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

Implementation of a parent training intervention (SPARCK) to prevent childhood mental health problems: study protocol for a pragmatic implementation trial in Norwegian municipalities | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Implementation of a parent training intervention (SPARCK) to prevent childhood mental health problems: study protocol for a pragmatic implementation trial in Norwegian municipalities Anette Arnesen Grønlie, Agathe Backer-Grøndahl, Ragnhild Bang Nes, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3964706/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 21 Dec, 2024 Read the published version in Trials → Version 1 posted 5 You are reading this latest preprint version 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 ID: NTCT05800522 Implementation implementation determinants implementation outcomes co-creation intervention child mental health problems implementation strategies protocol Contribution to the literature By conducting an implementation study alongside an effectiveness trial, this project may contribute with knowledge on how to accelerate implementation of EBIs into practice and disentangle the relations between implementation outcomes and clinical outcomes. This study will add to the implementation science by generating much-needed knowledge about the impact of implementation determinants on specific implementation outcomes (fidelity, acceptability, appropriateness, and feasibility). The current study capitalizes on a series of implementation strategies used in a previous development and optimization phase. As such, the study will contribute to the field of implementation strategies by documenting activities needed to promote implementation outcomes. Background During the latest half-century, numerous interventions aimed at reducing internalizing and externalizing mental health problems in children have been developed and tested empirically ( 1 ). Undoubtedly, early identification and effective evidence-based interventions (EBIs) to prevent and reduce these problems are important ( 1 – 4 ). Although several EBIs have proven effective in clinical research, they are rarely implemented and used in routine practice. A major challenge is that attempts to implement EBIs into routine practice often fail ( 5 ) or take too long. In fact, the time lag between production of evidence to practical application still averages to 15 years and more ( 6 – 9 ). If an intervention is not implemented successfully, it will not be effective in the practice field regardless of its clinical effectiveness ( 5 ). As a result, individuals in need of intervention will not benefit from them ( 10 ). The lack of effective EBIs in routine practice is a challenge in Norway as well, where most children and families in need do not have access to them ( 11 – 13 ). This failure to implement clinically effective interventions in routine practice is referred to as the research-practice gap between scientific knowledge and its application in real-world settings. The ultimate goal of implementation science is to reduce this gap and ensure that the best interventions for a particular target group become available and standard care in all relevant settings ( 14 ). As such, to enhance the uptake, reach, and sustained use of EBIs aimed at preventing and reducing internalizing and externalizing mental health problems in children, greater attention should be devoted to research on the implementation of such EBIs. Traditionally, there has been a substantial focus in the implementation field on studying individual, process, and system level determinants in the sites where the EBIs are introduced and implemented ( 15 ). Studying such contextual implementation determinants is an integral part of identifying and accounting for implementation outcomes ( 16 , 17 ). However, it has recently been suggested that to fully understand and improve implementation and sustainment of EBIs, more focus should be directed towards studying intervention characteristics and their relation to implementation outcomes. Even more crucial is to ensure that the EBIs cater to the unique needs of both users and stakeholders ( 15 , 18 ). User-centered design (UCD) has recently emerged in the field of psychosocial intervention design, with an emphasis on end-user needs, prototyping and rapid iterations, redesign and simplification, as well as exploitation of natural constraints ( 15 ). As such, an important focus of the overall Supportive Parents – Coping Kids (SPARCK) project has been to apply a UCD approach from the development phase of the SPARCK intervention. More specifically, the current study builds upon an elaborate co-creation and optimization period of not only the intervention, but also key implementation strategies. Co-creation of SPARCK intervention What follows provides a brief overview of the co-creation phase and study of the SPARCK intervention ( 19 ). The intervention itself is a novel transdiagnostic parent training intervention aimed at preventing mental health problems in children ( 19 – 21 ). It is tailored to frontline level services in Norwegian municipalities. The target group consists of parents of children aged 4 to 12 with elevated, but sub-clinical levels of internalizing symptoms (i.e., anxiety, depression, and withdrawal) and/or externalizing symptoms (i.e., conduct problems, opposition, and cooperation challenges). The intervention consists of a maximum of 12 sessions delivered individually and contains well-established and effective elements which are tailored to help parents promote coping skills in their children ( 21 ). The development and optimization phase of SPARCK was inspired by IDEAS Impact Framework ( 22 , 23 ), multiphase optimization strategy (MOST) ( 24 ) as well as UCD ( 15 ). A prototype of SPARCK was developed and piloted in three families (2018–2019). From the start, the implementation strategy “co-creation” was used actively, to increase usability, contextual fit and implementability ( 18 , 19 , 25 , 26 ). In Norway, potential target families for SPARCK encounter the municipal services across various systems, such as school health, educational and psychological counselling services, and child welfare services. Thus, in addition to tailoring the intervention to each family and their challenges, it was also important to adapt and optimize the implementation to the different services delivering it. After the pilot test, seven municipalities were recruited, and 14 practitioners, two from each municipality, were trained in a modified version of SPARCK. The modifications were conducted based on feedback from the pilot families and the practitioners’ experience. This was the first wave in the optimization process, which continued with a study consisting of two iterative mixed-methods cycles (2020–2021), in which practitioners tested SPARCK with 14 families in both cycles. After each cycle, SPARCK was optimized based on feedback from families and practitioners ( 19 ). The clinical efficacy of the intervention in terms of reduction in child internalizing and externalizing symptoms, as well as increase in positive parent- child interaction, was tested using single case experimental designs (SCEDs) with quantitative assessments at multiple time points. In addition, qualitative semi-structured interviews with parents were conducted post intervention ( 19 , 20 ). Alongside the iterative SCEDs and parent interviews, we conducted an exploratory implementation study with semi-structured interviews with the practitioners and their leaders in order to do a contextual analysis of determinants to successful implementation of SPARCK ( 27 ). The aim was to gain insights from the relevant stakeholders on barriers and facilitators to implementation, to inform intervention optimization and aid choice and adaptation of implementation strategies to overcome identified barriers ( 28 ). Furthermore, contextual analyses can be used to understand and interpret subsequent effectiveness and implementation outcomes ( 29 ), and as such, the secondary aim was to use the contextual analysis as a segue to the current RCT ( 21 ) and implementation study. The Consolidated Framework for Implementation Research (CFIR) ( 30 , 31 ) was used to plan the study, construct the interview guides, identify, analyze, and report on implementation determinants. Based on these findings and a recently developed implementation measure ( 32 – 34 ), a quantitative measure on determinants to implementing change was customized to SPARCK and the study context, with the aim of using it in the current implementation study. Implementation outcomes, determinants, and strategies To be able to differentiate between intervention and implementation failure or success, it is imperative to assess implementation outcomes in and of itself, as well as clinical outcomes ( 5 , 35 ), in addition to disentangle the two. In the present study, four implementation outcomes will be studied, and according to Damschroder et al. ( 36 ), these can be regarded as anticipated implementation outcomes and predictors of actual implementation outcomes. One such outcome that will be studied is fidelity. Historically, fidelity has been measured and reported more often than other implementation outcomes, and typically describes the degree of adherence to an intervention protocol, dose, and quality of delivery ( 5 ). Other outcomes in the current study, which are important in the early stages of all implementation efforts, include acceptability, appropriateness, and feasibility. While acceptability is the perception that an intervention is agreeable, palatable, or satisfactory, appropriateness can be described as the perceived fit, relevance, or compatibility of an intervention for a given setting or to address a particular problem ( 5 ). Lastly, feasibility is the extent to which stakeholders believe a new intervention can be successfully used or carried out within a given setting ( 5 ). Whereas implementation outcomes evaluate the degree of implementation success, and serve as prerequisites of clinical outcomes, implementation determinants may be defined as barriers and facilitators that influence the implementation outcomes ( 17 ). To advance the field of implementation, a need for more clarity on the relations between determinants and specific implementation outcomes has been expressed ( 10 ). Several implementation determinants have proven to be important precursors for successful implementation ( 17 , 30 , 31 ), including organizational factors such as readiness ( 37 , 38 ). Organizational readiness refers to organizational members’ collective change commitment and change efficacy to implement a certain change and can be more or less present in an individual, group, unit, department or organization ( 38 ). According to Damschroder et al. ( 36 ), CFIR now views implementation readiness as a higher-order construct within the framework. Deciding on how to address and overcome identified contextual barriers is another fundamental challenge in implementation research. Implementation strategies are the “how to” part of implementation and can be defined as specific methods or techniques used to improve the adoption, implementation, and sustainment of an intervention in the practice field ( 39 , 40 ). The current study capitalizes on a series of implementation strategies utilized in the co-creation and optimization phase of the intervention. These strategies are based on data from the iterative cycles, semi-structured interviews and feedback from relevant stakeholders ( 19 , 27 ), as well as existing knowledge in the field ( 25 , 26 ). Ultimately, the current study will use a variety of discrete and multifaceted implementation strategies ( 25 , 26 , 39 ) (see Additional file 1), chosen not only for the purpose of the current study but also for future implementation and sustainment in the practice field ( 18 ). Implementation strategies entail extensive resources; however, these are often not reported prospectively, and are typically investigated as part of implementation studies after an intervention has demonstrated effectiveness. In addition to delaying the implementation into real-world settings, this is a missed opportunity for furthering the implementation science field ( 41 ) and a possible source for replicability problems for both research and practice ( 42 ). Methods Aim This study is part of a larger effectiveness-implementation trial of the parent training intervention SPARCK. In a randomized controlled trial ( RCT ), SPARCK’s clinical effectiveness in preventing and reducing negative outcomes and promoting positive outcomes in children and parents is investigated. A separate study protocol is written for the RCT ( 21 ). In order to grant appropriate attention and space