Liverpool Shaun, Edbrooke-Childs Julian
Evidence-Based Practice Unit, Anna Freud National Centre for Children and Families, University College London, London, United Kingdom.
Faculty of Health, Social Care & Medicine, Edge Hill University, Ormskirk, United Kingdom.
JMIR Form Res. 2021 Mar 2;5(3):e25235. doi: 10.2196/25235.
Interventions to involve parents in decisions regarding children's and young people's mental health are associated with positive outcomes. However, appropriately planning effectiveness studies is critical to ensure that meaningful evidence is collected. It is important to conduct pilot studies to evaluate the feasibility and acceptability of the intervention itself and the feasibility of the protocol to test effectiveness.
This paper reports the findings from a feasibility and acceptability study of Power Up for Parents, an intervention to promote shared decision-making (SDM) and support parents and caregivers making decisions regarding children's and young people's mental health.
A mixed method study design was adopted. In stage 1, health care professionals and parents provided feedback on acceptability, usefulness, and suggestions for further development. Stage 2 was a multicenter, 3-arm, individual, and cluster randomized controlled pilot feasibility trial with parents accessing services related to children's and young people's mental health. Outcome measures collected data on demographics, participation rates, SDM, satisfaction, and parents' anxiety. Qualitative data were analyzed using thematic analysis. Google Analytics estimates were used to report engagement with the prototype. Outcomes from both stages were tested against a published set of criteria for proceeding to a randomized controlled trial.
Despite evidence suggesting the acceptability of Power Up for Parents, the findings suggest that recruitment modifications are needed to enhance the feasibility of collecting follow-up data before scaling up to a fully powered randomized controlled trial. On the basis of the Go or No-Go criteria, only 50% (6/12) of the sites successfully recruited participants, and only 38% (16/42) of parents completed follow-up measures. Nonetheless, health care practitioners and parents generally accessed and used the intervention. Themes describing appearance and functionality, perceived need and general helpfulness, accessibility and appropriateness, and a wish list for improvement emerged, providing valuable information to inform future development and refinement of the intervention.
Owing to the high attrition observed in the trial, proceeding directly to a full randomized controlled trial may not be feasible with this recruitment strategy. Nonetheless, with some minor adjustments and upgrades to the intervention, this pilot study provides a platform for future evaluations of Power Up for Parents.
International Standard Randomized Controlled Trial Number (ISRCTN) 39238984; http://www.isrctn.com/ISRCTN39238984.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/14571.
让父母参与有关儿童和青少年心理健康决策的干预措施会带来积极结果。然而，合理规划有效性研究对于确保收集到有意义的证据至关重要。开展试点研究以评估干预措施本身的可行性和可接受性以及测试有效性方案的可行性很重要。
本文报告了一项针对“为父母助力”（Power Up for Parents）的可行性和可接受性研究的结果，这是一项旨在促进共同决策（SDM）并支持父母和照顾者就儿童和青少年心理健康做出决策的干预措施。
采用了混合方法研究设计。在第一阶段，医疗保健专业人员和父母就可接受性、有用性以及进一步发展的建议提供了反馈。第二阶段是一项多中心、三臂、个体和整群随机对照试点可行性试验，父母可获取与儿童和青少年心理健康相关的服务。结局指标收集了有关人口统计学、参与率、共同决策、满意度和父母焦虑的数据。定性数据采用主题分析法进行分析。使用谷歌分析估计值报告对原型的参与情况。根据已发表的一组用于进行随机对照试验的标准对两个阶段的结果进行了测试。
尽管有证据表明“为父母助力”具有可接受性，但研究结果表明，在扩大规模进行全面的随机对照试验之前，需要对招募方式进行调整，以提高收集随访数据的可行性。根据继续或终止标准，只有50%（6/12）的研究地点成功招募到了参与者，只有38%（16/42）的父母完成了随访措施。尽管如此，医疗保健从业者和父母普遍访问并使用了该干预措施。出现了描述外观和功能、感知需求和总体帮助性、可及性和适宜性以及改进愿望清单的主题，为该干预措施未来的开发和完善提供了有价值的信息。
由于在试验中观察到的高失访率，采用这种招募策略直接进行全面的随机对照试验可能不可行。尽管如此，对干预措施进行一些小的调整和升级后，这项试点研究为未来对“为父母助力”的评估提供了一个平台。
国际标准随机对照试验编号（ISRCTN）39238984；http://www.isrctn.com/ISRCTN39238984。
国际注册报告识别码（IRRID）：RR2-10.2196/14571。
