Background:
This article describes the design of a large-scale study testing the Shamiri intervention. Whileearlier pilot studies showed promise, a rigorous trial with more participants was needed to confirm effectivenessand inform potential scaling.
Methods:
The study protocol outlined plans to recruit approximately 700 Kenyan secondary school studentswith depression or anxiety symptoms from 18 schools. Participants would be randomly assigned to receiveeither Shamiri or a study skills control intervention, both delivered by lay providers in 4 weekly group sessions.The protocol detailed all procedures for recruitment, intervention delivery, assessment, data analysis, and ethicaloversight.
Findings:
This is a protocol paper describing planned research rather than reporting results. The protocolestablished standardized procedures that would allow other researchers to evaluate and replicate the study. Italso pre-registered all analysis plans to ensure transparency and prevent selective reporting of results.
Implications:
Publishing detailed study protocols before data collection improves research quality andtransparency. This protocol provided a roadmap for testing whether lay-provider-delivered interventions couldwork at larger scale across multiple schools. The pre-registered approach strengthens confidence in the eventualfindings by demonstrating that results weren't selectively reported or analyses changed after seeing the data.