to the implementation part of the project, a separate implementation study protocol was deemed warranted. In the current study, we aim to investigate the relations between implementation determinants ( 30 , 31 ) and successful implementation of SPARCK, measured by four key implementation outcomes, namely fidelity, acceptability, appropriateness, and feasibility ( 5 ). In addition, we examine how implementation determinants and implementation outcomes are associated with clinical outcomes of the intervention. Finally, implementation strategies used in the trial will be specified and reported ( 25 , 39 ). The combined RCT and implementation study will add to the intervention and implementation knowledge field by investigating the effectiveness of an intervention tailored to the needs of the client families, as well as to the needs and context of the service providers at multiple levels and multiple sites. Together, this may result in improved clinical effect, better contextual fit, greater implementation success, and reduction of the time lag between research findings and usage in the practice field ( 18 , 43 , 44 ). The overall aim of the SPARCK project, including effectiveness and implementation, is to innovate municipal level frontline services with a usable and effective parent training intervention for prevention and reduction of childhood mental health problems. We have five research hypotheses to guide the investigation of implementation of SPARCK; 1) higher practitioner fidelity to SPARCK is associated with better clinical outcomes; 2) participants’ positive ratings of facilitators and negative ratings on barriers are associated with better clinical outcomes; 3) participants’ positive ratings of facilitators and negative ratings on barriers are associated with better implementation outcomes, 4) better implementation outcomes are associated with better clinical outcomes, and 5) participants from municipalities that engaged in co-creation of SPARCK will report more positive on organizational readiness and more positive implementation outcomes. Study design and data collection This study is a correlational implementation study performed alongside a two-armed RCT ( 21 ). The combined study can be described as a hybrid effectiveness-implementation type 2 trial ( 43 , 44 ), although the implementation strategies are not tested per se. To test the five research hypotheses, we will include a quantitative longitudinal web-based data collection spanning three time points, among SPARCK practitioners and their leaders. The first time point (T1) is during the initiation of the intervention in 2023, shortly after training of practitioners and information dissemination to leaders. The second data collection (T2) is after approximately one year when the practitioners have completed two cases each, and the last data collection (T3) after approximately two years, when the practitioners have completed four cases each. In addition, for hypotheses one, two, and four concerning relations with clinical outcomes, we will also include parent reported data on child symptoms and parent- child interaction from the RCT at pre, post (treatment termination ), and follow-up (six months after post) ( 21 ). Setting, participants, and recruitment The study will be conducted in 24 municipalities, which vary in size, demography and urbanicity and together represent all five health regions in Norway. Efforts are made to recruit heterogeneous municipalities, to reflect conditions as they are in the real world. The municipalities are part of an implementation network hosted by Norwegian Center for Child Behavioral Development (NUBU; Norwegian acronym), and thus have some experience with implementation of EBIs ( 45 ). Of the 24 municipalities, seven participated in co-creation of SPARCK ( 19 ). Participants in the implementation study are SPARCK practitioners and municipal leaders. Currently, this includes 44 recruited practitioners, including 14 from the seven co-creation municipalities. In addition to training in SPARCK, all practitioners are trained in and actively practice Parent Management Training – Oregon model (PMTO) ( 45 , 46 ). Some are also trained in other EBIs. All practitioners are employed in municipal frontline mental health services, such as health care, school health services, and child welfare services. Participants also include the practitioners’ leaders, including their immediate manager, and superior leaders at mid and top managerial levels in the various services. Around 80 municipal leaders have so far been identified and recruited to the study. However, as staff turnovers are bound to happen, more will be recruited as needed. Written informed consent will be obtained from all participants before inclusion in the study. Implementation frameworks and theory The study will be guided by the determinant framework CFIR ( 30 , 31 ), which will be used to systematically specify and assess potential barriers and facilitators along its domains (innovation, outer setting, inner setting, individuals, and implementation process) with underlying constructs and to explain how these determinants influence the implementation outcomes. The implementation theory Organizational Readiness ( 38 ) will provide a theoretical underpinning for how readiness is related to implementation outcomes. Proctor et al. ( 5 ) provide a framework to evaluate the four key implementation outcomes. Lastly, the Implementation Research Logic Model (IRLM) ( 47 ) will be used as a tool for reporting and specifying how the various elements (i.e., determinants, strategies, mechanisms of action, implementation outcomes, and intervention outcomes) are believed to relate. Measures All measures in the current study are Norwegian versions, which have been adapted to the current context with permissions from the original authors and have undergone piloting with similar individuals to the study sample . Measures on clinical outcomes are described in detail in the RCT protocol ( 21 ), and include various standardized and widely used instruments to investigate parent reported change in child externalizing and internalizing symptoms. Background variables. Demographic and service-related variables will be obtained from all participants (i.e., age, gender, municipality, type of employment service, educational level, professional background, role, job experience, training in EBIs, counselling experience, familiarity with SPARCK etc.). Fidelity to SPARCK. To investigate hypothesis one, Fidelity Questionnaire (FidQ) will be used to measure practitioners’ fidelity to SPARCK. FidQ was developed during the development phases of SPARCK, detailing recipients, intervention strategies employed, pedagogical tools, client engagement, and parental assessments of goals in intervention. FidQ will be completed by SPARCK practitioners weekly after each session. Implementation outcomes. Hypotheses two, three and four will be tested using various measures of implementation determinants and outcomes. In addition to fidelity, the implementation outcomes that will be tested are acceptability, appropriateness, and feasibility ( 5 , 35 ). These will be measured using the 4-item scales Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) ( 48 ). AIM, IAM, and FIM are measured on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree). Hence, higher scores indicate greater acceptability, appropriateness, and feasibility respectively. Implementation determinants. The 10-item version of Organizational Readiness for Implementing Change (ORIC) will be used to determine a collective level of organizational readiness for change ( 37 ). The scale measures how well employees at an organization feel they can implement the change in processes required by a proposed intervention and the degree to which they are likely to initiate change, exert greater effort, exhibit greater persistence, and display more cooperative behavior. The measure consists of two subscales labelled Change Commitment (5 items) and Change Efficacy (5 items). Items are measured on a 5-point Likert scale from 1 (Disagree) to 5 (Agree). Sum score is calculated across all items. Lower scores represent less organizational readiness for implementing change; higher scores represent a more favorable organizational readiness for implementing change. To measure other implementation determinants, we will use Implementation Determinants Measure (IDM). It consists of 47 items assessing factors that may hinder or foster successful implementation of an intervention into a given context. The measure is based on a 40-item scale, which was partly founded on CFIR ( 30 ) and partly on qualitative interviews with people involved in implementing mental health promotion programs in schools and kindergartens in Norway ( 32 – 34 ). For the present study, IDM was adapted and customized to fit SPARCK and the municipal services in Norway, as well as the current study’s target problem areas. The measure includes seven items not included in the 40-item version. The adaptations and additional items cover findings gained from the semi-structured interviews with 14 SPARCK practitioners and 15 municipal leaders who used SPARCK in the two test cycles ( 19 , 27 ). Additionally, they cover items from pilot tests of the adapted version among relevant municipal practitioners and leaders. Importantly, we made an effort to reflect the updated CFIR 2.0 ( 31 ) and an abbreviated measure of the CFIR-based Barrier Buster Tool when modifying and adapting it. The latter, developed by the CFIR Research Team in Ann Arbor, Michigan (based on unpublished work), assesses the constructs most reported to be associated with implementation outcomes. The final 47-item measure covers the CFIR domains innovation (14 items), outer setting (4 items), inner setting (8 items), individuals (8 items), and implementation process (13 items). Together, these comprise several sub constructs (i.e., innovation relative advantage, innovation complexity, individuals’ attitudes, skills and motivation, external pressure, tension for change, implementation climate, available resources etc.). Items are measured on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). After reversing negatively phrased questions, a sum score will be calculated across all items. Lower scores indicate less positive environment for successful implementation; higher scores indicate more positive environment for successful implementation. In addition, one open ended question is included (“Can you think of other factors that may affect the effectiveness or implementation of the intervention (positively or negatively)?”). After the study period, the IDM will also be used to detect barriers within and across organizations and municipalities, to guide selection and/or tailoring of relevant implementation strategies if SPARCK is implemented and scaled up. Subsequently, data from the IDM will be used in a future study to identify and understand relations between implementation strategies and mechanisms of change ( 49 ). Implementation strategies. Implementation strategies used during the clinical testing of SPARCK will be specified and reported throughout the study period (see Additional file 1 for a list of initiated and planned implementation strategies), along with reporting of and justification for tailoring of strategies. Strategies will be named and defined to align with the Expert Recommendations for Implementing Change (ERIC) compilation ( 25 ) and Proctor et al.’s ( 39 ) recommendations for specifying and reporting implementation strategies. Choice and adaptation of implementation strategies are based on NUBU’s implementation infrastructure and experience with implementing other EBIs ( 45 ), relevant implementation theories, models, and frameworks ( 26 , 30 , 31 , 38 ), as well as data from the contextual analysis of barriers and facilitators to implementation in the development and optimization phase of the SPARCK project ( 27 ). After study completion - and if SPARCK will be implemented into regular practice, there will be a follow-up study in which stakeholders will be asked to aid in choice and tailoring of appropriate implementation strategies to address barriers and facilitators, as well as investigation of implementation mechanisms ( 49 ). Data analysis The setting of the current study is inherently multilevel and hierarchical in structure. Participants work in different service settings across municipalities, and the municipalities themselves differ greatly in terms of geography, size, and resources. As such, we assume the need to address the multilevel context and will use multilevel linear modelling to assess the effects of time and implementation determinants on clinical effectiveness and implementation outcomes ( 50 , 51 ). In addition, we will assess demographic