iKinnect Mobile Technology to Reduce Teen Substance Misuse and Health Disparities

项目摘要/摘要 青少年药物滥用(SA)被称为美国头号公共卫生问题，影响着 作为所有18岁以下青年的16%，并经常导致严重的后果，如参与犯罪， 健康问题和自杀。鉴于青少年SA与高发病率的共病有关 精神健康(MH)问题和自杀风险增加，综合SA-MH治疗涉及认知- 以行为和家庭治疗为基础的方法以及早期干预至关重要。然而，很少有青少年 接受任何SA治疗，未得到满足的服务需求可能会在以下新冠肺炎相关事件后增加 压力因素，这对黑人、土著和其他有色人种青年造成了不成比例的影响。在文化上发展- 适当的移动应用程序技术可有效解决青少年SA、MH症状和自杀风险， 在新的通用环境中交付，并使用直接面向消费者和家庭同行支持专家 这些技术可能会对公共卫生产生大规模和极具成本效益的影响。 IKinnect是一个配对的移动应用平台，支持父母(在交付中)和年轻人(在接收中) 减少青少年问题行为的循证做法。基于多系统治疗原则， IKinNett1.0最初是为了帮助有严重品行问题的青少年而设计的。来自随机调查的结果 对照试验(RCT；N=72)证实了其在减少外化行为和改善方面的有效性 严重品行障碍青少年的父母教养效果。IKinnect目前正在进行改编，以适应更多 青少年司法系统中有自杀倾向的青少年及其父母严重混乱。我们现在寻求 要显著调整iKinnect以供有问题的青少年使用，并 他们的父母减少SA及其有害影响，阿片类药物过量，以及进展为物质使用障碍， 以及其他因SA而加剧和/或干扰SA治疗的行为健康问题。 这一为期34个月的快速通道旨在显著解决青少年中SA和共同发生的MH问题 采用iKinnect向从事以下工作的一般人群青年提供循证SA和MH干预 莎拉。我们将探索iKinnect-SA作为移动医疗设备的监管路径，以实现食品和药物 在项目结束前获得美国食品和药物管理局(FDA)的批准，为第三阶段的成功商业化铺平道路。 该提案由三个项目阶段定义，其中包括：(1)概念验证形成 评估阶段，我们将迭代地设计、测试和构建原型(第一阶段；1-10个月)；(2) 产品设计和构建形成性评估阶段，在此阶段，我们将设计、构建和测试所有剩余的 功能和应用程序(第二阶段；11-22个月)；以及(3)涉及试点测试的总结性评估阶段 (n=25个二联体)和一个RCT(N=300个双联体)，将iKinnect-SA与结合了 IKinnect-SA与同行支持专家和主动控制条件应用程序(第二阶段；23-34个月)。

PROJECT SUMMARY/ABSTRACT Adolescent substance abuse (SA) has been called America’s #1 public health problem, affecting as many as 16% of all youth under age 18 and often resulting in serious consequences such as criminal involvement, health problems, and suicide. Given that adolescent SA is associated with high rates of comorbidity with mental health (MH) problems and increased suicide risk, integrated SA-MH treatment involving cognitive- behavioral and family therapy-based approaches, as well as early intervention, is critical. Yet few adolescents receive any treatment for SA, and unmet needs for services are likely to increase following COVID-19-related stressors, which disproportionately affected Black, Indigenous, and other youth of color. Developing culturally- appropriate mobile app technology to effectively address adolescent SA, MH symptoms, and suicide risk, delivering it in novel universal settings, and using direct-to-consumer and family peer support specialist techniques could potentially have a large-scale and highly cost-effective public health impact. iKinnect is a paired mobile app platform that supports parents (in delivering) and youth (in receiving) evidence-based practices to reduce youth problem behaviors. Based on Multisystemic Therapy principles, iKinnect1.0 was originally designed to help youth with serious conduct problems. Results from a randomized controlled trial (RCT; N=72) demonstrated its efficacy in reducing externalizing behaviors and improving parenting effectiveness in youth with serious conduct disorder. iKinnect is currently being adapted for more severely disordered suicidal youth involved in the juvenile justice system as well as their parents. We now seek to significantly adapt iKinnect for use with a general population of teens with problematic substance use and their parents to reduce SA, its harmful effects, opioid overdoses, and progression to substance use disorders, as well as other behavioral health problems that are exacerbated by SA and/or interfere with SA treatment. This 34-month fast track seeks to address SA and co-occurring MH problems in teens by significantly adapting iKinnect to deliver evidence-based SA and MH interventions to general-population youth engaging in SA. We will pursue regulatory pathways for iKinnect-SA as a mobile medical device to achieve Food and Drug Administration (FDA) approval by the project’s end to pave the way for successful Phase III commercialization. The proposal is defined by three project stages which include: (1) a proof-of-concept formative evaluation stage where we will iteratively design, test, and build a prototype (Phase I; Months 1-10); (2) a product design-and-build formative evaluation stage, where we will design, build, and test all remaining features and apps (Phase II; Months 11-22); and (3) a summative evaluation stage involving a pilot test (N=25 dyads) and a RCT (N=300 dyads) comparing iKinnect-SA to an enhanced condition that combines iKinnect-SA with Peer Support Specialists and an active control condition app (Phase II; Months 23-34).