Behavioral telehealth in low-resource primary care settings for anxiety and depression in youth: A randomized effectiveness-implementation study

拟议的混合类型1随机有效性-实施试验将探索 从低资源招募的患有焦虑和/或抑郁的青少年的行为疗法(Step-Up) 初级保健社区卫生中心(CHC)，为弱势家庭的不同人群提供服务。 焦虑和情绪障碍在青年中普遍存在，并造成损害，目前和终生共病高。 部分原因是共同的病因。如果不治疗，这些疾病会导致持续性的功能障碍和 会增加疾病复发和自杀的风险。只有五分之一的焦虑和五分之一的抑郁青年报告 任何终生精神健康使用，是任何青少年精神健康状况的最低治疗率。此外, 在护理方面存在显著差异，家庭经历了高社会健康决定因素(SDOH) 负担和少数族裔青年接受心理健康服务的可能性明显低于类似受影响的人，但 更少的劣势，年轻人。此外，在社区卫生中心等安全网环境中接受服务的家庭通常 体验循证护理的多重交叉风险和障碍。因此，有效的治疗 焦虑和抑郁是一个关键的公共卫生优先事项，特别是对于传统上服务不足的人 年轻人。Step-Up是一种简化的跨诊断行为干预方法，旨在有效地治疗焦虑 而抑郁症作为一个统一的问题领域，通过瞄准这两个障碍类别共同的回避行为。 这项拟议的研究建立在一项成功的基于初级保健的多点随机对照试验的基础上，被保险人 年轻人的人口。为了增加对低资源社区卫生保健中心的传播潜力，我们对该计划进行了调整 从面对面的形式到数字保健框架，并开发了西班牙语翻译。引航员 对这个修订版本的Step-Up的研究已经表明了可行性和可接受性；然而，临床数据 在这种新的环境(CHC)和样本(SDOH风险较高)中仍然需要有效性。因此，我们建议 进行为期5年的创新混合有效性-实施研究(类型1)，严格测试 数字健康版Step-Up的临床效果，同时收集数据计划 未来的CHC实施试验。将通过以下途径确定和招募青年(8.0-16.5岁，N=220) 电子健康记录(EHR)和临床医生转介。符合条件的青年将被随机分成(A)升级班或 (B)促进社区内转诊至TAU(TAU+)。临床疗效将通过蒙面进行评估 独立评估者在加强治疗后(第16周)和后续行动(第32周)。实施 数据将来自：(A)对CHC领导人的调查，(B)对加强临床医生的调查和访谈， 和(C)EHR和CHC管理数据。具体目标包括测试Step-Up的临床有效性 和参与干预机制(目标1)、探索成本效益(目标2)、测试SDOH 评估效果稳健性的预报器和协调器(目标3)，并确定目标机制 今后使用执行研究综合框架进行的执行试验(目标4)。

The proposed hybrid type 1 randomized effectiveness-implementation trial will probe the effects of brief behavioral therapy (STEP-UP) for youths with anxiety and/or depression recruited from low-resource primary care community health centers (CHCs) that serve a diverse population of vulnerable families. Anxiety and mood disorders in youth are prevalent and impairing, with high current and lifetime comorbidity in part due to shared etiologic factors. Untreated, these disorders lead to sustained functional impairment and convey increased risk for recurrent disorder and suicide. Only 1 in 5 anxious and 2 in 5 depressed youth report any lifetime mental health use, the lowest treatment rates for any youth mental health condition. In addition, there are notable disparities in care, with families experiencing high social determinants of health (SDOH) burden and minority youths significantly less likely to receive mental health services than similarly affected, but less disadvantaged, youths. Further, families who are served in safety-net settings such as CHCs often experience multiple, intersectional risks and barriers to evidence-based care. Therefore, effective treatment of anxiety and depression is a critical public health priority, especially for traditionally underserved youths. STEP-UP is a streamlined transdiagnostic behavioral intervention developed to efficiently treat anxiety and depression as a unified problem area by targeting avoidance behavior common to both disorder classes. The proposed study builds on a successful multi-site RCT of STEP-UP based in primary care with an insured population of youths. To increase dissemination potential to low-resource CHCs, we have adapted the program from a face-to-face format to a digital health framework and developed a Spanish-language translation. Pilot studies of this revised version of STEP-UP have shown feasibility and acceptability; however, data on clinical effectiveness are still needed in this new setting (CHC) and sample (high SDOH risk). Thus, we propose to conduct an innovative, 5-year hybrid effectiveness-implementation study (Type 1) rigorously testing the clinical effectiveness of the digital health version of STEP-UP, while simultaneously collecting data to plan future CHC implementation trials. Youths (age 8.0-16.5, N=220) will be identified and recruited through electronic health records (EHR) and clinician referral. Eligible youths will be randomized to (a) STEP-UP or (b) facilitated referral to TAU in the community (TAU+). Clinical effectiveness will be assessed by masked independent evaluators at STEP-UP post-treatment (Week 16) and at follow-up (Week 32). Implementation data will be pulled from: (a) surveys of CHC leaders, (b) surveys of and interviews with STEP-UP clinicians, and (c) EHR and CHC administrative data. Specific aims include testing the clinical effectiveness of STEP-UP and engagement of the intervention mechanism (Aim 1), probing cost effectiveness (Aim 2), testing SDOH predictors and moderators to evaluate robustness of effects (Aim 3), and identifying target mechanisms for future implementation trials using the Consolidated Framework for Implementation Research (Aim 4).