factors, moderators, mediators, and associations relevant to the proposed hypotheses. The project builds on a co-creative optimization process, which substantially enhances the potential for positive effect and implementation. Thus, we will also investigate whether there are any effects between municipalities that were part of the co-creation process and those who were not. Discussion This protocol outlines the rationale and design of an implementation study of SPARCK into multiple sites in Norwegian municipalities. SPARCK is a carefully co-created and optimized parent training intervention for prevention of child mental health problems. In addition to evaluating the clinical effect of SPARCK in an RCT, we aim to investigate the importance of various implementation factors, as effectiveness and implementation research are stronger when conducted in tandem ( 14 ). A dual focus on effectiveness and implementation represents a potential to speed up the uptake of an intervention, more effective implementation strategies, and more useful information for both researchers and decision makers ( 43 , 44 ). How to improve effectiveness of interventions targeting child mental health problems, and how to optimize their implementation and sustained use constitute major challenges, both applied and scientific, within prevention and implementation research. If children and families do not have access to EBIs they could have profited from, the implications may be severe at both personal and societal levels and include prolonged suffering for the families. The presented study may generate much-needed knowledge on how implementation determinants impact clinical outcomes, as well as specific implementation outcomes. An additional aim of the study is to explore and report on implementation strategies that are needed to promote sustainable long-term outcomes of parent training interventions for prevention of child mental health problems in Norway and beyond. Scientifically, the effectiveness study in this project may contribute to narrowing the knowledge gap on the effect of parent training interventions for child internalizing and externalizing symptoms ( 21 ). The implementation study may contribute to the implementation science field with knowledge on how contextual barriers can affect both clinical effectiveness and specific implementation outcomes that are important in the initial phase of implementation. This knowledge is essential when choosing, tailoring, and deploying implementation strategies ( 6 , 25 , 26 ) to address barriers, and ultimately to promote success and sustainment when implementing EBIs beyond the scope of a research study and into the real world ( 18 ). 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) (52) (id number: 543436) and the Norwegian Agency for Shared Services in Education and Research (SIKT) (53). 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. Availability of data and materials A comprehensive plan outlining the procedures for the collection, handling, and storage of data has received approval from SIKT. To ensure the security and privacy of sensitive information, we use the University of Oslo's Services for Sensitive Data (TSD) (54) for all data storage and analysis. We use Nettskjema (55), developed and operated by the University Information Technology Center, a TSD-integrated survey solution for collecting sensitive data. All study information, including participant identification keys and raw data, will be securely stored at TSD. Access to this information will be restricted to authorized personnel. We will implement measures to protect data confidentiality and integrity, including encryption of all data transfers and regular backups to safeguard against data loss. In the event of any breaches or unauthorized access, we will follow established protocols for reporting and responding to such incidents. The datasets generated in the current project are not publicly available due to the General Data Protection Regulation (GDPR) and Norwegian regulations but can be made available upon request. Competing interests The authors declare that they have no financial interests. All authors, except Ragnhild Bang Nes, 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. Funding This project has two main sources of funding. We have received external funding from the Kavli Trust Program on Health Research (56) and internal funding from the project host organization NUBU. Prior to receiving external funding, a project protocol has been reviewed by the Kavli scientific review board. Authors' contributions Truls Tømmerås (TT) is PI of the SPARCK project, Agathe Backer-Grøndahl (ABG) is co-PI. Anette Arnesen Grønlie (AAG), ABG and TT developed the overarching scientific aims and designed the current study. TT and ABG secured funding. TT and ABG designed the RCT, while Maria Begoña Gomez (MBG) and AAG contributed to the design. MBG, TT, and ABG contributed to the design and refinement of the SPARCK intervention. MBG contributed to the recruitment of municipalities, training, and supervision of supervisors. AAG, TT, ABG and MBG contributed to choice and design of implementation strategies. AAG, TT and ABG designed the statistical analysis plan. AAG will lead and conduct the data collection of the study. AAG wrote the manuscript draft. Ragnhild Bang Nes (RBN) contributed with supervision. AAG, TT, ABG, MBG, and RBN reviewed, gave feed-back, and approved the final version of this manuscript. Acknowledgements The authors would like to thank all participants that have consented to take part in the study. In addition, we would like to thank the municipal leaders and practitioners in “the lab” that took part in the co-creation process leading up the current study. We would also like to thank our co-developers Anett Apeland, Hanne Laland, Sissel Torsvik, and Elisabeth Askeland, as well as Andreas Høstmælingen, Line Ragna Aakre Karlsson, Hildegunn Elstad Christiansen, and all supervisors and members of NIT. Reporting standards This protocol is reported according to the TIDieR checklist (57) (Additional file 2). The RCT protocol is reported according to appropriate reporting standards for RCTs required by the journal (SPIRIT) (21). Trial status This is protocol version 1.0. The first participant to the current study consented to participate on 9. February 2023. Recruitment will be completed by 31. August 2025. Any amendment to the protocol will be reported to the Regional Committee for Medical Research Ethics in Norway (REK). Abbreviations AIM Acceptability of Intervention Measure CFIR Consolidated Framework for Implementation Research EBIs Evidence–based interventions ERIC Expert Recommendations for Implementing Change compilation FidQ Fidelity Questionnaire FIM Feasibility of Intervention Measure GDPR General Data Protection Regulation IAM Intervention Appropriateness Measure IDEAS Innovate, Develop, Evaluate, Adapt, Scale Impact Framework IDM Implementation Determinant Measure IRLM Implementation Research Logic Model MOST Multiphase Optimization Strategy NUBU Norwegian Center for Child Behavioral Development ORIC Organizational Readiness for Implementing Change PI Principal investigator PMTO Parent Management Training–Oregon model REK Regional Committee for Medical Research Ethics in Norway RCT Randomized Controlled Trial SCED Single Case Experimental Designs SIKT Norwegian Agency for Shared Services in Education and Research SPARCK Supportive Parents–Coping Kids SPIRIT Standard Protocol Items: Recommendations for Interventional Trials T1 Time 1 T2 Time 2 T3 Time 3 TIDieR Template for Intervention Description and Replication checklist and guide statement TSD University of Oslo's Services for Sensitive Data UCD User–centered design References Weisz JR, Kuppens S, Ng MY, Eckshtain D, Ugueto AM, Vaughn-Coaxum R, et al. 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Beidas RS, Dorsey S, Lewis CC, Lyon AR, Powell BJ, Purtle J, et al. Promises and pitfalls in implementation science from the perspective of US-based researchers: learning from a pre-mortem. Implement Sci. 2022;17(1):55. Tømmerås T, Backer-Grøndahl A, Arnesen A, Apeland A, Laland H, Askeland E et al. Study Protocol for a Research and Development Project: Optimizing a Unified Parent Training Intervention to Prevent Child Mental Health Problems and Neglect. medRxiv. 2022. Backer-Grøndahl A, Arnesen A, Idsøe T, Grønlie AA, Tømmerås T. Forebyggende hjelpetiltak under korona våren 2020. Psykologi i kommunen. 2022;1. Tømmerås T, Backer-Grøndahl A, Høstmælingen AT, Laland H, Gomez MB, Apeland A et al. Study protocol for a Randomized Controlled Trial of Supportive Parents – Coping Kids (SPARCK) - a Transdiagnostic and Personalized Parent Training Intervention to Prevent Childhood Mental Health Problems, 12 February 2024, PREPRINT (Version 1) available at Research Square [ https://doi.org/10.21203/rs.3.rs-3916963/v1] . Shonkoff J, Richmond J, Levitt P, Bunge S, Cameron J, Duncan G, et al. From best practices to breakthrough impacts a science-based approach to building a more promising future for young children and families. Cambirdge, MA: Harvard University,. ; 2016. pp. 747–56. Center on the Developing Child. Schindler HS, Fisher PA, Shonkoff JP. From innovation to impact at scale: Lessons learned from a cluster of research–community partnerships. Child Dev. 2017;88(5):1435–46. Collins LM, Kugler KC. Optimization of behavioral, biobehavioral, and biomedical interventions2018. 978–3 p. Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, et al. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015;10(1):1–14. Waltz TJ, Powell BJ, Fernández ME, Abadie B, Damschroder LJ. Choosing implementation strategies to address contextual barriers: diversity in recommendations and future directions. Implement Sci. 2019;14(1):42. Grønlie AA, Tømmerås T, Nes RB. Barriers and facilitators to implementation of a parent training intervention in Norwegian municipalities: a contextual analysis [Manuscript in preparation]. 2024. Powell BJ, Beidas RS, Lewis CC, Aarons GA, McMillen JC, Proctor EK, et al. Methods to Improve the Selection and Tailoring of Implementation Strategies. J Behav Health Serv Res. 2017;44(2):177–94. Stange KC, Glasgow RE. Considering and reporting important contextual factors in research on the patient-centered medical home. PCMH Res Methods Ser. 2013. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009;4(1):50. Damschroder LJ, Reardon CM, Widerquist MAO, Lowery J. The updated Consolidated Framework for Implementation Research based on user feedback. Implement Sci. 2022;17(1):75. Nygaard E, Edvoll M, Tidemann I, Holme IT, Bergum-Hansen M, Bølstad E et al. Implementation of Tuning in to Kids in Norwegian kindergartens: an investigation of implementation mechanisms in a cluster randomized intervention [Manuscript in preparation] 2023. Bogen A. Implementering av Robuste barn og unge, Trygg oppvekst og Alle har en psykisk helse: En prosessevaluering av tre psykisk helsefremmende prosjekter 2020. Liu J. Utvikling og evaluering av et spørreskjema for evaluering ved implementering av psykiske helsefremmende tiltak i skoler 2021. Lengnick-Hall R, Gerke DR, Proctor EK, Bunger AC, Phillips RJ, Martin JK, et al. Six practical recommendations for improved implementation outcomes reporting. Implement Sci. 2022;17(1):16. Damschroder LJ, Reardon CM, Widerquist MAO, Lowery J. Conceptualizing outcomes for use with the Consolidated Framework for Implementation Research (CFIR): the CFIR Outcomes Addendum. Implement Sci. 2022;17(1):7. Shea CM, Jacobs SR, Esserman DA, Bruce K, Weiner BJ. Organizational readiness for implementing change: a psychometric assessment of a new measure. Implement Sci. 2014;9(1):1–15. Weiner BJ. A theory of organizational readiness for change. Implement Sci. 2009;4(1):67. Proctor EK, Powell BJ, McMillen JC. Implementation strategies: recommendations for specifying and reporting. Implement Sci. 2013;8(1):139. Powell BJ, Fernandez ME, Williams NJ, Aarons GA, Beidas RS, Lewis CC, et al. Enhancing the impact of implementation strategies in healthcare: a research agenda. Front public health. 2019;7:3. Wensing M, Wilson P. Making implementation science more efficient: capitalizing on opportunities beyond the field. Implement Sci. 2023;18(1):40. Moore SA, Arnold KT, Beidas RS, Mendelson T. Specifying and reporting implementation strategies used in a school-based prevention efficacy trial. Implement Res Pract. 2021;2:26334895211047841. Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation Hybrid Designs: Combining Elements of Clinical Effectiveness and Implementation Research to Enhance Public Health Impact. Med Care. 2012;50(3):217–26. Curran GM, Landes SJ, McBain SA, Pyne JM, Smith JD, Fernandez ME et al. Reflections on 10 years of effectiveness-implementation hybrid studies. Front Health Serv. 2022;2. Askeland E, Forgatch MS, Apeland A, Reer M, Grønlie AA. Scaling up an Empirically Supported Intervention with Long-Term Outcomes: the Nationwide Implementation of GenerationPMTO in Norway. Prev Sci. 2019;20(8):1189–99. Forgatch MS, Patterson GR. In: Weisz JR, Kazdin AE, editors. Parent Management Training—Oregon Model: An intervention for antisocial behavior in children and adolescents. Evidence-based psychotherapies for children and adolescents: Guilford Press; 2010. Smith JD, Li DH, Rafferty MR. The implementation research logic model: a method for planning, executing, reporting, and synthesizing implementation projects. Implement Sci. 2020;15:1–12. Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, et al. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017;12:1–12. Lewis CC, Klasnja P, Powell BJ, Lyon AR, Tuzzio L, Jones S et al. From Classification to Causality: Advancing Understanding of Mechanisms of Change in Implementation Science. Front Public Health. 2018;6. Lengnick-Hall R, Williams NJ, Ehrhart MG, Willging CE, Bunger AC, Beidas RS, et al. Eight characteristics of rigorous multilevel implementation research: a step-by-step guide. Implement Sci. 2023;18(1):52. McNeish DM, Stapleton LM. The effect of small sample size on two-level model estimates: A review and illustration. Educational Psychol Rev. 2016;28:295–314. Regional Committees for Medical and Health Research Ethics in. Norway (REK)5 January 2024. Available from: https://www.forskningsetikk.no/en/about-us/our-committees-and-commission/rek/ . Norwegian Agency for Shared Services in. Education and Research (SIKT)5 January 2024. Available from: https://sikt.no/en/home . Services for Sensitive Data (TSD)5 January. 2024. Available from: https://www.uio.no/english/services/it/research/sensitive-data/index.html . Nettskjema5. January 2024. Available from: https://nettskjema.no/?lang=en . Kavli Trust Program on Health Research5 January. 2024. Available from: https://kavlifondet.no/en/ . Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ: Br Med J. 2014;348:g1687. Supplementary Files Additionalfile1listofimplementationstrategiesSPARCK.docx List of planned and initiated implementation strategies (Additional file 1) Additionalfile2TIDieRchecklistSPARCK.docx TIDieR checklist (Additional file 2) Cite Share Download PDF Status: Published Journal Publication published 21 Dec, 2024 Read the published version in Trials → Version 1 posted Editorial decision: Major revision 11 Oct, 2024 Reviewers agreed at journal 29 Aug, 2024 Reviewers invited by journal 31 May, 2024 Editor assigned by journal 03 Apr, 2024 First submitted to journal 04 Mar, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3964706","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":309129406,"identity":"32089d80-4f70-467c-8292-0732a31db0cc","order_by":0,"name":"Anette Arnesen Grønlie","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA50lEQVRIie3QsQrCMBCA4ZMOLhXXTPoK6V7qqyQUnIoKLh06BIS6qLOiD6GT6xWhLkHXQDsofYG6OYmCCi62ugnmnxK4j5AD0Ol+vAoysAHIB5MCH6cbaX9LADblpD4fbLPcB2c9HCMe/H2HJiNq9Pz3hKQxFyjBXcgdQyaTPk0lNaay4BnlWSIKwSXEo8jDhC+VR41a+F40VfckosuTXHblhCqvIiIBzp0ILCeWaltTGRNGTEmRxS6fpXFvYxb8paHcQ+4HdotUR9bxHDh8kgxWmVmwsUeEi9crloJbrU+GdDqd7k+7AoXGXFDo/s7UAAAAAElFTkSuQmCC","orcid":"https://orcid.org/0009-0005-6488-4129","institution":"Norwegian Center for Child Behavioral Development: Nasjonalt utviklingssenter for barn og unge AS","correspondingAuthor":true,"prefix":"","firstName":"Anette","middleName":"Arnesen","lastName":"Grønlie","suffix":""},{"id":309129407,"identity":"036371b4-b215-4dd6-a736-8ada9ad14429","order_by":1,"name":"Agathe Backer-Grøndahl","email":"","orcid":"","institution":"Norwegian Center for Child Behavioral Development: Nasjonalt utviklingssenter for barn og unge AS","correspondingAuthor":false,"prefix":"","firstName":"Agathe","middleName":"","lastName":"Backer-Grøndahl","suffix":""},{"id":309129408,"identity":"fcb5d509-4303-4682-88cf-dd054669039b","order_by":2,"name":"Ragnhild Bang Nes","email":"","orcid":"","institution":"Norwegian Institute of Public Health: Folkehelseinstituttet","correspondingAuthor":false,"prefix":"","firstName":"Ragnhild","middleName":"Bang","lastName":"Nes","suffix":""},{"id":309129409,"identity":"c64bb21a-5d58-4fb3-84dc-0e11f6cd3fda","order_by":3,"name":"Maria Begoña Gomez","email":"","orcid":"","institution":"Norwegian Center for Child Behavioral Development: Nasjonalt utviklingssenter for barn og unge AS","correspondingAuthor":false,"prefix":"","firstName":"Maria","middleName":"Begoña","lastName":"Gomez","suffix":""},{"id":309129410,"identity":"2332a20d-0b3a-4ac0-aed4-48612eba7115","order_by":4,"name":"Truls Tømmerås","email":"","orcid":"","institution":"Norwegian Center for Child Behavioral Development: Nasjonalt utviklingssenter for barn og unge AS","correspondingAuthor":false,"prefix":"","firstName":"Truls","middleName":"","lastName":"Tømmerås","suffix":""}],"badges":[],"createdAt":"2024-02-17 17:39:09","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3964706/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3964706/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13063-024-08704-7","type":"published","date":"2024-12-21T15:57:10+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":72201672,"identity":"1103b1e4-10aa-4a5b-b336-20a6e1555fae","added_by":"auto","created_at":"2024-12-23 16:09:35","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":764692,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3964706/v1/55401ebe-c1f9-427d-8944-6fe369ddbe0e.pdf"},{"id":57869991,"identity":"43c6ac49-be89-476e-bf0b-62f549f24eed","added_by":"auto","created_at":"2024-06-06 17:09:01","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":114212,"visible":true,"origin":"","legend":"\u003cp\u003eList of planned and initiated implementation strategies (Additional file 1)\u003c/p\u003e","description":"","filename":"Additionalfile1listofimplementationstrategiesSPARCK.docx","url":"https://assets-eu.researchsquare.com/files/rs-3964706/v1/bd954462d312dd15cc38f9b9.docx"},{"id":57870200,"identity":"9d1bcb81-9a08-4f8b-ad76-fd4a0153b27b","added_by":"auto","created_at":"2024-06-06 17:17:01","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":43992,"visible":true,"origin":"","legend":"\u003cp\u003eTIDieR checklist (Additional file 2)\u003c/p\u003e","description":"","filename":"Additionalfile2TIDieRchecklistSPARCK.docx","url":"https://assets-eu.researchsquare.com/files/rs-3964706/v1/311b0bdd67ead05b0f38b6f5.docx"}],"financialInterests":"","formattedTitle":"Implementation of a parent training intervention (SPARCK) to prevent childhood mental health problems: study protocol for a pragmatic implementation trial in Norwegian municipalities","fulltext":[{"header":"Contribution to the literature","content":"\u003cp\u003e\u003c/p\u003e\u003cul\u003e \u003cli\u003e \u003cp\u003eBy conducting an implementation study alongside an effectiveness trial, this project may contribute with knowledge on how to accelerate implementation of EBIs into practice and disentangle the relations between implementation outcomes and clinical outcomes.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eThis study will add to the implementation science by generating much-needed knowledge about the impact of implementation determinants on specific implementation outcomes (fidelity, acceptability, appropriateness, and feasibility).\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eThe current study capitalizes on a series of implementation strategies used in a previous development and optimization phase. As such, the study will contribute to the field of implementation strategies by documenting activities needed to promote implementation outcomes.\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e"},{"header":"Background","content":"\u003cp\u003eDuring the latest half-century, numerous interventions aimed at reducing internalizing and externalizing \u003cem class=\"Highlight htf42ccfb9-5a20-4c00-a242-49e5af408730\" highlight=\"true\" htmatch=\"mental\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003emental\u003c/em\u003e health problems in \u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"child*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003echildren\u003c/em\u003e have been developed and tested empirically (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). Undoubtedly, early identification and effective evidence-based interventions (EBIs) to prevent and reduce these problems are important (\u003cspan additionalcitationids=\"CR2 CR3\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e–\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). Although several EBIs have proven effective in clinical research, they are rarely implemented and used in routine practice. A major challenge is that attempts to implement EBIs into routine practice often fail (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e) or take too long. In fact, the time lag between production of evidence to practical application still averages to 15 years and more (\u003cspan additionalcitationids=\"CR7 CR8\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e–\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). If an intervention is not implemented successfully, it will not be effective in the practice field regardless of its clinical effectiveness (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). As a result, individuals in need of intervention will not benefit from them (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). The lack of effective EBIs in routine practice is a challenge in Norway as well, where most \u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"child*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003echildren\u003c/em\u003e and families in need do not have access to them (\u003cspan additionalcitationids=\"CR12\" citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e–\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). This failure to implement clinically effective interventions in routine practice is referred to as the research-practice gap between scientific knowledge and its application in real-world settings. The ultimate goal of implementation science is to reduce this gap and ensure that the best interventions for a particular target group become available and standard care in all relevant settings (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eAs such, to enhance the uptake, reach, and sustained use of EBIs aimed at preventing and reducing internalizing and externalizing \u003cem class=\"Highlight htf42ccfb9-5a20-4c00-a242-49e5af408730\" highlight=\"true\" htmatch=\"mental\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003emental\u003c/em\u003e health problems in \u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"child*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003echildren,\u003c/em\u003e greater attention should be devoted to research on the implementation of such EBIs. Traditionally, there has been a substantial focus in the implementation field on studying individual, process, and system level determinants in the sites where the EBIs are introduced and implemented (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). Studying such contextual implementation determinants is an integral part of identifying and accounting for implementation outcomes (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). However, it has recently been suggested that to fully understand and improve implementation and sustainment of EBIs, more focus should be directed towards studying intervention characteristics and their relation to implementation outcomes. Even more crucial is to ensure that the EBIs cater to the unique needs of both users and stakeholders (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). User-centered design (UCD) has recently emerged in the field of psychosocial intervention design, with an emphasis on end-user needs, prototyping and rapid iterations, redesign and simplification, as well as exploitation of natural constraints (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). As such, an important focus of the overall Supportive Parents – Coping Kids (SPARCK) project has been to apply a UCD approach from the development phase of the SPARCK intervention. More specifically, the current study builds upon an elaborate co-creation and optimization period of not only the intervention, but also key implementation strategies.