Reach and Scalability of Digital Therapeutics for Childhood Behavior Problems

项目摘要/摘要 尽管循证治疗(EBTS)已经被开发出来用于儿童行为问题，但许多 家庭无法获得这些服务。访问障碍包括服务的本地可用性， 交通、成本和被认为是耻辱。在这个项目中，我们的目标是测试移动医疗的有效性 (MHealth)系统作为独立干预与教练辅助干预，其目标是实现覆盖范围和 可扩展性。该项目将包括一项随机对照试验，以研究名为UseIt！的移动健康系统的有效性。 (利用技能增强治疗的影响)远程提供治疗并促进使用 家长管理培训(PMT)技能和认知行为治疗(CBT)技能。使用它！是该计划的一部分 数字治疗领域的发展，基于电子设备可以增强健康的概念 结果和降低成本。有破坏性行为(N=324个二元)的儿童(5-8岁)的父母将是 随机分配到组1(独立APP；n=108)、组2(教练辅助APP；n=108)或组3 (对照APP；n=108)。结果评估(治疗后和6个月随访)将包括 目标参与度(PMT/CBT技能获取和利用)和症状减轻的措施。本RCT 采用实验性治疗学方法，旨在测量目标参与度以确定 目标参与度是否与症状减轻相关。目标是PMT/CBT技能获取 和利用率。这些领域的技能不足被理解为严重破坏性的关键维持因素 行为问题。目标1是评估使用它的有效性！移动健康系统既是独立的 以及教练辅助干预与对照应用程序的情况进行比较。目标2是评估目标(PMT/CBT技能 获取和利用)接洽和验证。目标3是评估该计划的有效性 UseIt的组件！移动健康系统。该项目有可能对这两个科学领域产生影响 知识和临床实践。在科学知识方面，该项目有潜力扩大我们的 对靶机制的理解。通过纳入可靠和有效的治疗目标措施， 无论临床结果如何，该项目都将是信息丰富的。在临床实践方面，数字治疗学 有可能加强以技能为基础的心理社会干预的覆盖面和可扩充性。即使是小的 如果干预措施可以很容易地大规模交付，那么在人口层面上的影响可能是有意义的 低成本。该项目与NICHD的使命是一致的，即确保所有儿童都有机会实现 他们为健康和富有成效的生活发挥了全部潜力。

Project Summary/Abstract Although evidence-based treatments (EBTs) have been developed for childhood behavior problems, many families do not have access to these services. Barriers to access include local availability of services, transportation, cost, and perceived stigma. In this project, we aim to test the effectiveness of a mobile health (mHealth) system as a standalone versus coach-assisted intervention with the goal of achieving reach and scalability. The project will consist of an RCT to study the effectiveness of an mHealth system called UseIt! (Utilizing Skills to Enhance the Impact of Treatment) to deliver treatment remotely and promote the use of parent management training (PMT) skills and cognitive-behavioral therapy (CBT) skills. UseIt! is part of the growing field of digital therapeutics, based on the concept that electronic devices can enhance health outcomes and reduce costs. Parents of children (ages 5-8) with disruptive behaviors (N = 324 dyads) will be randomly assigned to Group 1 (standalone app; n = 108), Group 2 (coach-assisted app; n = 108), or Group 3 (control app; n = 108). The outcome assessments (post-treatment and 6-month follow-up) will include measures of target engagement (PMT/CBT skill acquisition and utilization) and symptom reduction. This RCT takes an experimental therapeutics approach and is designed to measure target engagement to determine whether target engagement is associated with symptom reduction. The targets are PMT/CBT skill acquisition and utilization. Skill deficits in these domains are understood as key maintaining factors for serious disruptive behavior problems. Aim 1 is to evaluate the effectiveness of the UseIt! mHealth system as both a standalone and coach-assisted intervention compared to a control app condition. Aim 2 is to assess target (PMT/CBT skill acquisition and utilization) engagement and validation. Aim 3 is to evaluate the effectiveness of the components of the UseIt! mHealth system. The project has the potential to make an impact on both scientific knowledge and clinical practice. In terms of scientific knowledge, the project has the potential to expand our understanding of target mechanisms. By incorporating reliable and valid measures of the treatment targets, the project will be informative regardless of the clinical outcome. In terms of clinical practice, digital therapeutics has the potential to enhance the reach and scalability of skills-based psychosocial interventions. Even small effects can be meaningful on a population level if the intervention can be delivered easily on a large scale at low cost. The project is consistent with NICHD’s mission to ensure “that all children have the chance to achieve their full potential for healthy and productive lives.”