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存在差异，例如