\u003c/p\u003e\u003cp\u003e\u003cb\u003eCo-creation of SPARCK intervention\u003c/b\u003e\u003c/p\u003e\u003cp\u003eWhat follows provides a brief overview of the co-creation phase and study of the SPARCK intervention (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). The intervention itself is a novel transdiagnostic parent training intervention aimed at preventing \u003cem class=\"Highlight htf42ccfb9-5a20-4c00-a242-49e5af408730\" highlight=\"true\" htmatch=\"mental\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003emental\u003c/em\u003e health problems in \u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"child*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003echildren\u003c/em\u003e (\u003cspan additionalcitationids=\"CR20\" citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e–\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). It is tailored to frontline level services in Norwegian municipalities. The target group consists of parents of \u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"child*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003echildren\u003c/em\u003e aged 4 to 12 with elevated, but sub-clinical levels of internalizing symptoms (i.e., anxiety, depression, and withdrawal) and/or externalizing symptoms (i.e., conduct problems, opposition, and cooperation challenges). The intervention consists of a maximum of 12 sessions delivered individually and contains well-established and effective elements which are tailored to help parents promote coping skills in their \u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"child*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003echildren\u003c/em\u003e (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eThe development and optimization phase of SPARCK was inspired by IDEAS Impact Framework (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e), multiphase optimization strategy (MOST) (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e) as well as UCD (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). A prototype of SPARCK was developed and piloted in three families (2018–2019). From the start, the implementation strategy “co-creation” was used actively, to increase usability, contextual fit and implementability (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e). In Norway, potential target families for SPARCK encounter the municipal services across various systems, such as school health, educational and psychological counselling services, and \u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"child*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003echild\u003c/em\u003e welfare services. Thus, in addition to tailoring the intervention to each family and their challenges, it was also important to adapt and optimize the implementation to the different services delivering it.\u003c/p\u003e\u003cp\u003eAfter the pilot test, seven municipalities were recruited, and 14 practitioners, two from each municipality, were trained in a modified version of SPARCK. The modifications were conducted based on feedback from the pilot families and the practitioners’ experience. This was the first wave in the optimization process, which continued with a study consisting of two iterative mixed-methods cycles (2020–2021), in which practitioners tested SPARCK with 14 families in both cycles. After each cycle, SPARCK was optimized based on feedback from families and practitioners (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). The clinical efficacy of the intervention in terms of reduction in \u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"child*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003echild\u003c/em\u003e internalizing and externalizing symptoms, as well as increase in positive parent-\u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"child*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003echild\u003c/em\u003e interaction, was tested using single \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"case*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003ecase\u003c/em\u003e experimental designs (SCEDs) with quantitative assessments at multiple time points. In addition, \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"qualitative\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003equalitative\u003c/em\u003e semi-structured interviews with parents were conducted post intervention (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eAlongside the iterative SCEDs and parent interviews, we conducted an exploratory implementation study with semi-structured interviews with the practitioners and their leaders in order to do a contextual analysis of determinants to successful implementation of SPARCK (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e). The aim was to gain insights from the relevant stakeholders on barriers and facilitators to implementation, to \u003cem class=\"Highlight ht71194251-f7a6-4c2d-a145-3d9f25b46662\" highlight=\"true\" htmatch=\"inform\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003einform\u003c/em\u003e intervention optimization and aid choice and adaptation of implementation strategies to overcome identified barriers (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e). Furthermore, contextual analyses can be used to understand and interpret subsequent effectiveness and implementation outcomes (\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e), and as such, the \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"secondary\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003esecondary\u003c/em\u003e aim was to use the contextual analysis as a segue to the current \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"rct\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003eRCT\u003c/em\u003e (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e) and implementation study. The Consolidated Framework for Implementation Research (CFIR) (\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e, \u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e) was used to plan the study, construct the interview guides, identify, analyze, and report on implementation determinants. Based on these findings and a recently developed implementation measure (\u003cspan additionalcitationids=\"CR33\" citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e–\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e), a quantitative measure on determinants to implementing change was customized to SPARCK and the study context, with the aim of using it in the current implementation study.\u003c/p\u003e\u003cp\u003e\u003cb\u003eImplementation outcomes, determinants, and strategies\u003c/b\u003e\u003c/p\u003e\u003cp\u003eTo be able to differentiate between intervention and implementation failure or success, it is imperative to assess implementation outcomes in and of itself, as well as clinical outcomes (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e), in addition to disentangle the two. In the present study, four implementation outcomes will be studied, and according to Damschroder et al. (\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e), these can be regarded as anticipated implementation outcomes and predictors of actual implementation outcomes. One such outcome that will be studied is fidelity. Historically, fidelity has been measured and reported more often than other implementation outcomes, and typically describes the degree of adherence to an intervention protocol, dose, and quality of delivery (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). Other outcomes in the current study, which are important in the early stages of all implementation efforts, include acceptability, appropriateness, and feasibility. While acceptability is the perception that an intervention is agreeable, palatable, or satisfactory, appropriateness can be described as the perceived fit, relevance, or compatibility of an intervention for a given setting or to address a particular problem (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). Lastly, feasibility is the extent to which stakeholders believe a new intervention can be successfully used or carried out within a given setting (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eWhereas implementation outcomes evaluate the degree of implementation success, and serve as prerequisites of clinical outcomes, implementation determinants may be defined as barriers and facilitators that influence the implementation outcomes (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). To advance the field of implementation, a need for more clarity on the relations between determinants and specific implementation outcomes has been expressed (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). Several implementation determinants have proven to be important precursors for successful implementation (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e, \u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e), including organizational factors such as readiness (\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e, \u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e). Organizational readiness refers to organizational members’ collective change commitment and change efficacy to implement a certain change and can be more or less present in an individual, group, unit, department or organization (\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e). According to Damschroder et al. (\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e), CFIR now views implementation readiness as a higher-order construct within the framework.\u003c/p\u003e\u003cp\u003eDeciding on how to address and overcome identified contextual barriers is another fundamental challenge in implementation research. Implementation strategies are the “how to” part of implementation and can be defined as specific methods or techniques used to improve the adoption, implementation, and sustainment of an intervention in the practice field (\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e, \u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e). The current study capitalizes on a series of implementation strategies utilized in the co-creation and optimization phase of the intervention. These strategies are based on data from the iterative cycles, semi-structured interviews and feedback from relevant stakeholders (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e), as well as existing knowledge in the field (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e). Ultimately, the current study will use a variety of discrete and multifaceted implementation strategies (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e, \u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e) (see Additional file 1), chosen not only for the purpose of the current study but also for future implementation and sustainment in the practice field (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). Implementation strategies entail extensive resources; however, these are often not reported \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"prospective*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003eprospectively,\u003c/em\u003e and are typically investigated as part of implementation studies after an intervention has demonstrated effectiveness. In addition to delaying the implementation into real-world settings, this is a missed opportunity for furthering the implementation science field (\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e) and a possible source for replicability problems for both research and practice (\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e).