背景:结构化电子育儿支持(STEPS)是一种数字应用程序(应用程序),旨在帮助父母管理被转介给心理健康服务并正在等待评估或治疗的孩子的行为。目前,STEPS正在在线家长培训中进行评估,以进行注意力缺陷/多动障碍的初始管理随机对照试验。除了对STEPS的临床和成本效益进行检查,我们正在进行过程评估,以更好地了解可能影响研究结果的背景因素.该协议的目的是描述目标,进行前过程评估的目标和方法,以增加试验过程和结果的保真度和严谨性.我们的目标是调整STEPS,以优化其在未来应用中的优势。
方法:根据医学研究理事会关于评估复杂干预措施的指南,过程评估将采用混合方法设计,使用从临床医生和家长访谈中收集的定性数据以及分配到干预组的参与者的应用程序使用数据.
方法:将使用框架分析对试验问卷中包含的半结构化访谈和免费文本框回答的定性数据进行主题分析,以更好地了解父母如何使用STEPS,它是如何工作的,以及可能有助于或阻碍其在常规临床实践中有效实施的关键因素。
方法:本研究的伦理批准申请已提交给西北利物浦中央研究伦理委员会,并于2021年11月26日收到了对进一步信息的有利意见,参考号21/NW/0319。
结果:过程评估旨在探索数字应用程序如何支持父母管理孩子的行为。将探讨对政策和研究的影响,以及向更广泛的受众提供该应用程序的临床意义,以解决本文所强调的对父母缺乏支持的问题。我们计划在国际上发表调查结果,同行评审的期刊以及出席会议。
背景:该试验于2021年11月18日进行了前瞻性注册;ISRCTN816523503。https://www.isrctn.com/ISRCTN16523503.
BACKGROUND: Structured E-parenting Support (STEPS) is a digital application (app) designed to help parents manage behaviour of their children who are referred to mental health services and are waiting for an assessment or treatment. STEPS is currently being evaluated in the Online Parent Training for the Initial Management of Attention-Deficit/Hyperactivity Disorder randomised controlled
trial. Alongside the examination of STEPS\' clinical and cost-effectiveness, we are conducting a process evaluation to better understand the contextual factors that may influence
study outcomes. The purpose of this protocol is to describe the aims, objectives and methodology of the process evaluation prior to it taking place to add to the fidelity and rigour of the trial process and outcomes. Our goal is to adapt STEPS to optimise its benefits in future applications.
METHODS: In line with the Medical Research Council guidelines for evaluating complex interventions, the process evaluation will adopt a mixed method design using qualitative data collected from clinicians and parent interviews and app usage data from participants assigned to the intervention arm.
METHODS: Qualitative data from semistructured interviews and free text box responses included in
trial questionnaires will be analysed thematically using framework analysis to better understand how parents use STEPS, how it works and key factors that could aid or hinder its effective implementation in routine clinical practice.
METHODS: The application for ethical approval for the
study was submitted to the North West-Liverpool Central Research Ethics Committee and received a favourable opinion on further information on 26 November 2021, reference number 21/NW/0319.
RESULTS: The process evaluation aims to explore how a digital app might support parents in managing their child\'s behaviour. Implications for policy and research will be explored and the clinical implications of offering the app to a wider audience to address the lack of support to parents as highlighted in this paper. We plan to publish findings in international, peer-reviewed journals as well as present at conferences.
BACKGROUND: The
trial has been prospectively registered on 18 November 2021; ISRCTN816523503. https://www.isrctn.com/ISRCTN16523503.