Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth

与青少年相关的糖尿病自我管理(DSM)和代谢控制的恶化 发育阶段是众所周知的。患有1型糖尿病(T1D)的非裔美国青少年 此类问题的风险更高。研究表明，育儿行为，如父母对孩子的监控 青少年完成日常糖尿病护理是青少年DSM的关键预测因素。低水平的父母 监测更有可能导致来自少数民族或低收入的患有T1D的青年的DSM较差 家。很少有针对青少年的研究表明，行为干预可以改善需求侧管理 也没有专门针对非裔美国青年的临床试验。此外， 目前还没有已发表的针对父母监控日常生活的干预措施的临床试验。 将糖尿病护理作为改善青少年需求侧管理的一种手段。由计算机提供的简短干预已经 在行为保健的许多领域显示出有希望的效果，也可能增加可获得性 向少数族裔家庭提供行为健康干预。我们小组最近进行了一项试点疗效试验，以 测试一次简短的、三次会议的计算机干预，旨在提高父母监督和 对年轻的非裔美国青少年的照顾者进行监测 独立自理。尽管干预措施是为糖尿病诊所定期提供而设计的 预约，为了我们的疗效试验，它是在诊所或在家中交付的 如果这家人错过了预定的诊所预约。功效研究的结果表明， 接受干预的照顾者对他们青少年的日常糖尿病的监测明显更高 管理层。接受干预的照顾者的青少年在 代谢控制与对照组比较。拟议研究的目的是进行一项多中心研究， 212例非裔美国青少年T1D及其相关人群干预的随机有效性试验 从美国各地的儿科内分泌诊所招募的初级照顾者。混合1设计 将使用，允许有关障碍/促进者的实施科学问题在 现实世界中的儿科糖尿病护理诊所有待解决。照顾者-青春期夫妇将随机 分配到两个研究小组中的一个：照顾者动机计算机干预，用于父母监测 糖尿病护理或护理者注意力控制。干预将在连续三个诊所进行 预约时间超过12个月，但只会在糖尿病诊所交付，以确定是否 在现实世界、有效条件下，干预可以改善需求侧管理和健康结局。剂量效应 还将对治疗结果的主持人进行评估。如果成功，这种干预有可能 改善健康结果，促进将行为健康干预措施纳入日常工作 在弱势青年群体中的医疗保健。

The deterioration in diabetes self-management (DSM) and metabolic control associated with the adolescent developmental period is well known. African American adolescents with Type 1 diabetes (T1D) are at even higher risk for such problems. Research has shown that parenting behaviors such as parental monitoring of adolescent completion of daily diabetes care are critical predictors of youth DSM. Low levels of parental monitoring are even more likely to result in poor DSM among youth with T1D from minority or low income homes. Few studies targeting adolescents have demonstrated that behavioral interventions can improve DSM or metabolic control, and no clinical trials have focused exclusively on African American youth. Furthermore, there have been no published clinical trials of interventions that have targeted parental monitoring of daily diabetes care as a means of improving DSM in adolescents. Computer-delivered, brief 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 minority families. Our group has recently conducted a pilot efficacy trial to test a brief, three session, computer intervention aimed at increasing parental motivation for supervision and monitoring among caregivers of young, African American adolescents who are beginning to transition to independent self-care. Although the intervention was designed for delivery in diabetes clinics at regularly scheduled appointments, for the purpose of our efficacy pilot, it was delivered either in the clinic or in the home if the family missed their scheduled clinic appointment. Results from the efficacy study suggested that caregivers who received the intervention had significantly higher monitoring of their adolescent’s daily diabetes management. Adolescents whose caregivers received the intervention had significant improvements in metabolic control compared to controls. The purpose of the proposed study is to conduct a multicenter, randomized effectiveness trial of the intervention with 212 African American adolescents with T1D and their primary caregivers recruited from pediatric endocrinology clinics across the United States. A Hybrid 1 design will be used, allowing implementation science questions about barriers/facilitators to intervention adoption in real world pediatric diabetes care clinics to be addressed. Caregiver-adolescent dyads will be randomly assigned to one of two study arms: caregiver motivational computer intervention for parental monitoring of diabetes care or caregiver attention control. The intervention will be delivered at three consecutive clinic appointments occurring over 12 months but will only be delivered in the diabetes clinic to determine if the intervention can improve DSM and health outcomes under real world, effectiveness conditions. Dose effects and moderators of treatment outcomes will also be evaluated. If successful, the intervention has the potential to improve health outcomes and to contribute to the integration of behavioral health interventions into routine medical care in a vulnerable population of youth.