\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cb\u003eAim\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThis study is part of a larger effectiveness-implementation trial of the parent training intervention SPARCK. In a \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"randomized controlled trial\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003erandomized controlled trial\u003c/em\u003e (\u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"rct\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003eRCT\u003c/em\u003e), SPARCK’s clinical effectiveness in preventing and reducing negative outcomes and promoting positive outcomes in \u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"child*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003echildren\u003c/em\u003e and parents is investigated. A separate study protocol is written for the \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"rct\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003eRCT\u003c/em\u003e (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). In order to grant appropriate attention and space to the implementation part of the project, a separate implementation study protocol was deemed warranted. In the current study, we aim to investigate the relations between implementation determinants (\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e, \u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e) and successful implementation of SPARCK, measured by four key implementation outcomes, namely fidelity, acceptability, appropriateness, and feasibility (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). In addition, we examine how implementation determinants and implementation outcomes are associated with clinical outcomes of the intervention. Finally, implementation strategies used in the trial will be specified and reported (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e). The combined \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"rct\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003eRCT\u003c/em\u003e and implementation study will add to the intervention and implementation knowledge field by investigating the effectiveness of an intervention tailored to the needs of the client families, as well as to the needs and context of the service providers at multiple levels and multiple sites. Together, this may result in improved clinical effect, better contextual fit, greater implementation success, and reduction of the time lag between research findings and usage in the practice field (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e, \u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eThe overall aim of the SPARCK project, including effectiveness and implementation, is to innovate municipal level frontline services with a usable and effective parent training intervention for prevention and reduction of \u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"child*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003echildhood\u003c/em\u003e \u003cem class=\"Highlight htf42ccfb9-5a20-4c00-a242-49e5af408730\" highlight=\"true\" htmatch=\"mental\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003emental\u003c/em\u003e health problems. We have five research hypotheses to guide the investigation of implementation of SPARCK; 1) higher practitioner fidelity to SPARCK is associated with better clinical outcomes; 2) participants’ positive \u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"rat*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003eratings\u003c/em\u003e of facilitators and negative \u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"rat*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003eratings\u003c/em\u003e on barriers are associated with better clinical outcomes; 3) participants’ positive \u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"rat*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003eratings\u003c/em\u003e of facilitators and negative \u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"rat*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003eratings\u003c/em\u003e on barriers are associated with better implementation outcomes, 4) better implementation outcomes are associated with better clinical outcomes, and 5) participants from municipalities that engaged in co-creation of SPARCK will report more positive on organizational readiness and more positive implementation outcomes.\u003c/p\u003e\u003cp\u003e\u003cb\u003eStudy design and data collection\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThis study is a correlational implementation study performed alongside a two-armed \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"rct\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003eRCT\u003c/em\u003e (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). The combined study can be described as a hybrid effectiveness-implementation type 2 trial (\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e, \u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e), although the implementation strategies are not tested per se. To test the five research hypotheses, we will include a quantitative longitudinal web-based data collection spanning three time points, among SPARCK practitioners and their leaders. The first time point (T1) is during the initiation of the intervention in 2023, shortly after training of practitioners and information dissemination to leaders. The second data collection (T2) is after approximately one year when the practitioners have completed two \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"case*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003ecases\u003c/em\u003e each, and the last data collection (T3) after approximately two years, when the practitioners have completed four \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"case*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003ecases\u003c/em\u003e each. In addition, for hypotheses one, two, and four concerning relations with clinical outcomes, we will also include parent reported data on \u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"child*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003echild\u003c/em\u003e symptoms and parent-\u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"child*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003echild\u003c/em\u003e interaction from the \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"rct\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003eRCT\u003c/em\u003e at pre, post (treatment \u003cem class=\"Highlight htf42ccfb9-5a20-4c00-a242-49e5af408730\" highlight=\"true\" htmatch=\"termination\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003etermination\u003c/em\u003e), and follow-up (six months after post) (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cb\u003eSetting, participants, and recruitment\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThe study will be conducted in 24 municipalities, which vary in size, demography and urbanicity and together represent all five health regions in Norway. Efforts are made to recruit heterogeneous municipalities, to reflect conditions as they are in the real world. The municipalities are part of an implementation network hosted by Norwegian Center for \u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"child*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003eChild\u003c/em\u003e Behavioral Development (NUBU; Norwegian acronym), and thus have some experience with implementation of EBIs (\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e). Of the 24 municipalities, seven participated in co-creation of SPARCK (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eParticipants in the implementation study are SPARCK practitioners and municipal leaders. Currently, this includes 44 recruited practitioners, including 14 from the seven co-creation municipalities. In addition to training in SPARCK, all practitioners are trained in and actively practice Parent Management Training – Oregon \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"model*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003emodel\u003c/em\u003e (PMTO) (\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e, \u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e). Some are also trained in other EBIs. All practitioners are employed in municipal frontline \u003cem class=\"Highlight htf42ccfb9-5a20-4c00-a242-49e5af408730\" highlight=\"true\" htmatch=\"mental\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003emental\u003c/em\u003e health services, such as health care, school health services, and \u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"child*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003echild\u003c/em\u003e welfare services. Participants also include the practitioners’ leaders, including their immediate manager, and superior leaders at mid and top managerial levels in the various services. Around 80 municipal leaders have so far been identified and recruited to the study. However, as staff turnovers are bound to happen, more will be recruited as needed. \u003cem class=\"Highlight ht71194251-f7a6-4c2d-a145-3d9f25b46662\" highlight=\"true\" htmatch=\"written informed consent\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003eWritten informed consent\u003c/em\u003e will be \u003cem class=\"Highlight ht71194251-f7a6-4c2d-a145-3d9f25b46662\" highlight=\"true\" htmatch=\"obtained\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003eobtained\u003c/em\u003e from all participants before inclusion in the study.\u003c/p\u003e\u003cp\u003e\u003cb\u003eImplementation frameworks and theory\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThe study will be guided by the determinant framework CFIR (\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e, \u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e), which will be used to systematically specify and assess potential barriers and facilitators along its domains (innovation, outer setting, inner setting, individuals, and implementation process) with underlying constructs and to explain how these determinants influence the implementation outcomes. The implementation theory Organizational Readiness (\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e) will provide a theoretical underpinning for how readiness is related to implementation outcomes. Proctor et al. (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e) provide a framework to evaluate the four key implementation outcomes. Lastly, the Implementation Research Logic \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"model*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003eModel\u003c/em\u003e (IRLM) (\u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e) will be used as a tool for reporting and specifying how the various elements (i.e., determinants, strategies, mechanisms of action, implementation outcomes, and intervention outcomes) are believed to relate.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMeasures\u003c/b\u003e\u003c/p\u003e\u003cp\u003eAll measures in the current study are Norwegian versions, which have been adapted to the current context with permissions from the original authors and have undergone piloting with similar individuals to the study \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"sample\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003esample\u003c/em\u003e. Measures on clinical outcomes are described in detail in the \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"rct\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003eRCT\u003c/em\u003e protocol (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e), and include various standardized and widely used instruments to investigate parent reported change in \u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"child*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003echild\u003c/em\u003e externalizing and internalizing symptoms.\u003c/p\u003e\u003cp\u003e\u003cem\u003eBackground variables.\u003c/em\u003e Demographic and service-related variables will be \u003cem class=\"Highlight ht71194251-f7a6-4c2d-a145-3d9f25b46662\" highlight=\"true\" htmatch=\"obtained\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003eobtained\u003c/em\u003e from all participants (i.e., age, gender, municipality, type of employment service, educational level, professional background, role, job experience, training in EBIs, counselling experience, familiarity with SPARCK etc.).\u003c/p\u003e\u003cp\u003e\u003cem\u003eFidelity to SPARCK.\u003c/em\u003e To investigate hypothesis one, Fidelity Questionnaire (FidQ) will be used to measure practitioners’ fidelity to SPARCK. FidQ was developed during the development phases of SPARCK, detailing recipients, intervention strategies employed, pedagogical tools, client engagement, and parental assessments of goals in intervention. FidQ will be completed by SPARCK practitioners weekly after each session.\u003c/p\u003e\u003cp\u003e\u003cem\u003eImplementation outcomes.\u003c/em\u003e Hypotheses two, three and four will be tested using various measures of implementation determinants and outcomes. In addition to fidelity, the implementation outcomes that will be tested are acceptability, appropriateness, and feasibility (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e). These will be measured using the 4-item scales Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) (\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e). AIM, IAM, and FIM are measured on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree). Hence, higher scores indicate greater acceptability, appropriateness, and feasibility respectively.\u003c/p\u003e\u003cp\u003e\u003cem\u003eImplementation determinants.\u003c/em\u003e The 10-item version of Organizational Readiness for Implementing Change (ORIC) will be used to determine a collective level of organizational readiness for change (\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e). The scale measures how well employees at an organization feel they can implement the change in processes required by a proposed intervention and the degree to which they are likely to initiate change, exert greater effort, exhibit greater persistence, and display more cooperative behavior. The measure consists of two subscales labelled Change Commitment (5 items) and Change Efficacy (5 items). Items are measured on a 5-point Likert scale from 1 (Disagree) to 5 (Agree). Sum score is calculated across all items. Lower scores represent less organizational readiness for implementing change; higher scores represent a more favorable organizational readiness for implementing change.