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).

拟议的杂种1型随机有效性实施试验将探究简短的影响 从低资源招募的焦虑和/或抑郁症的年轻人的行为疗法（升级） 初级保健社区卫生中心（CHC）为各种各样的弱势家庭提供服务。 年轻人的焦虑和情绪障碍是普遍且受损的，高电流和终身合并症 部分是由于共同的病因因素。这些疾病未经治疗，导致功能障碍和 传达增加复发性疾病和自杀的风险。五分之一的焦虑中只有1个，五分之一的青年报告中只有1个 任何终生的心理健康使用，是任何青年心理健康状况的最低治疗率。此外， 护理中存在显着差异，家庭经历了健康的高度决定因素（SDOH） 与受到的影响相比 年轻人不利。此外，经常在CHC等安全网环境中服务的家庭 体验多个，交叉的风险和循证护理的障碍。因此，有效的治疗 焦虑和抑郁是关键的公共卫生优先事项，尤其是对于传统服务不足 年轻人。升级是一种简化的经诊断行为干预措施，以有效治疗焦虑 通过针对两种疾病类别共同的回避行为，抑郁作为统一问题领域。 拟议的研究基于基于初级保健的成功多站点的RCT，并有被保险人 年轻人的人口。为了增加对低资源CHC的传播潜力，我们已经改编了该计划 从面对面的格式到数字健康框架，并开发了西班牙语翻译。飞行员 对这种修订版的升级版本的研究表明，可行性和可接受性。但是，有关临床的数据 在这种新环境（CHC）和样本（高SDOH风险）中，仍然需要有效性。因此，我们建议 进行创新的5年混合有效性研究研究（1型）严格测试 数字健康版的升级版本的临床有效性，同时收集数据进行计划 未来的CHC实施试验。年轻人（8.0-16.5，n = 220）将被识别和招募 电子健康记录（EHR）和临床医生转诊。符合条件的年轻人将被随机分配到（a）加速或 （b）促进社区中tau的推荐（tau+）。临床有效性将通过蒙版评估 升级后的独立评估者（第16周）和随访（第32周）。执行 数据将从：（a）对CHC领导者的调查，（b）调查和对升级临床医生的访谈， （c）EHR和CHC管理数据。具体目的包括测试升级的临床有效性 和干预机制的参与度（AIM 1），探测成本效益（AIM 2），测试SDOH 预测因素和主持人评估效果的鲁棒性（AIM 3），并确定目标机制 使用合并框架进行实施研究的未来实施试验（AIM 4）。