Grønlie Anette Arnesen, Backer-Grøndahl Agathe, Nes Ragnhild Bang, Gomez Maria Begoña, Tømmerås Truls
Norwegian Center for Child Behavioral Development, Oslo, Norway.
Promenta Research Center, Department of Psychology, University of Oslo, Oslo, Norway.
Trials. 2024 Dec 21;25(1):846. doi: 10.1186/s13063-024-08704-7.
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.
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.
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.
ClinicalTrials.gov NCT05800522. Registered on 2023.03.23.
有效的循证干预措施(EBI)对于预防和避免有心理健康问题的儿童出现负面生活轨迹至关重要。尽管许多循证干预措施在测试时证明是有效的,但很少有能在现实世界的临床实践中成功实施和应用。因此,许多儿童和家庭无法及时获得最佳护理,甚至根本得不到。为了缩小这一研究与实践之间的差距,将开展一项支持性父母 - 应对儿童(SPARCK)的随机对照试验(RCT)与实施研究相结合的研究,SPARCK是一项预防儿童心理健康问题的家长培训干预措施。本研究方案涉及更大规模的有效性 - 实施项目的实施部分。
该研究是在挪威24个市镇开展的一项与双臂随机对照试验同时进行的SPARCK相关性多地点实施研究。将对相关服务中的SPARCK从业者和负责人进行基于网络的三波定量纵向数据收集。我们将调查理论驱动和实证实施决定因素与实施结果之间的关系,实施结果通过保真度、可接受性、适宜性和可行性来衡量。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。
当前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需求进行优化的干预措施的有效性。综合起来,这可能会提高临床效果、情境适应性、实施成功率,并减少研究结果与在现实环境中应用之间的时间间隔。
ClinicalTrials.gov NCT05800522。于2023年3月23日注册。