Reach and Scalability of Digital Therapeutics for Childhood Behavior Problems

儿童行为问题数字疗法的覆盖范围和可扩展性

• 批准号: 10515060
• 负责人: OLIVER JAMES LINDHIEM
• 金额: $ 65.66万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10515060
• 关键词: Aftercare; Age; Behavior; Cellular Phone; Child; Child Rearing; Childhood; Clinical; Clinical Trials; Cognitive Therapy; Effectiveness; Electronics; Ensure; Evidence based treatment; Failure; Family; Foundations; Funding; Goals; Grant; Health; Health Services Accessibility; Health system; Intervention; Investigational Therapies; Knowledge; Libraries; Link; Measures; Mission; National Institute of Child Health and Human Development; Outcome; Outcome Assessment; Parents; Population; Problem behavior; Randomized; Randomized Controlled Trials; Symptoms; Therapeutic; Training; Transportation; Treatment Failure; United States National Institutes of Health; Validation; Work; base; clinical practice; cognitive training; comparison intervention; cost; design; diaries; digital treatment; effectiveness evaluation; effectiveness study; effectiveness testing; follow-up; mHealth; pilot trial; psychosocial; reduce symptoms; remote therapy; satisfaction; scale up; skill acquisition; skills; skills training; social stigma; web portal

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.”

项目总结/摘要 虽然循证治疗（EBT）已经开发了儿童行为问题，许多 家庭无法获得这些服务。获得服务的障碍包括当地服务的可获得性， 交通，成本和感知的耻辱。在这个项目中，我们的目标是测试一个移动的健康的有效性 （mHealth）系统作为独立干预与教练辅助干预的比较，目标是实现覆盖范围和 可伸缩性该项目将包括一个随机对照试验，以研究一个名为“移动健康”的系统的有效性。 （利用技能提高治疗效果）远程提供治疗，并促进使用 父母管理培训（PMT）技能和认知行为治疗（CBT）技能。别这样！隶属于the 数字治疗领域的不断发展，基于电子设备可以增强健康的概念 成果和降低成本。有破坏性行为的儿童（5-8岁）的父母（N = 324对）将被 随机分配至组1（独立应用程序; n = 108）、组2（教练辅助应用程序; n = 108）或组3 （对照app; n = 108）。结局评估（治疗后和6个月随访）将包括 目标参与（PMT/CBT技能获取和利用）和症状减轻的措施。本RCT 采用实验性治疗方法，旨在测量目标参与，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。这些领域的技能缺陷被认为是严重破坏性行为的关键维持因素。 行为问题目的1是评估的有效性，它的竞争力！mHealth系统作为一个独立的 和教练辅助干预相比，控制应用程序的条件。目标2是评估目标（PMT/CBT技能 获取和利用）参与和验证。目标3是评估 的组成部分！mHealth系统。该项目有可能对科学和技术产生影响， 知识和临床实践。在科学知识方面，该项目有可能扩大我们的 了解目标机制。通过纳入治疗目标的可靠和有效措施， 无论临床结果如何，项目都将提供信息。在临床实践方面，数字治疗 有可能扩大以技能为基础的心理社会干预的范围和规模。即使是小 如果干预措施可以很容易地大规模实施， 低成本该项目符合NICHD的使命，即确保“所有儿童都有机会实现 他们健康和富有成效的生活的全部潜力。”