\u003c/p\u003e\u003cp\u003eTo measure other implementation determinants, we will use Implementation Determinants Measure (IDM). It consists of 47 items assessing factors that may hinder or foster successful implementation of an intervention into a given context. The measure is based on a 40-item scale, which was partly founded on CFIR (\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e) and partly on \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"qualitative\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003equalitative\u003c/em\u003e interviews with people involved in implementing \u003cem class=\"Highlight htf42ccfb9-5a20-4c00-a242-49e5af408730\" highlight=\"true\" htmatch=\"mental\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003emental\u003c/em\u003e health promotion programs in schools and kindergartens in Norway (\u003cspan additionalcitationids=\"CR33\" citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e–\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e). For the present study, IDM was adapted and customized to fit SPARCK and the municipal services in Norway, as well as the current study’s target problem areas. The measure includes seven items not included in the 40-item version. The adaptations and additional items cover findings gained from the semi-structured interviews with 14 SPARCK practitioners and 15 municipal leaders who used SPARCK in the two test cycles (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e). Additionally, they cover items from pilot tests of the adapted version among relevant municipal practitioners and leaders. Importantly, we made an effort to reflect the updated CFIR 2.0 (\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e) and an abbreviated measure of the CFIR-based Barrier Buster Tool when modifying and adapting it. The latter, developed by the CFIR Research Team in Ann Arbor, Michigan (based on unpublished work), assesses the constructs most reported to be associated with implementation outcomes. The final 47-item measure covers the CFIR domains innovation (14 items), outer setting (4 items), inner setting (8 items), individuals (8 items), and implementation process (13 items). Together, these comprise several sub constructs (i.e., innovation relative advantage, innovation complexity, individuals’ attitudes, skills and motivation, external pressure, tension for change, implementation climate, available resources etc.). Items are measured on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). After reversing negatively phrased questions, a sum score will be calculated across all items. Lower scores indicate less positive environment for successful implementation; higher scores indicate more positive environment for successful implementation. In addition, one open ended question is included (“Can you think of other factors that may affect the effectiveness or implementation of the intervention (positively or negatively)?”). After the study period, the IDM will also be used to detect barriers within and across organizations and municipalities, to guide selection and/or tailoring of relevant implementation strategies if SPARCK is implemented and scaled up. Subsequently, data from the IDM will be used in a future study to identify and understand relations between implementation strategies and mechanisms of change (\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cem\u003eImplementation strategies.\u003c/em\u003e Implementation strategies used during the clinical testing of SPARCK will be specified and reported throughout the study period (see Additional file 1 for a list of initiated and planned implementation strategies), along with reporting of and justification for tailoring of strategies. Strategies will be named and defined to align with the Expert Recommendations for Implementing Change (ERIC) compilation (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e) and Proctor et al.’s (\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e) recommendations for specifying and reporting implementation strategies. Choice and adaptation of implementation strategies are based on NUBU’s implementation infrastructure and experience with implementing other EBIs (\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e), relevant implementation theories, \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"model*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003emodels,\u003c/em\u003e and frameworks (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e, \u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e, \u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e, \u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e), as well as data from the contextual analysis of barriers and facilitators to implementation in the development and optimization phase of the SPARCK project (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e). After study completion - and if SPARCK will be implemented into regular practice, there will be a follow-up study in which stakeholders will be asked to aid in choice and tailoring of appropriate implementation strategies to address barriers and facilitators, as well as investigation of implementation mechanisms (\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cb\u003eData analysis\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThe setting of the current study is inherently multilevel and hierarchical in structure. Participants work in different service settings across municipalities, and the municipalities themselves differ greatly in terms of geography, size, and resources. As such, we assume the need to address the multilevel context and will use multilevel linear \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"model*\" htloopnumber=\"276433510\" style=\"font-style: inherit;\"\u003emodelling\u003c/em\u003e to assess the effects of time and implementation determinants on clinical effectiveness and implementation outcomes (\u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e, \u003cspan citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e). In addition, we will assess demographic factors, moderators, mediators, and associations relevant to the proposed hypotheses. The project builds on a co-creative optimization process, which substantially enhances the potential for positive effect and implementation. Thus, we will also investigate whether there are any effects between municipalities that were part of the co-creation process and those who were not.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis protocol outlines the rationale and design of an implementation study of SPARCK into multiple sites in Norwegian municipalities. SPARCK is a carefully co-created and optimized parent training intervention for prevention of child mental health problems. In addition to evaluating the clinical effect of SPARCK in an RCT, we aim to investigate the importance of various implementation factors, as effectiveness and implementation research are stronger when conducted in tandem (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). A dual focus on effectiveness and implementation represents a potential to speed up the uptake of an intervention, more effective implementation strategies, and more useful information for both researchers and decision makers (\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e, \u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eHow to improve effectiveness of interventions targeting child mental health problems, and how to optimize their implementation and sustained use constitute major challenges, both applied and scientific, within prevention and implementation research. If children and families do not have access to EBIs they could have profited from, the implications may be severe at both personal and societal levels and include prolonged suffering for the families. The presented study may generate much-needed knowledge on how implementation determinants impact clinical outcomes, as well as specific implementation outcomes. An additional aim of the study is to explore and report on implementation strategies that are needed to promote sustainable long-term outcomes of parent training interventions for prevention of child mental health problems in Norway and beyond.\u003c/p\u003e \u003cp\u003eScientifically, the effectiveness study in this project may contribute to narrowing the knowledge gap on the effect of parent training interventions for child internalizing and externalizing symptoms (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). The implementation study may contribute to the implementation science field with knowledge on how contextual barriers can affect both clinical effectiveness and specific implementation outcomes that are important in the initial phase of implementation. This knowledge is essential when choosing, tailoring, and deploying implementation strategies (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e) to address barriers, and ultimately to promote success and sustainment when implementing EBIs beyond the scope of a research study and into the real world (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e).\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch3\u003eEthics approval and consent to participate\u003c/h3\u003e\n\u003cp \u003eThe study\u0026apos;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) (52) (id number: 543436) and the Norwegian Agency for Shared Services in Education and Research (SIKT) (53). Any modifications to the study protocol will be duly reported and subject to review and approval by the REK committee.\u003c/p\u003e\n\u003cp \u003eFamilies, 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.\u0026nbsp;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 T\u0026oslash;mmer\u0026aring;s et al. (21).\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eConsent for publication\u003c/span\u003e\u003c/h3\u003e\n\u003cp\u003eNot applicable.\u003c/span\u003e\u003c/p\u003e\n\u003ch3 \u003eAvailability of data and materials\u003c/p\u003e\n\u003cp\u003eA comprehensive plan outlining the procedures for the collection, handling, and storage of data has received approval from SIKT. To ensure the security and privacy of sensitive information, we use the University of Oslo\u0026apos;s Services for Sensitive Data (TSD) (54) for all data storage and analysis. We use Nettskjema (55), developed and operated by the University Information Technology Center, a TSD-integrated survey solution for collecting sensitive data. All study information, including participant identification keys and raw data, will be securely stored at TSD. Access to this information will be restricted to authorized personnel. We will implement measures to protect data confidentiality and integrity, including encryption of all data transfers and regular backups to safeguard against data loss. In the event of any breaches or unauthorized access, we will follow established protocols for reporting and responding to such incidents.\u003c/p\u003e\n\u003cp\u003eThe datasets generated in the current project are not publicly available due to the General Data Protection Regulation (GDPR) and Norwegian regulations but can be made available upon request. \u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eCompeting interests\u003c/h3\u003e\n\u003cp\u003eThe authors declare that they have no financial interests. All authors, except Ragnhild Bang Nes, 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.\u003c/p\u003e\n\u003ch3\u003eFunding\u003c/h3\u003e\n\u003cp\u003eThis project has two main sources of funding. We have received external funding from the Kavli Trust Program on Health Research (56) and internal funding from the project host organization NUBU. Prior to receiving external funding, a project protocol has been reviewed by the Kavli scientific review board.\u003c/p\u003e\n\u003ch3\u003eAuthors\u0026apos; contributions\u003c/h3\u003e\n\u003cp\u003eTruls T\u0026oslash;mmer\u0026aring;s (TT) is PI of the SPARCK project, Agathe Backer-Gr\u0026oslash;ndahl (ABG) is co-PI. Anette Arnesen Gr\u0026oslash;nlie (AAG), ABG and TT developed the overarching scientific aims and designed the current study. TT and ABG secured funding. TT and ABG designed the RCT, while Maria Bego\u0026ntilde;a Gomez (MBG) and AAG contributed to the design. MBG, TT, and ABG contributed to the design and refinement of the SPARCK intervention. MBG contributed to the recruitment of municipalities, training, and supervision of supervisors. AAG, TT, ABG and MBG contributed to choice and design of implementation strategies. AAG, TT and ABG designed the statistical analysis plan. AAG will lead and conduct the data collection of the study. AAG wrote the manuscript draft. Ragnhild Bang Nes (RBN) contributed with supervision. AAG, TT, ABG, MBG, and RBN reviewed, gave feed-back, and approved the final version of this manuscript.