Herrera Nancy, Cibrian Franceli L, Silva Lucas M, Beltran Jesus Armando, Schuck Sabrina E B, Hayes Gillian R, Lakes Kimberley D
Department of Psychiatry and Neuroscience, School of Medicine, University of California Riverside, 3390 University Ave., Suite 115, Riverside, CA 92501 USA.
Fowler School of Engineering, Chapman University, Orange, CA USA.
BMC Digit Health. 2024;2(1):78. doi: 10.1186/s44247-024-00134-4. Epub 2024 Nov 5.
Attention Deficit Hyperactivity Disorder (ADHD) is the most prevalent childhood psychiatric condition with profound public health, personal, and family consequences. ADHD requires comprehensive treatment; however, lack of communication and integration across multiple points of care is a substantial barrier to progress. Given the chronic and pervasive challenges associated with ADHD, innovative approaches are crucial. We developed the digital health intervention (DHI)-CoolTaCo [Cool Technology Assisting Co-regulation] to address these critical barriers. CoolTaCo uses Patient-Centered Digital Healthcare Technologies (PC-DHT) to promote co-regulation (child/parent), capture patient data, support efficient healthcare delivery, enhance patient engagement, and facilitate shared decision-making, thereby improving access to timely and targeted mental health intervention for children at significant risk for poor outcomes. The present paper will describe our planned protocol to evaluate the efficacy of CoolTaCo via randomized control trial (RCT).
METHODS/DESIGN: We will recruit 60 children (ages 8-12) with ADHD who will be randomized to either immediate ( = 30) or delayed ( = 30) treatment (i.e., a waitlist control group). Among those randomized to immediate treatment, half will be assigned to DHI (delivered via a smartwatch and smartphone application), the other half to an active control treatment as usual (TAU). Unlike the DHI group, the TAU group will receive the smartwatch with no assigned activities, applications, or interventions on the devices. The intervention period will last 16 weeks; after a participant has been in the delayed treatment group for 16 weeks and has completed the post-waiting period assessment, they will be randomly assigned to either the intervention or active control group. Thus, 30 participants will complete the intervention, and 30 will complete the active control, with half of the total sample completing a waitlist period.
Individuals with ADHD have complex needs. Despite improvement in outcomes following cognitive behavioral therapies (CBT) and pharmaceutical treatment, long-term maintenance is a challenge often not addressed by traditional medical approaches, and, as we described, ineffective approaches to information sharing across points of care create further barriers to progress. Our research will fill a significant gap in translating early treatment investments and gains into long-term, sustainable outcomes.This study was registered as a clinic trial at ClinicalTrials.gov (Digital Health Intervention for Children With ADHD, ID# NCT06456372) on 06/13/2024.
注意力缺陷多动障碍（ADHD）是最常见的儿童精神疾病，会对公众健康、个人及家庭造成严重影响。ADHD需要综合治疗；然而，多个医疗环节之间缺乏沟通与整合是治疗进展的重大障碍。鉴于ADHD相关的长期且普遍存在的挑战，创新方法至关重要。我们开发了数字健康干预措施（DHI）——CoolTaCo [酷技术辅助共同调节] 来应对这些关键障碍。CoolTaCo利用以患者为中心的数字医疗技术（PC-DHT）来促进共同调节（儿童/家长）、收集患者数据、支持高效医疗服务、增强患者参与度并促进共同决策，从而改善对结局不佳风险较高的儿童及时进行有针对性的心理健康干预的可及性。本文将描述我们计划通过随机对照试验（RCT）评估CoolTaCo疗效的方案。
方法/设计：我们将招募60名患有ADHD的儿童（8至12岁），他们将被随机分为立即治疗组（n = 30）或延迟治疗组（n = 30）（即等待名单对照组）。在随机分配到立即治疗的儿童中，一半将被分配到数字健康干预组（通过智能手表和智能手机应用程序提供），另一半接受常规积极对照治疗（TAU）。与数字健康干预组不同，常规积极对照治疗组将收到智能手表，但设备上没有指定的活动、应用程序或干预措施。干预期将持续16周；在参与者在延迟治疗组中待满16周并完成等待期后评估后，他们将被随机分配到干预组或积极对照组。因此，30名参与者将完成干预，30名将完成积极对照，总样本的一半将完成等待期。
患有ADHD的个体有复杂的需求。尽管认知行为疗法（CBT）和药物治疗后结局有所改善，但长期维持是传统医学方法往往未解决的挑战，而且，如我们所述，各医疗环节间无效的信息共享方式进一步阻碍了进展。我们的研究将填补在将早期治疗投入和成果转化为长期可持续结局方面的重大空白。本研究于2024年6月13日在ClinicalTrials.gov（ADHD儿童的数字健康干预，标识符#NCT06456372）注册为临床试验。
