Shamiri Institute, Nairobi, Kenya.
Shamiri Institute, Allston, MA, USA.
Trials. 2023 Aug 13;24(1):526. doi: 10.1186/s13063-023-07539-y.
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.
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.
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.
Pan African Clinical Trials Registry (PACTR) (ID: PACTR202305589854478, Approved: 02/05/2023).
由于专业提供者短缺和社会污名化，肯尼亚很难为所有有需要的青年提供关爱。此前，Anansi 模式的试验表明，通过分层护理模式（包括非专业提供者、监督者和临床专家）提供低接触式心理健康干预措施，可以有效减少肯尼亚在校青少年的抑郁和焦虑症状。在这项试验中，我们旨在通过比较集中实施（即由设计 Anansi 模式的组织实施）与通过实施伙伴实施，评估两种不同的扩展策略。
在这项三臂试验中，将随机分配 1600 名 13 至 20 岁的青少年接受 Shamiri 干预，分为 Shamiri 研究所组或实施伙伴组，或置于常规治疗（TAU）对照组。实施伙伴将接受培训并提供协议，以确保两个实施者遵循相同的程序。实施活动将同时为两个实施者进行。Shamiri 干预将由经过培训的非专业人员在肯尼亚马查科斯和马库埃尼县的中学以小组形式（每组 10-15 名青少年）进行，每周进行 4 次。TAU 组将接受各自学校提供的常规护理。将在基线、中点（2 周）、终点（4 周）和 1 个月随访时评估结果。分析将基于意向治疗方法进行。将使用混合效应模型评估主要结局（焦虑和抑郁症状、心理健康、感知社会支持和学业成绩）和干预组和对照组的次要结局随时间的轨迹。将计算中点、终点和随访时干预组和对照组的平均差异的效应大小。
这项试验将深入了解不同策略扩展学校心理健康护理模式的相对效果。研究结果还将指出该模型提高效率的领域，以增强其可复制性，以便其他实施者复制。
泛非临床研究注册处（PACTR）（ID：PACTR202305589854478，批准日期：2023 年 5 月 2 日）。
