Testing pathways to scale: study protocol for a three-arm randomized controlled trial of a centralized and a decentralized ("Train the Trainers") dissemination of a mental health program for Kenyan adolescents.

Background: Providing care in Kenya to all youth in need is difficult because of a shortage of professional providers and societal stigma. Previous trials of the Anansi model, which involves delivering low-touch mental health interventions through a tiered caregiving model (including lay-providers, supervisors, and clinical experts), have shown its effectiveness for reducing depression and anxiety symptoms in school-going Kenyan adolescents. In this trial, we aim to assess two different scale-up strategies by comparing centralized implementation (i.e., by the organization that designed the Anansi model) against implementation through an implementing partner.

Methods: In this three-arm trial, 1600 adolescents aged 13 to 20 years will be randomized to receive the Shamiri intervention from either the Shamiri Institute or an implementation partner or to be placed in the treatment as usual (TAU) control group. The implementation partner will be trained and supplied with protocols to ensure that the same procedures are followed by both implementors. Implementation activities will run concurrently for both implementors. The Shamiri intervention will be delivered by trained lay providers to groups of 10-15 adolescents over four weekly sessions which will take place in secondary schools in Machakos and Makueni counties in Kenya. The TAU group will receive the usual care offered by their respective schools. Outcomes will be assessed at baseline, midpoint (2 weeks), endpoint (4 weeks), and 1 month follow-up. The analysis will be based on an intent-to-treat approach. Mixed effects models will be used to assess trajectories over time of the primary outcomes (anxiety and depressive symptoms, mental well-being, perceived social support, and academic performance) and secondary outcomes for the intervention groups and the control group. Effect sizes will be computed for the mean differences of the intervention and control arms at midpoint, endpoint, and follow-up.

Discussion: This trial will provide insight into the comparative effectiveness of different strategies for scaling a school-based mental health care model. Findings will also indicate areas for improved efficiency of the model to enhance its replicability by other implementors.

Trial Registration: Pan African Clinical Trials Registry (PACTR) (ID: PACTR202305589854478, Approved: 02/05/2023).

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