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

资源匮乏的初级保健机构中针对青少年焦虑和抑郁的行为远程医疗：一项随机有效性实施研究

• 批准号: 10731716
• 负责人: FRANCES L LYNCH
• 金额: $ 107.07万
• 依托单位: SAN DIEGO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-21 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10731716
• 关键词: Adopted; Affect; Aftercare; Age; Anxiety; Anxiety Disorders; Area; Behavior Therapy; Behavioral; Caring; Clinic; Clinical; Clinical effectiveness; Communities; Community Mental Health Services; Community Practice; Community Surveys; Consolidated Framework for Implementation Research; Data; Depressed mood; Development; Diagnostic; Disadvantaged; Disease; Effectiveness; Electronic Health Record; Eligibility Determination; Etiology; Face; Family; Funding; Future; Housing; Hybrids; Impairment; Implementation readiness; Intake; Intervention; Interview; Language; Latinx; Lead; Leadership; Masks; Mediating; Mental Depression; Mental Health; Mental Health Services; Modeling; Modification; Mood Disorders; Neighborhood Health Center; Outcome; Patients; Pediatrics; Pilot Projects; Population; Population Heterogeneity; Predictive Factor; Primary Care; Process; Provider; Quality of Care; Randomized; Readiness; Recurrence; Reporting; Resource-limited setting; Resources; Risk; Sampling; Site; Suicide; Surveys; Technology; Testing; Translations; Vulnerable Populations; Work; Youth; acceptability and feasibility; anxiety treatment; anxious; arm; avoidance behavior; comorbidity; cost effective; cost effectiveness; cost estimate; cost per quality-adjusted life year; digital health; disparity reduction; effective therapy; effectiveness testing; effectiveness-implementation randomized trial; effectiveness/implementation study; evidence base; experience; follow-up; functional disability; future implementation; health care disparity; health service use; implementation efforts; implementation evaluation; implementation framework; implementation trial; improved; incremental cost-effectiveness; innovation; minority children; primary care setting; programs; public health priorities; recruit; response; safety net; social health determinants; telehealth; tool; treatment program; treatment research

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).

拟议的混合 1 型随机有效性实施试验将探讨简短的效果 对资源匮乏的患有焦虑和/或抑郁症的青少年进行行为治疗 (STEP-UP) 初级保健社区卫生中心 (CHC) 为不同群体的弱势家庭提供服务。 青少年中焦虑和情绪障碍很普遍，并且会造成损害，当前和终生合并症很高 部分是由于共同的病因造成的。如果不治疗，这些疾病会导致持续的功能障碍 表明复发性疾病和自杀的风险增加。只有五分之一的青少年表示焦虑，五分之二的青少年表示抑郁 任何终生心理健康用途，任何青少年心理健康状况的最低治疗率。此外， 护理方面存在显着差异，家庭面临着较高的健康社会决定因素 (SDOH) 负担和少数族裔青年获得心理健康服务的可能性明显低于类似受影响的青年，但 弱势群体较少，年轻人。此外，在 CHC 等安全网环境中接受服务的家庭通常 经历循证护理的多重交叉风险和障碍。因此，有效的治疗 焦虑和抑郁的缓解是一项重要的公共卫生优先事项，特别是对于传统上服务不足的人来说 年轻人。 STEP-UP 是一种简化的跨诊断行为干预措施，旨在有效治疗焦虑症 通过针对两种疾病类别共有的回避行为，将抑郁症作为一个统一的问题领域。 拟议的研究建立在一项成功的多地点随机对照试验 STEP-UP 的基础上，该随机对照试验基于初级保健，并有被保险人 青年人口。为了增加资源匮乏的社区卫生中心的传播潜力，我们调整了该计划 从面对面的形式到数字健康框架，并开发了西班牙语翻译。飞行员 对STEP-UP修订版的研究已显示出可行性和可接受性；然而，临床数据 在这个新环境（CHC）和样本（高 SDOH 风险）中仍需要有效性。因此，我们建议 进行一项创新的、为期 5 年的混合有效性实施研究（类型 1），严格测试 STEP-UP 数字健康版本的临床有效性，同时收集数据以制定计划 未来 CHC 实施试验。青少年（8.0-16.5岁，N=220）将通过以下方式确定和招募： 电子健康记录 (EHR) 和临床医生转诊。符合资格的青少年将被随机分配到 (a) STEP-UP 或 (b) 促进转介至社区中的 TAU (TAU+)。临床有效性将通过掩蔽评估 独立评估员在 STEP-UP 治疗后（第 16 周）和随访时（第 32 周）进行评估。执行 数据将来自：(a) 对 CHC 领导者的调查，(b) 对 STEP-UP 临床医生的调查和访谈， (c) EHR 和 CHC 管理数据。具体目标包括测试 STEP-UP 的临床有效性 干预机制的参与（目标 1）、探索成本效益（目标 2）、测试 SDOH 预测因子和调节因子来评估效果的稳健性（目标 3），并确定目标机制 使用实施研究综合框架（目标 4）进行未来的实施试验。