes in Black Youth with Type 1 Diabetes: A Multi-Center Randomized Controlled Trial

家庭移动医疗干预可改善患有 1 型糖尿病的黑人青少年的健康结果：一项多中心随机对照试验

• 批准号: 10711185
• 负责人: DEBORAH A. ELLIS
• 金额: $ 69.85万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2027-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10711185
• 关键词: 15 year old; Adolescence; Adolescent; Affect; Anxiety; Area; Behavior; Behavior Therapy; Black race; Blood Glucose; Buffers; Caregivers; Caring; Child Rearing; Clinic; Clinic Visits; Clinical Trials; Collaborations; Communities; Complications of Diabetes Mellitus; Computer software; Conflict (Psychology); Cost Analysis; Development; Diabetes Mellitus; Disparity; Distress; Dose; Equity; Evaluation; Face; Family; Family Relationship; Family health status; Family member; Health; Health Technology; Healthcare; Hospitalization; Individual; Insulin-Dependent Diabetes Mellitus; Intervention; Intervention Trial; Interview; Literature; Mental Depression; Mental Health; Modeling; Motivation; Multi-Institutional Clinical Trial; Multicenter Trials; Neighborhoods; Outcome; Parents; Personal Satisfaction; Phase; Play; Racial Segregation; Randomized, Controlled Trials; Recording of previous events; Reporting; Research; Research Support; Risk; Risk Factors; Role; Sampling; Stress; Tablet Computer; Testing; Time; Vulnerable Populations; Work; Youth; adolescent health; attentional control; behavior change; behavior test; behavioral health; behavioral health intervention; clinical research site; cost effectiveness; design; diabetes distress; diabetes management; disparity reduction; eHealth; efficacy evaluation; efficacy testing; experience; follow-up; glycemic control; health disparity; high risk; improved; independent self care; intervention cost; intervention refinement; mHealth; parental monitoring; poor health outcome; primary care practice; primary caregiver; primary endpoint; protective factors; racism; randomized, clinical trials; recruit; resilience; secondary endpoint; social; stressor; therapy design

Black adolescents with type 1 diabetes (T1D) face disparities in diabetes-related health outcomes such as higher risk for suboptimal glycemic control, which can lead to diabetes complications. Given the critical protective role played by families in the health of adolescents with T1D, family-based interventions have commonly been used as a strategy to promote optimal adolescent health. However, despite the extensive literature documenting health disparities, few randomized clinical trials, including those testing family-based- interventions, have included adequate samples of Black adolescents with T1D. Moreover, rigorous, adequate powered clinical trials testing behavioral interventions specifically designed and tailored for Black adolescents with T1D and their families are lacking. Primary caregivers of youth with T1D experience elevated levels of stress, depression and anxiety, and caregivers of Black youth are at higher risk for such distress. Family-based interventions for Black adolescents with T1D hold the potential to improve the health not only of the individual youth but of the caregiver as well, as improved family interactions can have spillover effects for caregiver mental health. eHealth interventions have shown promising effects in a number of areas of behavioral health care and may also increase the accessibility of behavioral health interventions to Black families. Our group has developed and tested a culturally tailored, brief eHealth intervention design to promote optimal parenting practices for primary caregivers of Black adolescents with T1D. Results of our recent clinical trial where the intervention was delivered during diabetes clinic visits showed promising results, as adolescents whose caregivers received the intervention had improved glycemic control and families reported reduced diabetes- related family conflict. However, findings also suggested the need for further refinement of the intervention, including the development of additional content to help parents support their adolescent with diabetes management. The proposed study will include an intervention adaptation phase where we will convene community advisory boards to develop new material designed to optimize diabetes-related family interactions that can be integrated into the existing intervention. Subsequently, we will test the efficacy of the new intervention to improve youth glycemic control, improve diabetes-related family relationships and reduce caregiver diabetes-related diabetes distress in a multi-center, randomized controlled trial. The new intervention will be delivered via a mobile health approach to optimize its accessibility. 216 Black adolescents with T1D and their primary caregiver will be recruited from two clinical sites and receive the intervention or an attention control intervention during a six-month window. Additionally, we will evaluate the intervention’s potential to buffer the impact of social and contextual stressors on adolescent and caregiver health. Dose effects and intervention cost-effectiveness will also be evaluated. If successful, the intervention has the potential to improve health outcomes in a vulnerable population of youth and their family members.

具有1型糖尿病（T1D）的黑人青少年在与糖尿病相关的健康结果中的面部分布（例如 次优血糖控制的风险更高，这可能导致糖尿病并发症。给定批判 家庭在具有T1D的青少年的健康中扮演的保护作用，基于家庭的干预措施 通常被用作促进最佳青少年健康的策略。但是，做大量 记录健康分布的文献，很少有随机临床试验，包括测试基于家庭的测试 干预措施包括具有T1D的黑人青少年的足够样本。而且，严格，足够 专门针对黑人青少年设计和量身定制的有能力的临床试验测试行为干预措施 由于T1D及其家人缺乏。 T1D青年的初级护理人员的经验较高 压力，抑郁和焦虑以及黑人青年的看护人遭受这种困扰的风险更高。基于家庭 黑人青少年的干预措施不仅有可能改善个人的健康 青年，但也是照顾者的年轻人，因为改善的家庭互动可能会对照料者产生敏感效果 心理健康。 eHealth干预措施在许多行为健康领域显示出希望的影响 护理，还可能增加对黑人家庭的行为健康干预措施的可及性。我们的小组有 开发并测试了一种文化量身定制的简短eHealth干预设计，以促进最佳育儿 T1D的黑人青少年初级护理人员的实践。我们最近的临床试验的结果 在糖尿病诊所就诊期间提供干预措施，显示了有希望的结果，作为青少年的 护理人员接受干预措施改善了血糖控制，家庭报告糖尿病减少 - 相关的家庭冲突。但是，调查结果还表明需要进一步完善干预措施， 包括开发其他内容，以帮助父母支持糖尿病的青少年 管理。拟议的研究将包括一个干预适应阶段，我们将在其中召集 社区咨询委员会开发旨在优化与糖尿病相关的家庭互动的新材料 可以将其集成到现有的干预措施中。随后，我们将测试新的效率 干预以改善青年血糖控制，改善与糖尿病相关的家庭关系并减少 在多中心，随机对照试验中，护理人员糖尿病相关的糖尿病困扰。新干预 将通过移动健康方法交付以优化其可访问性。 216个带有T1D的黑人青少年 他们的主要护理人员将从两个临床部位招募，并受到干预或关注 在六个月的窗口中控制干预措施。此外，我们将评估干预的潜力 缓冲社会和情境压力源对青少年和照料者健康的影响。剂量影响和 干预成本效益也将进行评估。如果成功，干预有可能 改善弱势青年及其家人的健康状况。