title: Implementing an early childhood school-based mental health promotion intervention in low-resource Ugandan schools: study protocol for a cluster randomized controlled trial.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  This trial was registered with ClinicalTrials.gov (registration number: NCT097115) on 15 May 2013.
authors.affiliation: Department of Population Health, New York University Langone Medical Center, 227 East 30th Street, 1st Floor, New York, NY 10016, USA. Keng-Yen.Huang@nyumc.org.
authors.forename: Keng-Yen
authors.initials: KY
authors.lastname: Huang
authors.forename: Janet
authors.initials: J
authors.lastname: Nakigudde
authors.forename: Esther
authors.initials: E
authors.lastname: Calzada
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Boivin
authors.forename: Gbenga
authors.initials: G
authors.lastname: Ogedegbe
authors.forename: Laurie Miller
authors.initials: LM
authors.lastname: Brotman
mesh_terms: D000367:Age Factors; D002648:Child; D002652:Child Behavior; D002657:Child Development; D002662:Child Health Services / Q000191:economics / Q000458:organization & administration; D002675:Child, Preschool; D003156:Community Mental Health Services / Q000191:economics / Q000458:organization & administration; D003906:Developing Countries / Q000191:economics; D061345:Early Medical Intervention / Q000191:economics / Q000458:organization & administration; D005178:Faculty / Q000458:organization & administration; D005260:Female; D017048:Health Care Costs; D006293:Health Promotion / Q000191:economics / Q000458:organization & administration; D006295:Health Resources / Q000191:economics; D006801:Humans; D007318:Inservice Training; D007858:Learning; D016014:Linear Models; D008297:Male; D008603:Mental Health; D010290:Parents / Q000523:psychology; D012107:Research Design; D012572:School Health Services / Q000191:economics / Q000458:organization & administration; D013334:Students / Q000523:psychology*; D013997:Time Factors; D014454:Uganda