\u003c/p\u003e\n\u003ch3\u003eAcknowledgements\u003c/h3\u003e\n\u003cp\u003eThe authors would like to thank all participants that have consented to take part in the study. In addition, we would like to thank the municipal leaders and practitioners in \u0026ldquo;the lab\u0026rdquo; that took part in the co-creation process leading up the current study. We would also like to thank our co-developers Anett Apeland, Hanne Laland, Sissel Torsvik, and Elisabeth Askeland, as well as Andreas H\u0026oslash;stm\u0026aelig;lingen, Line Ragna Aakre Karlsson, Hildegunn Elstad Christiansen, and all supervisors and members of NIT. \u0026nbsp; \u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eReporting standards\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eThis protocol is reported according to the TIDieR checklist (57) (Additional file 2). The RCT protocol is reported according to appropriate reporting standards for RCTs required by the journal (SPIRIT) (21).\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eTrial status\u003c/h3\u003e\n\u003cp\u003eThis is protocol version 1.0. The first participant to the current study consented to participate on 9. February 2023. Recruitment will be completed by 31. August 2025. Any amendment to the protocol will be reported to the Regional Committee for Medical Research Ethics in Norway (REK).\u0026nbsp;\u003c/span\u003e\u003cspan style=\"font-size:16px;line-height:200%;color:black;\"\u003e\u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/span\u003e\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eAIM\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eAcceptability of Intervention Measure\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCFIR\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eConsolidated Framework for Implementation Research\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eEBIs\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eEvidence\u0026ndash;based interventions\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eERIC\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eExpert Recommendations for Implementing Change compilation\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eFidQ\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eFidelity Questionnaire\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eFIM\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eFeasibility of Intervention Measure\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eGDPR\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eGeneral Data Protection Regulation\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eIAM\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eIntervention Appropriateness Measure\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eIDEAS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eInnovate, Develop, Evaluate, Adapt, Scale Impact Framework\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eIDM\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eImplementation Determinant Measure\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eIRLM\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eImplementation Research Logic Model\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eMOST\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eMultiphase Optimization Strategy\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNUBU\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNorwegian Center for Child Behavioral Development\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eORIC\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eOrganizational Readiness for Implementing Change\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003ePI\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ePrincipal investigator\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003ePMTO\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eParent Management Training\u0026ndash;Oregon model\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eREK\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eRegional Committee for Medical Research Ethics in Norway\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eRCT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eRandomized Controlled Trial\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSCED\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eSingle Case Experimental Designs\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSIKT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNorwegian Agency for Shared Services in Education and Research\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSPARCK\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eSupportive Parents\u0026ndash;Coping Kids\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSPIRIT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eStandard Protocol Items: Recommendations for Interventional Trials\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eT1\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eTime 1\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eT2\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eTime 2\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eT3\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eTime 3\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eTIDieR\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eTemplate for Intervention Description and Replication checklist and guide statement\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eTSD\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eUniversity of Oslo's Services for Sensitive Data\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eUCD\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eUser\u0026ndash;centered design\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eWeisz JR, Kuppens S, Ng MY, Eckshtain D, Ugueto AM, Vaughn-Coaxum R, et al. What five decades of research tells us about the effects of youth psychological therapy: A multilevel meta-analysis and implications for science and practice. Am Psychol. 2017;72(2):79.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eThapar A, Pine DS, Leckman JF, Scott S, Snowling MJ, Taylor EA. Rutter's child and adolescent psychiatry: Wiley; 2017.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCaspi A, Houts RM, Ambler A, Danese A, Elliott ML, Hariri A, et al. Longitudinal Assessment of Mental Health Disorders and Comorbidities Across 4 Decades Among Participants in the Dunedin Birth Cohort Study. JAMA Netw Open. 2020;3(4):e203221\u0026ndash;e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMarchette LK, Weisz JR. Practitioner review: Empirical evolution of youth psychotherapy toward transdiagnostic approaches. 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Implementering av Robuste barn og unge, Trygg oppvekst og Alle har en psykisk helse: En prosessevaluering av tre psykisk helsefremmende prosjekter 2020.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLiu J. Utvikling og evaluering av et sp\u0026oslash;rreskjema for evaluering ved implementering av psykiske helsefremmende tiltak i skoler 2021.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLengnick-Hall R, Gerke DR, Proctor EK, Bunger AC, Phillips RJ, Martin JK, et al. Six practical recommendations for improved implementation outcomes reporting. Implement Sci. 2022;17(1):16.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDamschroder LJ, Reardon CM, Widerquist MAO, Lowery J. Conceptualizing outcomes for use with the Consolidated Framework for Implementation Research (CFIR): the CFIR Outcomes Addendum. Implement Sci. 2022;17(1):7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eShea CM, Jacobs SR, Esserman DA, Bruce K, Weiner BJ. 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Implement Sci. 2017;12:1\u0026ndash;12.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLewis CC, Klasnja P, Powell BJ, Lyon AR, Tuzzio L, Jones S et al. From Classification to Causality: Advancing Understanding of Mechanisms of Change in Implementation Science. Front Public Health. 2018;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLengnick-Hall R, Williams NJ, Ehrhart MG, Willging CE, Bunger AC, Beidas RS, et al. Eight characteristics of rigorous multilevel implementation research: a step-by-step guide. Implement Sci. 2023;18(1):52.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMcNeish DM, Stapleton LM. The effect of small sample size on two-level model estimates: A review and illustration. Educational Psychol Rev. 2016;28:295\u0026ndash;314.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRegional Committees for Medical and Health Research Ethics in. Norway (REK)5 January 2024. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.forskningsetikk.no/en/about-us/our-committees-and-commission/rek/\u003c/span\u003e\u003cspan address=\"https://www.forskningsetikk.no/en/about-us/our-committees-and-commission/rek/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNorwegian Agency for Shared Services in. Education and Research (SIKT)5 January 2024. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://sikt.no/en/home\u003c/span\u003e\u003cspan address=\"https://sikt.no/en/home\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eServices for Sensitive Data (TSD)5 January. 2024. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.uio.no/english/services/it/research/sensitive-data/index.html\u003c/span\u003e\u003cspan address=\"https://www.uio.no/english/services/it/research/sensitive-data/index.html\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNettskjema5. January 2024. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://nettskjema.no/?lang=en\u003c/span\u003e\u003cspan address=\"https://nettskjema.no/?lang=en\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKavli Trust Program on Health Research5 January. 2024. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://kavlifondet.no/en/\u003c/span\u003e\u003cspan address=\"https://kavlifondet.no/en/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ: Br Med J. 2014;348:g1687.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Implementation, implementation determinants, implementation outcomes, co-creation, intervention, child mental health problems, implementation strategies, protocol","lastPublishedDoi":"10.21203/rs.3.rs-3964706/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3964706/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e \u0026nbsp;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.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: \u0026nbsp;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.\u003c/p\u003e\n\u003cp\u003eWe 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.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion:\u003c/strong\u003e 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.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration\u003c/strong\u003e: ClinicalTrials.gov ID: NTCT05800522\u003c/p\u003e","manuscriptTitle":"Implementation of a parent training intervention (SPARCK) to prevent childhood mental health problems: study protocol for a pragmatic implementation trial in Norwegian municipalities","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-06-06 17:08:57","doi":"10.21203/rs.3.rs-3964706/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Major revision","date":"2024-10-11T04:14:51+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2024-08-29T10:03:59+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-05-31T14:01:20+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-04-03T10:51:04+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2024-03-04T09:17:46+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"34073d1c-ccaf-412a-b46a-48dd28a0639d","owner":[],"postedDate":"June 6th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-12-23T16:00:21+00:00","versionOfRecord":{"articleIdentity":"rs-3964706","link":"https://doi.org/10.1186/s13063-024-08704-7","journal":{"identity":"trials","isVorOnly":false,"title":"Trials"},"publishedOn":"2024-12-21 15:57:10","publishedOnDateReadable":"December 21st, 2024"},"versionCreatedAt":"2024-06-06 17:08:57","video":"","vorDoi":"10.1186/s13063-024-08704-7","vorDoiUrl":"https://doi.org/10.1186/s13063-024-08704-7","workflowStages":[]},"version":"v1","identity":"rs-3964706","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3964706","identity":"rs-3964706","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}