A brief, task-shifted treatment to improve father depression and child outcomes in Kenya: A pilot effectiveness-implementation trial

项目总结 在全球范围内，抑郁症是世界各地导致残疾的主要原因，但超过75%的低收入和低收入人群 中等收入国家(LMIC)不接受治疗。对于男性来说，这一差距尤其大。治疗男人是 考虑到抑郁症对患有男性抑郁症的家庭和儿童的影响，这对于减轻全球抑郁症负担至关重要 心理健康(MH)预测不良的父母教养方式和儿童MH。尽管治疗父母抑郁一直是 显示改善了父母的MH、育儿和儿童的MH；男人和父亲一直缺少MH的护理和 临床试验。与父亲有关的卫生保健，解决了卫生保健的常见障碍，如男性规范和 经济因素，是必要的。K23的目标是扩展候选人的技能集，并为她做好准备 开展针对成人MH的可扩展干预措施的独立研究，以改善资源匮乏的儿童MH 设置。通过课程作业和研讨会、科学会议、协作 出版物，以及来自顶尖专家的指导，候选人将在1)执行方面培养能力 使用实施科学设计的随机对照试验；2)探讨MH的变化机制 使用混合方法；3)了解实施健康的社会决定因素(SDH)。 应聘者将运用通过培训获得的知识和技能进行随机试验 在肯尼亚使用有效性实施设计的对照试验(RCT)。候选人将利用现有的 与肯尼亚AMPATH和MOI教学和转诊医院(MTRH)建立伙伴关系。她还将在 与AMPATH/MTRH合作的初步工作，显示出有希望的概念验证， 参与、奉献(Lead)，这是一种5次任务转移的行为激活干预，具有激励性 访谈和讨论肯尼亚父亲的男子汉气概策略。九项概念验证调查结果 父亲和家庭都很有希望，参与者的满意度很高，父亲抑郁的情况也有所改善， 养育孩子，以及孩子的MH。这支持了在此建议的试点RCT的追求，使用一种有效性- 实施混合型设计，探索其初步成效及其实施。具体来说， 候选人将进行一项试验性随机对照试验，父亲被随机分为领班组或等待名单对照组，以 (目标1)探索父亲MH的变化；(目标2)探索父亲MH、父亲养育方式和 儿童MH(或无反应)；和(目标3)探讨实施任务转移的可行性和可接受性 在资源匮乏的环境下为父亲提供卫生保健服务。结果将为R01提案的制定提供信息 一项评估父亲和儿童MH临床结局和实施策略影响的混合试验。 拟议奖励中的培训、研究和合作伙伴关系将共同支持可扩展MH的测试 同伴父亲辅导员提供的治疗具有吸引男性和改善父亲和孩子的潜力 卫生部在低资源环境下，为NIMH最大化研究对公共健康的影响的目标做出了贡献。

PROJECT SUMMARY Globally, depression is the leading cause of disability world worldwide, yet over 75% of people in low and middle-income countries (LMIC) do not receive treatment. This gap is especially large for men. Treating men is essential to reducing the global burden of depression given its impact on families and children with men’s mental health (MH) predicting poor parenting and child MH. Although treating parent depression has been shown to improve parental MH, parenting, and child MH; men and fathers have been missing MH care and clinical trials. MH care relevant to fathers that address common barriers to MH, such as masculine norms and economic factors, are needed. The goal of the K23 is to expand the candidate’s skillset and prepare her to conduct independent research on scalable interventions for adult MH to improve child MH in low-resource settings. Through a combination of coursework and seminars, scientific conferences, collaborative publications, and mentorship from leading experts, the candidate will develop competency in 1) execution of randomized control trials using implementation science designs; 2) exploration of mechanism of change on MH using mixed methods; 3) understanding social determinant of health (SDH) on implementation. The candidate will apply knowledge and skills gained through training to conduct a pilot randomized control trial (RCT) using an effectiveness-implementation design in Kenya. The candidate will leverage existing partnerships with AMPATH and Moi Teaching and Referral Hospital (MTRH) in Kenya. She will also build on collaborative preliminary work with AMPATH/MTRH that showed promising proof-of-concept for ‘Learn, Act, Engage, Dedicate’ (LEAD), a 5-session task-shifted behavioral activation intervention with motivational interviewing and masculinity discussion strategies for fathers in Kenya. Proof-of-concept findings with nine fathers and families were promising with high participant satisfaction and improvements in father depression, parenting, and child MH. This supports pursuit of a pilot RCT, proposed here, using an effectiveness- implementation Hybrid Type I design to explore preliminary effectiveness and its implementation. Specifically, the candidate will conduct a pilot RCT with fathers randomized to either LEAD or a waitlist control group to (Aim1) explore change in fathers’ MH; (Aim 2) explore drivers of change in father MH, father parenting, and child MH (or non-response); and (Aim 3) explore the feasibility and acceptability of implementing a task-shifted MH treatment for fathers in a low-resource setting. Results will inform the development of an R01 proposal for a Hybrid trial to assess clinical outcomes of father and child MH and the impact of implementation strategies. Together, the training, research, and partnerships in the proposed award will support testing of a scalable MH treatment delivered by peer-father counselors with potential for engaging men and improving father and child MH in a low-resource setting, contributing to the NIMH’s goal of maximizing public health impact of research.