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

Autor: Grønlie AA; Norwegian Center for Child Behavioral Development, Oslo, Norway. anette.gronlie@nubu.no., Backer-Grøndahl A; Norwegian Center for Child Behavioral Development, Oslo, Norway., Nes RB; Promenta Research Center, Department of Psychology, University of Oslo, Oslo, Norway.; Norwegian Institute of Public Health, Oslo, Norway., Gomez MB; Norwegian Center for Child Behavioral Development, Oslo, Norway., Tømmerås T; Norwegian Center for Child Behavioral Development, Oslo, Norway.
Jazyk: angličtina
Zdroj: Trials [Trials] 2024 Dec 21; Vol. 25 (1), pp. 846. Date of Electronic Publication: 2024 Dec 21.
DOI: 10.1186/s13063-024-08704-7
Abstrakt: 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.
Competing Interests: Declarations. Ethics approval and consent to participate: The study’s research methodology, procedures for data collection, and informed consent documentation have undergone ethical review and received approval from the Regional Committee for Medical Research Ethics in Norway (REK) [60] (id number: 543436) and the Norwegian Agency for Shared Services in Education and Research (SIKT) [61]. Any modifications to the study protocol will be duly reported and subject to review and approval by the REK committee. Families, practitioners, and leaders sign written consents upon project entry. SPARCK practitioners sign after training, leaders after they have been informed of the study. Consents offer tailored information to participant groups, detailed project involvement, data collection, and pros and cons. Basic information include research rationale, data handling, protection measures, data access rights, and withdrawal options. Eligible parents to the RCT receive written information to discuss with their children, designed for child comprehension. It explains project participation and outcomes if the family agrees or declines. For detailed information regarding the RCT, see Tømmerås et al. [21]. Consent for publication: Not applicable. Competing interests: The authors declare that they have no financial interests. All authors, except RBN, have taken part in the development and/or optimization of SPARCK. If successful, SPARCK will be integrated in the non-commercial intervention portfolio at NUBU and offered free-of-charge to Norwegian public services.
(© 2024. The Author(s).)
Databáze: MEDLINE
Externí odkaz: