iKinnect Mobile Technology to Reduce Teen Substance Misuse and Health Disparities

iKinnect 移动技术可减少青少年药物滥用和健康差异

• 批准号: 10545162
• 负责人: Linda A Dimeff
• 金额: $ 31.97万
• 依托单位: EVIDENCE-BASED PRACTICE INSTITUTE, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10545162
• 关键词: Address; Adolescent; Affect; Age; Behavioral; Black race; COVID-19; Caregiver support; Caring; Child Rearing; Cognitive Therapy; Conduct Disorder; Development; Disease; Distress; Early Intervention; Effectiveness; Ensure; Evaluation; Evidence based intervention; Evidence based practice; Family; Family psychotherapy; Feedback; General Population; Health; Indigenous; Intervention; Manuals; Marketing; Measures; Medical Device; Mental Health; Methods; Outcome; Parents; Participant; Phase; Population; Problem behavior; Procedures; Process; Public Health; Randomized, Controlled Trials; Readiness; Regulatory Pathway; Reporting; Research; Risk Behaviors; Sales; Self-Injurious Behavior; Services; Specialist; Stress; Substance Use Disorder; Substance abuse problem; Suicide; Symptoms; Systemic Therapy; Techniques; Technology; Teenagers; Testing; United States Food and Drug Administration; Youth; active control; adolescent substance abuse; behavioral health; children of color; commercialization; commercialization readiness; comorbidity; comparison control; conduct problem; coping; coronavirus disease; cost effective; design; design,build,test; digital technology; evidence base; experience; externalizing behavior; formative assessment; health disparity; ideation; improved; iterative design; juvenile justice system; meetings; mobile application; mobile computing; novel; opioid overdose; peer support; pilot test; prevent; prototype; recruit; reduced substance abuse; reduced substance use; satisfaction; smartphone application; stressor; substance abuse treatment; substance misuse; substance use; suicidal adolescent; suicidal behavior; suicidal morbidity; suicidal risk; suicide rate; trial design; user centered design

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).

项目总结/摘要 青少年药物滥用（SA）被称为美国的头号公共卫生问题，影响到许多人。 占18岁以下青少年的16%，往往导致严重后果，如犯罪， 健康问题和自杀。鉴于青少年SA与高并发症率相关， 心理健康（MH）问题和自杀风险增加，综合SA-MH治疗涉及认知- 基于行为和家庭治疗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，并且在COVID-19相关之后，未满足的服务需求可能增加 压力，这不成比例地影响了黑人，土著和其他有色人种的青年。文化发展- 适当的移动的应用程序技术，以有效地解决青少年SA，MH症状和自杀风险， 在新颖的通用环境中提供，并使用直接面向消费者和家庭同伴支持专家 这些技术有可能对公共卫生产生大规模和高成本效益的影响。 iKinetics是一个配对的移动的应用程序平台，支持父母（在交付）和青年（在接收） 以证据为基础的做法，以减少青年问题行为。基于多系统治疗原则， iKinnect1.0最初是为了帮助有严重行为问题的青少年。结果来自随机 对照试验（RCT; N=72）证明了其在减少外化行为和改善 严重品行障碍青少年的父母教养效能iKinetics目前正在适应更多 青少年司法系统中涉及的严重精神错乱的自杀青年以及他们的父母。我们现在寻求 显著调整iKinetron用于有问题的物质使用的青少年的一般人群， 他们的父母减少SA，其有害影响，阿片类药物过量，以及物质使用障碍的进展， 以及其它由SA加重和/或干扰SA治疗的行为健康问题。 这34个月的快速通道旨在解决SA和共同发生的MH问题，在青少年显着 调整iKinetics，为从事以下活动的普通人群青年提供基于证据的SA和MH干预措施： SA.我们将寻求iKinnect-SA作为一种移动的医疗器械的监管途径，以实现食品和药品监督管理局（FDA） 美国食品和药物管理局（FDA）的批准，该项目的结束，铺平了道路，成功的第三阶段商业化。 该提案被定义为三个项目阶段，其中包括：（1）概念验证形成 评估阶段，我们将迭代设计，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，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对）和一项RCT（N=300对），比较iKinnect-SA与一种增强型疾病， iKinnect-SA与同伴支持专家和主动控制条件应用程序（第二阶段;第23-34个月）。