London School of Hygiene & Tropical Medicine, London, UK
London School of Hygiene & Tropical Medicine, London, UK.
BMJ Open. 2024 Feb 12;14(2):e077788. doi: 10.1136/bmjopen-2023-077788.
No whole-school interventions which seek to reduce physical, sexual and emotional violence from peers, intimate partners and teachers have been trialled with adolescents. Here, we report a protocol for a pilot trial of the Good School Toolkit-Secondary Schools intervention, to be tested in Ugandan secondary schools. Our main objectives are to (1) refine the intervention, (2) to understand feasibility of delivery of the intervention and (3) to explore design parameters for a subsequent phase III trial.
We will conduct a pilot cluster randomised controlled trial, with two arms and parallel assignment. Eight schools will be randomly selected from a stratified list of all eligible schools in Kampala and Wakiso Districts. We will conduct a baseline survey and endline survey 18 months after the baseline, with 960 adolescents and 200 teachers. Qualitative data and mixed methods process data collection will be conducted throughout the intervention. Proportion of staff and students reporting acceptability, understanding and implementing with fidelity will be tabulated at endline for intervention schools. Proportions of schools consenting to participation, randomisation and proportions of schools and individual participants completing the baseline and endline surveys will be described in a Consolidated Standards of Reporting Trials diagram.
The ethical requirements of our project are complex. Full approvals have been received from the Mildmay Ethics Committee (0407-2019), the Uganda National Council for Science and Technology (SS 6020) and the London School of Hygiene & Tropical Medicine (16212). Results of this study will be published in peer-reviewed academic journals, and shared with public bodies, policy makers, study participants and the general public in Uganda.
PACTR202009826515511.
尚无针对青少年的、旨在减少来自同伴、亲密伴侣和教师的身体、性和情感暴力的全学校干预措施进行过试验。在这里,我们报告了一项针对乌干达中学的“好学校工具包-中学”干预措施的试点试验方案,该方案将对此进行测试。我们的主要目标是:(1) 完善干预措施;(2) 了解干预措施实施的可行性;(3) 探索下一阶段 III 期试验的设计参数。
我们将开展一项试点整群随机对照试验,采用双组平行分配。将从坎帕拉和瓦基索区所有符合条件的学校中,随机挑选 8 所学校。我们将在基线后 18 个月进行基线调查和终点调查,调查对象包括 960 名青少年和 200 名教师。在整个干预过程中,将进行定性数据和混合方法过程数据收集。在终点,将对干预学校的员工和学生报告的可接受性、理解和忠实执行的比例进行制表。将描述同意参与、随机分组以及完成基线和终点调查的学校和个人参与者的比例,以 CONSORT 图的形式呈现。
我们项目的伦理要求很复杂。已从米德尔马契伦理委员会(0407-2019)、乌干达国家科学技术委员会(SS 6020)和伦敦卫生与热带医学学院(16212)获得充分批准。该研究的结果将发表在同行评议的学术期刊上,并与公共机构、政策制定者、研究参与者和乌干达公众分享。
PACTR202009826515511。