Implementation of a parent training intervention (SPARCK) to prevent childhood mental health problems: study protocol for a pragmatic implementation trial in Norwegian municipalities.

IF 2 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Trials Pub Date : 2024-12-21 DOI:10.1186/s13063-024-08704-7
Anette Arnesen Grønlie, Agathe Backer-Grøndahl, Ragnhild Bang Nes, Maria Begoña Gomez, Truls Tømmerås
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Abstract

Background: Effective evidence-based interventions (EBI) are necessary to prevent and avoid negative life trajectories for children with mental health problems. Even though many EBIs prove effective when tested, few are successfully implemented and used in real-world clinical practice. As a result, many children and families do not receive the best care in due time or at all. To reduce this research-practice gap, a combined RCT and implementation study of Supportive Parents-Coping Kids (SPARCK), a parent training intervention to prevent childhood mental health problems, will be performed. This study protocol concerns the implementation part of the larger effectiveness-implementation project.

Methods: The study is a correlational multi-site implementation study of SPARCK performed alongside a two-armed RCT, in 24 Norwegian municipalities. A quantitative three-wave longitudinal web-based data collection will be conducted among SPARCK practitioners and leaders in relevant services. We will investigate the relations between theory-driven and empirical implementation determinants and implementation outcomes, measured by fidelity, acceptability, appropriateness, and feasibility. In addition, we will examine how these implementation determinants and outcomes are associated with the clinical outcomes of SPARCK.

Discussion: The current study will investigate implementation determinants and their relation to indicators of implementation success, while simultaneously investigating effectiveness of an intervention optimized to the needs of both the target group and relevant stakeholders. Together, this may improve clinical effect, contextual fit, implementation success, and reduce the time lag between research findings and application in real-world settings.

Trial registration: ClinicalTrials.gov NCT05800522. Registered on 2023.03.23.

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实施预防儿童心理健康问题的父母培训干预措施:挪威各市务实实施试验的研究方案。
背景:有效的循证干预(EBI)对于预防和避免有心理健康问题的儿童的消极生活轨迹是必要的。尽管许多ebi在测试时证明是有效的,但很少有成功实施并在现实世界的临床实践中使用。结果,许多儿童和家庭没有在适当的时候或根本没有得到最好的照顾。为了缩小这一研究与实践的差距,我们将进行一项联合随机对照试验和实施研究,即支持父母-应对儿童(SPARCK),一种预防儿童心理健康问题的父母培训干预。本研究方案涉及更大的有效性实施项目的实施部分。方法:该研究是一项相关的多地点实施研究,在挪威24个城市进行了一项双臂随机对照试验。将在SPARCK从业者和相关服务的领导者之间进行定量的基于网络的三波纵向数据收集。我们将研究理论驱动和经验实施决定因素与实施结果之间的关系,通过保真度、可接受性、适当性和可行性来衡量。此外,我们将研究这些实施决定因素和结果如何与SPARCK的临床结果相关联。讨论:目前的研究将调查实施决定因素及其与实施成功指标的关系,同时调查针对目标群体和相关利益相关者的需求进行优化的干预措施的有效性。总之,这可以提高临床效果、环境契合度、实施成功率,并减少研究结果与实际应用之间的时间滞后。试验注册:ClinicalTrials.gov NCT05800522。2023.03.23注册
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来源期刊
Trials
Trials 医学-医学:研究与实验
CiteScore
3.80
自引率
4.00%
发文量
966
审稿时长
6 months
期刊介绍: Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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