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.

患有1型糖尿病（T1D）的黑人青少年在糖尿病相关的健康结果方面面临差异， 血糖控制欠佳的风险较高，可能导致糖尿病并发症。鉴于关键的 家庭在T1D青少年的健康中发挥的保护作用，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。然而，尽管广泛 文献记载的健康差异，一些随机临床试验，包括那些测试家庭为基础的， 干预措施包括足够的T1D黑人青少年样本。此外，严格，充分 测试专门为黑人青少年设计和定制的行为干预措施的有力临床试验 T1D患者和他们的家人都很缺乏。患有T1D的青少年的主要照顾者经历了高水平的 压力，抑郁和焦虑，黑人青年的照顾者更容易出现这种痛苦。基于家庭 对患有T1D的黑人青少年的干预措施不仅有可能改善个人的健康， 这不仅是青年的问题，而且也是照顾者的问题，因为改善家庭互动对照顾者也会产生溢出效应。 心理健康电子健康干预措施在许多行为健康领域显示出良好的效果 护理，也可能增加行为健康干预黑人家庭的可及性。我们集团 开发并测试了一种文化定制的简短电子健康干预设计，以促进最佳育儿 T1D黑人青少年的主要照顾者的做法。我们最近的临床试验的结果， 在糖尿病诊所就诊期间进行的干预显示出有希望的结果， 接受干预的护理人员改善了血糖控制，家庭报告糖尿病减少， 相关的家庭冲突。然而，调查结果也表明，需要进一步完善干预措施， 包括开发额外的内容，以帮助父母支持患有糖尿病的青少年， 管理拟议的研究将包括一个干预适应阶段，我们将召集 社区咨询委员会开发旨在优化糖尿病相关家庭互动的新材料 可以整合到现有的干预措施中。随后，我们将测试新的 干预措施，以改善青年血糖控制，改善糖尿病相关的家庭关系， 一项多中心随机对照试验中照顾者糖尿病相关的糖尿病困扰。新干预 将通过移动的保健方式提供，以优化其可及性。216例T1D黑人青少年， 他们的主要照顾者将从两个临床站点招募，并接受干预或关注 在六个月的窗口期内进行控制干预。此外，我们将评估干预的潜力， 缓冲社会和环境压力对青少年和照顾者健康的影响。剂量效应和 还将评估干预措施的成本效益。如果成功，干预措施有可能 改善青年及其家庭成员等弱势群体的健康状况。