Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Universität Hamburg, Hamburg, Germany.
Department of Psychology, Clinical Psychology, and Psychotherapy, University of Bremen, Bremen, Germany.
Trials. 2024 Aug 17;25(1):547. doi: 10.1186/s13063-024-08357-6.
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.
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.
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.
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.
ClinicalTrials.gov, registration number phase 1: NCT03552250; phase 2: NCT03865485, phase 3: NCT04721730 . Registered on 13 January 2021.
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。育儿方案是一种广泛使用的循证干预措施，适用于儿童行为问题。然而，关于潜在的负面影响，数据很少。本文旨在增加对育儿方案中不良事件（AE）评估的系统认识，并提供一种 AE 评估工具。
作为 RISE 项目（东南欧预防儿童心理健康问题-适应、优化、测试和扩展终生健康育儿）的一部分，我们在马其顿北部、摩尔多瓦共和国和罗马尼亚对 2 至 9 岁有儿童行为问题的儿童的父母进行了三项连续研究，以开发和测试 AE 评估程序。本文报告了在第 1 阶段（N=140）、第 2 阶段（N=835）和第 3 阶段（多地点随机对照试验，N=823）的最终经验中使用优化程序的情况，在第 3 阶段中，在干预前、干预期间三次和 1 年随访时评估 AE。在每个时间点，参与者都完成了 12 项 AE 检查表。如果报告了父母或孩子的中度至重度问题，则进行了结构化随访访谈。
AE 评估工具的回复率从第 1 阶段的 6%（第 1 阶段）增加到第 3 阶段的 100%（第 3 阶段），这表明基于每个阶段的经验，收集这些数据的能力有所提高。RCT（第 3 阶段）的结果显示，一般来说，（S）AE 频率较低，采用最终优化程序：在干预期间，未记录到严重不良事件（SAE）；10%（第一次会议后）、7%（第三次会议后）和 4%（最后第五次会议后）的参与者报告了至少一个 AE。确定的（S）AE 均与研究或干预无关。需要进行成本效益分析，以确定确保育儿方案中参与者安全的最佳方式。
应用的主动 AE 评估程序提供了一种全面的 AE 评估工具，其他人可以使用-如果需要，可根据具体情况进行调整。根据我们的经验，我们为未来的研究提出了建议。
ClinicalTrials.gov，第 1 阶段：NCT03552250；第 2 阶段：NCT03865485，第 3 阶段：NCT04721730。于 2021 年 1 月 13 日注册。
