MISC-CBO: A cluster randomized control trial to improve the mental health of OVC in South Africa

MISC-CBO：旨在改善南非 OVC 心理健康的整群随机对照试验

• 批准号: 10509789
• 负责人: CARLA SHARP
• 金额: $ 36.45万
• 依托单位: UNIVERSITY OF HOUSTON
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10509789
• 关键词: 11 year old; AIDS/HIV problem; Address; Adolescence; Adolescent; Age; Aging; Books; Caregivers; Cessation of life; Characteristics; Child; Child Development; Child Mental Health; Chronic Disease; Climate; Cluster randomized trial; Code; Communities; Consolidated Framework for Implementation Research; Development; Diagnostic; Dimensions; Education; Effectiveness; Environment; Epidemic; Family; Feedback; Female; Focus Groups; Funding; Future; Goals; Government; Home; Home environment; Human Resources; Implementation readiness; Imprisonment; Individual; Infrastructure; Intervention; Malnutrition; Measures; Mediating; Mediator of activation protein; Mental Health; Methodology; Methods; Names; National Institute of Mental Health; Orphan; Outcome; Parents; Population; Positioning Attribute; Poverty; Prevention; Psyche structure; Psychology; Psychopathology; Public Health; Randomized; Randomized Controlled Trials; Readiness; Research; Research Domain Criteria; Resource-limited setting; Risk; Risk Factors; Social Processes; South Africa; State Government; Structure; Symptoms; System; Testing; Uganda; United States National Institutes of Health; Universities; Work; World Health Organization; base; caregiving; civil society; comparative; comparison intervention; cost effective; cost effectiveness; cost-effectiveness evaluation; disability; disability-adjusted life years; disorder risk; empowered; evidence base; feasibility trial; follow-up; high risk; implementation cost; implementation evaluation; improved; informant; intervention effect; neglect; post intervention; programs; public health intervention; public health relevance; recruit; resilience; response; scale up; severe mental illness; skills; substance abuser; therapy design; uptake

ABSTRACT Globally, there are over 16 million orphans and vulnerable children (OVC), with estimates of between 1.9-3.7 million for South Africa (SA). Despite high mental health needs of OVC, there is a crisis in scarcity of mental health workers in SA. Community-based organizations (CBOs) offer a strategic point of intervention. In a prior NIH-funded quasi-experimental feasibility trial we showed that the Mediational Intervention for Sensitizing Caregivers (MISC) for CBO careworkers, thereafter named MISC-CBO, significantly reduced mental health problems in Sesotho-speaking OVC. MISC-CBO is a year-long semi-structured, manualized video-feedback intervention designed to enhance the caregiving capacity of CBO careworkers to improve child outcomes, by targeting the RDoC systems for social processes (affiliation and attachment). Building on this work, we now propose a repeated measures cluster randomized trial to fully establish the effectiveness and trans-diagnostic mechanisms of action of MISC-CBO in 7-11 year olds – a developmental stage critical for building mental health resilience against the adolescent onset of psychiatric problems. In addition, we will use Consolidated Framework for Implementation Research (CFIR) constructs and input from a Community Advisory Board (CAB) to leverage the RCT to evaluate implementation costs, climate and readiness that would better position the RCT results for future uptake, scale up, and sustainability. In Aim 1, we will evaluate the direct effects of MISC-CBO on video- coded CBO careworker caregiving quality (affiliation and attachment) and children’s mental health outcomes over a 24 month period. 24 CBOs (360 children and 72 careworkers) will be recruited using our existing NGO partner (Childline) in the Mangaung and Xhariep districts in the Free State, SA. CBOs will be randomly assigned to receive either one year of bi-weekly MISC-CBO or TAU. We hypothesize that MISC-CBO will be associated with comparative increases in careworker caregiving quality and reductions in mental health problems in OVC. In Aim 2a, we will test the hypothesis that caregiving quality at end-of-intervention (12 months) accounts for intervention effects on child mental health at 18 and 24 months. Aim 2b will evaluate the moderating effects of orphan status and the quality of the home environment, expecting that OVC who are maternal and double orphans, and from impoverished home environments will show reduced response to intervention compared to children without these risk factors. Aim 3a will use World Health Organization metrics to test the hypothesis that MISC-CBO is cost-effective in terms of disability-adjusted life years (DALYs) averted. Aim 3b will use qualitative methodology to test the hypothesis that community stakeholders deem the climate favorable and ready for the implementation of MISC-CBO, and that additional barriers and facilitators for scale-up and implementation will be identified. Our proposed work extends our formative work to now fully test the real-world effectiveness, mechanisms of action, cost-effectiveness and implementation readiness of MISC-CBO during the critical developmental window of at-risk children aging into adolescence, consistent with NIMH’s strategic objectives.

摘要 在全球范围内，有超过1600万孤儿和弱势儿童（OVC），估计在1.9-3.7之间。 南非（SA）。尽管孤儿和易受感染儿童的心理健康需求很高，但心理健康缺乏的危机仍然存在。 卫生工作者在SA。社区组织提供了一个战略干预点。在现有 NIH资助的准实验可行性试验表明， CBO护理人员的护理人员（MISC），此后被命名为MISC-CBO，显着降低了心理健康 塞索托语OVC的问题。MISC-CBO是一个为期一年的半结构化，手动视频反馈 旨在提高CBO护理人员的咨询能力以改善儿童结局的干预措施， 将RDoC系统定位于社会过程（联系和依恋）。在此基础上，我们现在 提出一项重复措施的集群随机试验，以充分确定有效性和跨诊断 MISC-CBO在7-11奥尔兹中的作用机制-这是建立心理健康的关键发展阶段 对青少年精神问题的恢复力。此外，我们将使用统一框架 实施研究（CFIR）的结构和社区咨询委员会（CAB）的输入，以利用 RCT评估实施成本、气候和准备情况，以更好地定位RCT结果， 未来的吸收、扩大规模和可持续性。在目标1中，我们将评估MISC-CBO对视频的直接影响- 编码CBO照顾者的工作质量（关系和依恋）和儿童的心理健康结果 在24个月的时间里。将利用我们现有的非政府组织招募24名社区组织（360名儿童和72名护理人员） 在南澳大利亚州自由州的Mangaung和Xhariep地区建立了合作伙伴（儿童热线）。社区组织将被随机分配 接受为期一年的每两周一次的MISC-CBO或TAU。我们假设MISC-CBO将与 护理人员的工作质量相对提高，孤儿和易受感染儿童的心理健康问题减少。 在目标2a中，我们将检验干预结束时（12个月）的学习质量是否能解释 干预对18和24个月儿童心理健康的影响。目标2b将评估以下因素的调节作用： 孤儿身份和家庭环境的质量，期望孤儿谁是母亲和双 孤儿和来自贫困家庭环境的儿童， 没有这些危险因素的孩子。目标3a将使用世界卫生组织的指标来检验以下假设： 就避免的残疾调整生命年而言，MISC-CBO具有成本效益。目标3b将使用定性 一种方法来测试假设，即社区利益相关者认为气候有利，并准备 执行MISC-CBO，以及扩大和执行的额外障碍和促进因素， 被识别。我们提出的工作扩展了我们的形成性工作，现在完全测试了现实世界的有效性， 关键时期的行动机制、成本效益和执行准备情况 发展窗口的风险儿童进入青春期，符合NIMH的战略目标。