背景:临床医生和研究人员应考虑干预措施的预期益处和潜在危害。育儿计划是针对儿童行为问题的广泛使用的基于证据的干预措施。然而,关于潜在负面影响的数据很少。本文的目的是增加育儿计划中不良事件(AE)评估的系统知识,并提供AE评估工具。
方法:作为RISE项目(预防东南欧儿童心理健康问题-适应,优化,测试和延长父母的终身健康),我们在北马其顿为2至9岁儿童行为问题的父母的三项序贯研究中开发并测试了AE评估程序,摩尔多瓦共和国,和罗马尼亚。本文报告了第一阶段评估工具的开发(N=140),阶段2(N=835),以及在第3阶段使用优化程序的最终经验(多中心随机对照试验,N=823),其中之前评估了不良事件,在干预分娩期间三次,并在1年随访。在每个时间点,参与者完成了12项AE检查表.如果报告了父母或孩子的中度至重度问题,进行了结构化的后续访谈。
结果:AE评估工具的反应率从6%(阶段1)增加到100%(阶段3),表明根据每个阶段的经验收集这些数据的情况有所改善。RCT(第3阶段)的结果显示,在最终优化的程序下,AE频率通常较低:在干预期间,没有记录严重不良事件(SAE);至少有一个AE报告了10%(在第一次会议之后),7%(第三届会议后),和4%(在上一届第五届会议之后)的参与者。已确定的(S)AE均与研究或干预无因果关系。需要考虑成本效益,以确定确保育儿计划参与者安全的最佳方法。
结论:所应用的主动AE评估程序提供了一种全面的AE评估工具,可供其他人使用-适应特定环境,如果需要。根据我们的经验,我们概述了未来研究的建议.
背景:ClinicalTrials.gov,注册号阶段1:NCT03552250;阶段2:NCT03865485;阶段3:NCT04721730。2021年1月13日注册
BACKGROUND: Clinicians and researchers should consider the expected benefits and potential harms of an intervention. Parenting programmes are a widely used evidence-based intervention for child behaviour problems. However, few data are available on potential negative effects. The aims of this paper were to increase systematic knowledge of adverse event (AE) assessment in parenting programmes and to provide an AE assessment tool.
METHODS: As part of the RISE project (prevention of child mental health problems in South-eastern Europe-adapt, optimise, test and extend parenting for lifelong health), we developed and tested an AE assessment procedure in three sequential studies for parents of children with child behaviour problems aged 2 to 9 years in North Macedonia, Republic of Moldova, and Romania. This paper reports on the development of the assessment tool in phase 1 (N = 140), phase 2 (N = 835), and the final experiences with using the optimised procedures in phase 3 (multisite randomised controlled trial, N = 823) in which AEs were assessed before, three times during intervention delivery, and at 1 year follow-up. At each time point, the participants completed a 12-item AE
checklist. If moderate-to-severe problems of parent or child were reported, a structured follow-up interview was conducted.
RESULTS: The response rate on the AE assessment tool increased from 6% (phase 1) to 100% (phase 3) indicating improvement in collecting these data based on the experiences of each phase. Results of the RCT (phase 3) showed generally low (S)AE frequencies with the finally optimised procedure: During the intervention, no serious adverse events (SAE) were registered; at least one AE was reported by 10% (after the first session), 7% (after the third session), and 4% (after the last fifth session) of participants. None of the identified (S)AEs was causally related to the study or intervention. Cost-benefit considerations are needed to determine the best way to ensure participant safety in parenting programmes.
CONCLUSIONS: The applied active AE assessment procedure provides a comprehensive AE assessment tool that can be used by others-with adaptations for the specific context, if needed. Based on our experiences, we outline recommendations for future studies.
BACKGROUND: ClinicalTrials.gov, registration number phase 1: NCT03552250; phase 2: NCT03865485, phase 3: NCT04721730 . Registered on 13 January 2021.