背景:在全球范围内,对儿童的暴力行为构成了巨大的健康和经济挑战,估计成本接近7万亿美元。这促使人们迫切需要有效的循证干预措施,以预防和减轻暴力侵害儿童行为。ParentApp是一个移动,开源应用程序,旨在提供远程版本的育儿终身健康(PLH)计划。ParentApp是第一个针对10-17岁青少年护理人员的数字育儿干预措施,在低收入和中等收入环境中进行测试。
方法:本研究是务实的,双臂,姆万扎的集群随机试验,坦桑尼亚的城市和城郊地区。评估设置为基线,干预后1个月,干预后12个月。我们随机化了80个集群,每个人都有大约30个照顾者-青少年二元,按城市或城市周边位置分层的比例为1:1。两个手臂都会收到预装有斯瓦希里语应用程序-ParentApp的入门级智能手机,以进行干预和WashApp控制。主要的分析方法将是广义线性混合效应模型,可以调整人的特征和多重归集。在三级模型中,测量波嵌套在一个人体内,嵌套在一个子区内。回归将约束群体在基线上相等,并包括用于分层的协变量,男性照顾者的百分比,和个人层面的特征。
结论:试验的准备工作于2022年12月开始,包括社区动员和致敏。滚动招聘,基线数据收集,实施工作在2023年4月至9月之间进行。2023年8月开始了为期一个月的测试后数据收集,到目前为止,护理人员和青少年的保留率分别达到了97%和94%。最终的测试后数据收集将于2024年9月开始,预计将持续到2025年4月。在中期分析之前,本SAP已提交给期刊,以在优势假设测试框架下保持科学完整性。
背景:该试验于2023年3月14日在开放科学框架上注册:https://doi.org/10.17605/OSF。IO/T9FXZ。试验方案发表在试验25,119(2024):Baerecke,L.,Ornellas,A.,Wamoyi,J.等人。坦桑尼亚预防青少年虐待的混合数字育儿计划:一项实用的集群随机对照试验的研究方案。试验25,119(2024)。https://doi.org/10.1186/s13063-023-07893-x.
BACKGROUND: Globally, violence against children poses substantial health and economic challenges, with estimated costs nearing USD 7 trillion. This prompts the urgent call for effective evidence-based interventions in preventing and mitigating violence against children. ParentApp is a mobile, open-source application designed to offer a remote version of the
Parenting for Lifelong Health (PLH) programme. ParentApp is the first digital
parenting intervention for caregivers of adolescents aged 10-17 years to be tested in low- and middle-income settings.
METHODS: This study is a pragmatic, two-arm, cluster-randomised trial in Mwanza, Tanzania\'s urban and peri-urban areas. Assessments are set for baseline, 1 month post-intervention, and 12 months post-intervention. We randomised 80 clusters, each with about 30 caregiver-adolescent dyads, with a 1:1 ratio stratified by urban or peri-urban location. Both arms receive an entry-level smartphone preloaded with Kiswahili apps-ParentApp for intervention and WashApp control. The primary method of analysis will be generalised linear mixed-effects models with adjustment for person-level characteristics and multiple imputation. In three-level models, measurement waves are nested within a person, nested within a sub-ward. Regressions will constrain groups to be equal at baseline and include covariates for stratification, percentage of male caregivers, and individual-level characteristics.
CONCLUSIONS: Preparations for the trial began in December 2022, including community mobilisation and sensitisation. Rolling recruitment, baseline data collection, and implementation onboarding took place between April and September 2023. One-month post-test data collection began in August 2023 and thus far achieved 97% and 94% retention rates for caregivers and adolescents respectively. Final post-test data collection will begin in September 2024, anticipated to run until April 2025. This SAP was submitted to the journal before the interim analysis to preserve scientific integrity under a superiority hypothesis testing framework.
BACKGROUND: The trial was registered on the Open Science Framework on 14 March 2023: https://doi.org/10.17605/OSF.IO/T9FXZ . The trial protocol was published in Trials 25, 119 (2024): Baerecke, L., Ornellas, A., Wamoyi, J. et al. A hybrid digital
parenting programme to prevent abuse of adolescents in Tanzania: study protocol for a pragmatic cluster-randomised controlled trial. Trials 25, 119 (2024). https://doi.org/10.1186/s13063-023-07893-x .