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Background: Children in low-and-middle-income countries (LMICs) are facing tremendous mental health challenges. Numerous evidence-based interventions (EBIs) have been adapted to LMICs and shown effectiveness in addressing the needs, but most EBIs have not been adopted widely using scalable and sustainable implementation models that leverage and strengthen existing structures. There is a need to apply implementation science methodology to study strategies to effectively scale-up EBIs and sustain the practices in LMICs. Through a cross-sector collaboration, we are carrying out a second-generation investigation of implementation and effectiveness of a school-based mental health EBI, ParentCorps Professional Development (PD), to scale-up and sustain the EBI in Uganda to promote early childhood students' mental health. Our previous studies in Uganda supported that culturally adapted PD resulted in short-term benefits for classrooms, children, and families. However, our previous implementation of PD was relied on mental health professionals (MHPs) to provide PD to teachers. Because of the shortage of MHPs in Uganda, a new scalable implementation model is needed to provide PD at scale., Objectives: This study tests a new scalable and sustainable PD implementation model and simultaneously studies the effectiveness. This paper describes use of collaboration, task-shifting, and Train-the-Trainer strategies for scaling-up PD, and protocol for studying the effectiveness-implementation of ParentCorps-PD for teachers in urban and rural Ugandan schools. We will examine whether the new scale-up implementation approach will yield anticipated impacts and investigate the underlying effectiveness-implementation mechanisms that contribute to success. In addition, considering the effects of PD on teachers and students will influence by teacher wellness. This study also examines the added value (i.e. impact and costs) of a brief wellness intervention for teachers and students., Methods: Using a hybrid-type II effectiveness-implementation cluster randomized controlled trial (cRCT), we will randomize 36 schools (18 urban and 18 rural) with 540 teachers and nearly 2000 families to one of three conditions: PD + Teacher-Wellness (PDT), PD alone (PD), and Control. Primary effectiveness outcomes are teachers' use of mental health promoting strategies, teacher stress management, and child mental health. The implementation fidelity/quality for the scale-up model will be monitored. Mixed methods will be employed to examine underlying mechanisms of implementation and impact as well as cost-effectiveness., Discussion: This research will generate important knowledge regarding the value of an EBI in urban and rural communities in a LMIC, and efforts toward supporting teachers to prevent and manage early signs of children's mental health issues as a potentially cost-effective strategy to promote child population mental health in low resource settings., Trial Registration: This trial was registered with ClinicalTrials.gov (registration number: NCT04383327; https://clinicaltrials.gov/ct2/show/NCT04383327 ) on May13, 2020., (© 2022. The Author(s).)

Background: ParentCorps is a family-centered enhancement to pre-kindergarten programming in elementary schools and early education centers. When implemented in high-poverty, urban elementary schools serving primarily Black and Latino children, it has been found to yield benefits in childhood across domains of academic achievement, behavior problems, and obesity. However, its long-term cost-effectiveness is unknown., Methods: We determined the cost-effectiveness of ParentCorps in high-poverty, urban schools using a Markov Model projecting the long-term impact of ParentCorps compared to standard pre-kindergarten programming. We measured costs and quality adjusted life years (QALYs) resulting from the development of three disease states (i.e., drug abuse, obesity, and diabetes); from the health sequelae of these disease states; from graduation from high school; from interaction with the judiciary system; and opportunity costs of unemployment with a lifetime time horizon. The model was built, and analyses were performed in 2015-2016., Results: ParentCorps was estimated to save $4387 per individual and increase each individual's quality adjusted life expectancy by 0.27 QALYs. These benefits were primarily due to the impact of ParentCorps on childhood obesity and the subsequent predicted prevention of diabetes, and ParentCorps' impact on childhood behavior problems and the subsequent predicted prevention of interaction with the judiciary system and unemployment. Results were robust on sensitivity analyses, with ParentCorps remaining cost saving and health generating under nearly all assumptions, except when schools had very small pre-kindergarten programs., Conclusions: Effective family-centered interventions early in life such as ParentCorps that impact academic, behavioral and health outcomes among children attending high-poverty, urban schools have the potential to result in longer-term health benefits and substantial cost savings.

Background: Children in Sub-Saharan Africa (SSA) are burdened by significant unmet mental health needs, but this region has limited access to mental health workers and resources to address these needs. Despite the successes of numerous school-based interventions for promoting child mental health, most evidence-based interventions are not available in SSA. This study will investigate the transportability of an evidence-based program from a developed country (United States) to a SSA country (Uganda). The approach includes task-shifting to early childhood teachers and consists of professional development (five days) to introduce strategies for effective behavior management and positive teacher-student interactions, and group-based consultation (14 sessions) to support adoption of effective practices and tailoring to meet the needs of individual students., Methods/design: The design of this study is guided by two implementation frameworks, the Consolidated Framework for Implementation Research and the Teacher Training Implementation Model, that consider multidimensional aspects of intervention fidelity and contextual predictors that may influence implementation and teacher outcomes. Using a cluster randomized design, 10 schools in Uganda will be randomized to either the intervention group (five schools) or the waitlist control group (five schools). A total of 80 to 100 early childhood teachers will be enrolled in the study. Teacher utilization of evidence-based strategies and practices will be assessed at baseline, immediate post-intervention (six months after baseline), and at seven months post-intervention (during a new academic year). Fidelity measures will be assessed throughout the program implementation period (during professional development and consultation sessions). Individual teacher and contextual factors will be assessed at baseline. Data will be collected from multiple sources. Linear mixed-effect modeling, adjusting for school nesting, will be applied to address study questions., Discussion: The study will produce important information regarding the value of an evidence-based early intervention, and a theory-guided implementation process and tools designed for use in implementing early childhood evidence-based programs in SSA countries or resource-constrained community settings., Trial Registration: This trial was registered with ClinicalTrials.gov (registration number: NCT097115) on 15 May 2013.