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 全球有1600多万孤儿和弱势儿童(OVC)，估计在1.9-370万人之间 100万美元用于南非(SA)。尽管OVC对心理健康有很高的需求，但精神短缺存在危机 南澳的卫生工作者。社区组织(CBO)提供了一个战略干预点。在前一次 美国国立卫生研究院资助的准实验可行性试验表明，中介干预为致敏 CBO照顾者(MISC)，此后被命名为MISC-CBO，显著降低了精神健康 说塞索托语的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照顾者的照看能力以改善儿童结果的干预措施，方法是 针对RDoC系统的社交流程(从属关系和依恋)。在这项工作的基础上，我们现在 提出重复测量整群随机试验，充分确立有效性和跨诊断性 MISC-CBO在7-11岁儿童中的作用机制--建立心理健康的关键发展阶段 对青春期精神问题的复原力。此外，我们还将使用整合框架 用于实施研究(CFIR)的构造和来自社区咨询委员会(CAB)的输入以利用 评估执行成本、气候和准备情况的区域工作队，以更好地定位区域工作队的成果 未来的吸纳、规模扩大和可持续性。在目标1中，我们将评估MISC-CBO对视频的直接影响- 编码CBO照顾者照看质量(从属关系和依恋)与儿童心理健康结果 在24个月内。将利用我们现有的非政府组织招聘24名社区干事(360名儿童和72名护理员) 合作伙伴(Childline)在自由州的Mangaung和Xhariep区，SA。CBO将随机分配 接受为期一年的双周MISC-CBO或TAU。我们假设MISC-CBO将与 随着护理人员护理质量的相对提高和OVC精神健康问题的减少。 在目标2a中，我们将检验这一假设，即干预结束时(12个月)的护理质量占 干预对18个月和24个月儿童心理健康的影响目标2b将评估的缓和效果 孤儿状况和家庭环境的质量，期待OVC是母亲和双胞胎 孤儿和来自贫困家庭环境的人对干预的反应将比 没有这些危险因素的儿童。Aim 3a将使用世界卫生组织的衡量标准来检验这一假设 MISC-CBO在避免残疾调整寿命年(DALY)方面具有成本效益。目标3b将使用定性 检验社区利益相关者认为气候有利并为 实施MISC-CBO，以及扩大和实施其他障碍和促进者将 被指认出来。我们提议的工作将我们的形成性工作扩展到现在完全测试现实世界的有效性， MISC-CBO在关键时期的行动机制、成本效益和实施准备情况 高危儿童进入青春期的发展窗口，与NIMH的战略目标一致。