Improving Health Outcomes for Orphans by Preventing HIV/STD Risk.

本R01提案的主要目标是通过一项随机对照试验（RCT），研究以创伤为重点的认知行为疗法（TF-CBT）治疗东非两个艾滋病高发地区——坦桑尼亚莫希（TZ）和肯尼亚邦戈马（KE）——的孤儿和青少年创伤性悲伤和创伤性应激的有效性。低收入和中等收入国家的精神卫生差距很大，需要治疗的人很少，甚至连基本护理都得不到。目前全世界的孤儿和青少年数量为1.43亿，仅撒哈拉以南非洲就有近5000万，其中1660万是由于艾滋病毒/艾滋病。这些是易受伤害的儿童，他们往往在父母死亡后出现精神健康问题，而且受到创伤的比例很高。在我们对坦桑尼亚孤儿的TF-CBT的可行性研究中，我们发现基于群体的TF-CBT干预是可行和可接受的，具有良好的临床效果。在可行性研究中，在我们的心理健康和TF-CBT专家团队的培训和监督下，没有任何心理健康经验的非专业咨询师进行了干预。在这一初步研究的基础上，我们提出了一项随机对照试验来测试TF-CBT治疗创伤性悲伤和创伤性压力的有效性，并将其与接受常规护理孤儿服务的TZ和KE进行比较。本研究在三个方面扩展了我们之前的工作：1)包括一个比较条件；2)包括两个国家，以审查更广泛的适用性和有效性；3)与可行性研究中经验丰富的外行咨询师合作，培训和监督外行咨询师，试图建立地方责任感，并采取措施实现可持续性。拟议的研究涉及与TZ和KE的艾滋病毒/艾滋病基层组织和当地共同调查员的合作，他们都是我们美国团队的长期合作者，位于城市和农村混合地区，允许在两个国家和两种环境（城市/农村）中检查有效性。采用任务转移方法，将非专业人员培训为咨询师，我们将在每个国家培训9名咨询师，他们将在每个站点提供20组咨询（10个农村，10个城市），从而使320名儿童和青少年（7-13岁）接受TF-CBT治疗，320名接受常规护理。儿童的结局在12-14周（即与TF-CBT结束相对应）、治疗后6个月和治疗后12个月进行评估。我们团队的TF-CBT专家与可行性研究的非专业咨询师（如当地培训师）合作培训TZ和KE咨询师，这些当地培训师在美国TF-CBT和心理健康专家的监督下进行TF-CBT监督。我们期望这项试验能够就孤儿的有效干预提出建议，这种干预是可接受的、可行的，并包括地方责任，作为提高LAMICs潜在可持续性的一种手段。调查结果将为其他努力提供信息，以扩大精神卫生干预措施，解决巨大的精神卫生差距。

DESCRIPTION (provided by applicant): Improving Outcomes for Orphaned Youth: Implementation of Trauma-focused CBT The primary goal of this R01 proposal is to study the effectiveness of Trauma-focused Cognitive Behavioral Therapy (TF-CBT) in treating traumatic grief and traumatic stress for orphaned children and young adolescents in two East African sites with high prevalence HIV, Moshi, Tanzania (TZ) and Bungoma, Kenya (KE), through a randomized controlled trial (RCT). The mental health gap in low and middle income countries (LAMICs) is substantial, with few individuals in need of treatment receiving even basic care. Orphaned children and adolescents currently number 143 million worldwide, with nearly 50 million in Sub-Saharan Africa alone, 16.6 million due to HIV/AIDS. These are vulnerable children, who often have mental health problems subsequent to parental death as well as high rates of trauma exposure. In our feasibility study of TF-CBT with orphans in Tanzania, we have found a group-based TF-CBT intervention to be feasible and acceptable, with promising clinical outcomes. In the feasibility study, lay counselors with no prior mental health experience delivered the intervention with training and supervision by our team of mental health and TF-CBT experts. Building on this initial study, we propose a RCT to test the effectiveness of TF-CBT for traumatic grief and traumatic stress compared to receipt of usual care orphan services in TZ and KE. The study extends our prior work in three ways: 1) includes a comparison condition; 2) includes two countries to examine broader applicability and effectiveness; and 3) involves partnering with the experienced lay counselors from the feasibility study to train and supervise lay counselors, in an attempt to build local responsibility and take steps toward sustainability. The proposed study involves collaboration with HIV/AIDS grassroots organizations and local Co-Investigators in TZ and KE, both of whom are longstanding collaborators with our US team and are located in mixed urban and rural areas, allowing examination of effectiveness in two countries and two settings (urban/rural). Using a task-shifting approach, in which lay individuals are trained as counselors, we will train nine counselors in each country, who deliver 20 groups in each site (10 rural, 10 urban), resulting in 320 children and adolescents (ages 7-13) who receive TF-CBT and 320 who receive usual care. Outcomes for children are assessed at 12-14 weeks (i.e., corresponding with the end of TF-CBT), 6-months post-treatment, and 12-months post-treatment. TF-CBT experts from our team partner with the lay counselors from the feasibility study (e.g., local trainers) to train the TZ ad KE counselors, and these local trainers provide the TF- CBT supervision, while supervised themselves by the US-based TF-CBT and mental health experts. We expect this trial to yield recommendations regarding an effective intervention for orphans that is acceptable, feasible, and includes local responsibility as a means to enhance potential sustainability in LAMICs. Findings will inform other efforts to scale up mental health interventions to address the substantial mental health gap. PUBLIC HEALTH RELEVANCE: The primary goal of this R01 proposal is to study the effectiveness of Trauma-focused Cognitive Behavioral Therapy (TF-CBT) for treating unresolved grief and traumatic stress for orphaned children and adolescents in two East African countries, Tanzania and Kenya. The mental health gap is substantial, with few individuals in need of treatment receiving even minimal supports. Among those in need, orphaned children and adolescents, who currently number 143 million worldwide, with nearly 50 million in Sub-Saharan Africa alone, often have mental health problems subsequent to parental loss.