Drug use trends change rapidly among youth, leaving intervention experts struggling to respond promptly. Delays in responses can lead to preventable morbidity and mortality. The COVID-19 pandemic underscored the need for implementation science to facilitate rapid, equitable responses using existing treatment and prevention efforts. Existing, widely adopted evidence-based interventions (EBIs; e.g., the Michigan Model for Health™: MMH) are well suited to address emerging drug trends. We have a critical need to advance implementation strategies to optimize system responsiveness to these emerging drug issues. This research aims to design and test implementation strategies to (1) improve the responsiveness of school-based EBIs in addressing urgent issues and (2) find ways to support teachers in implementing updated EBIs, attending to unique considerations of schools serving economically disadvantaged students.

The research aims are as follows: aim 1: identify implementation gaps and best practices using After Action Review (a reflective process used by health organizations in responding to emergent public health events) using qualitative methods. Aim 2: design and pilot test RAPD (Rapid Adaptation to Prevent Drug use) based on aim 1 findings. RAPD refers to a novel set of implementation strategies designed to enhance the capacity of an existing, widely adopted evidence-based universal prevention curriculum (MMH) to respond to emerging drug issues among youth. We will pilot test RAPD in ten middle schools serving diverse student populations using a two-group, mixed method, cluster randomized controlled trial design. Aim 3: assess the costs and benefits of RAPD from multiple partner perspectives using a mixed methods approach.

This study focuses on designing and deploying implementation strategies to reduce the detrimental impact of emerging drugs and provide an infrastructure to make future adaptations that can be applied in other contexts. After Action Review (AAR) provides a valuable opportunity to review the statewide response to past drug use events, specifically the vaping crisis, using the MMH curriculum, which can systematically guide implementation strategy selection and deployment to meet identified gaps. The rationale for the proposed research is that designing and testing RAPD will advance implementation science in responding to urgent public health events and ensure equitable responses across youth populations.

ClinicalTrials.gov NCT05806840 .

Schools are a prime setting for the delivery of universal and targeted mental health interventions. Current school-based mental health interventions may not be developed to fully meet student mental health needs and co-production is needed to understand what young people really want. Despite this, research on school-based mental health interventions does not consistently engage in co-production, involving stakeholders, such as young people and schools, in the decision-making, development, evaluation and/or implementation stages. This highlights that transforming the development of school-based mental health interventions is crucial to meeting all stakeholders' needs. In this paper, we aim to briefly review an approach to co-production that can be used when conducting research on school-based mental health interventions that centre stakeholder voices to drive meaningful change. We describe a case study to showcase this approach.

We highlight recommendations and important elements to consider for each stakeholder when engaging in different levels of co-production, including young people, teachers, and schools. We provide practical examples of how this may look like in practice, theoretical underpinnings, and impact on outcomes. Our case study of co-producing a talk to improve mental health literacy in secondary school students is highlighted to demonstrate how a group of young people, teachers, epidemiologist, psychiatrist, and researchers can work together to develop school-based mental health interventions.

Co-production can be successfully conducted amongst researchers and stakeholders to develop school-based mental health interventions. Changes made to the talk were guided by synthesis of feedback that aligned with the balanced needs, perspectives, and opinions of all stakeholders. The use of this co-production approach in research on school-based mental health interventions with young people, teachers, and schools has important implications for research, service provision, and stakeholder empowerment.

Schools frequently adopt new interventions for each new public health issue, but this is both time- and resource-intensive. Adversity exposure is an example of a pervasive public health issue that emerged during Coronavirus Disease 2019 (COVID-19) with notable consequences, including an elevated risk of developing substance use disorders and mental illnesses. Adapting existing, universal, evidence-based interventions, such as the Michigan Model for HealthTM (MMH), by incorporating trauma-sensitive content is a promising approach to meet this need. We examined critical steps in promoting MMH adaptability as part of the Enhanced REP (Replicating Effective Programs) implementation strategy during the COVID-19 pandemic. We share usability testing from the 2020 to 2021 school year and describe how we apply the results to inform the group randomized trial pilot study. We applied key steps from implementation adaptation frameworks to integrate trauma-sensitive content as COVID-19 unfolded, documenting the process through field notes. We conducted initial usability testing with two teachers via interviews and used a rapid qualitative analysis approach. We conducted member checking by sharing the information with two health coordinators to validate results and inform additional curriculum refinement. We developed an adapted MMH curriculum to include trauma-sensitive content, with adaptations primarily centered on adding content, tailoring content, substituting content, and repeating/reinforcing elements across units. We designed adaptations to retain the core functional elements of MMH. Building foundational relationships and infrastructure supports opportunities to user-test intervention materials for Enhanced REP that enhance utility and relevance for populations that would most benefit. Enhanced REP is a promising strategy to use an existing evidence-based intervention to meet better the needs of youth exposed to adversity. Building on the foundations of existing evidence-based interventions, is vital to implementation success and achieving desired public health outcomes.

Intervention adaptation is often necessary to improve the fit between evidence-based practices/programs and implementation contexts. Existing frameworks describe intervention adaptation processes but do not provide detailed steps for prospectively designing adaptations, are designed for researchers, and require substantial time and resources to complete. A pragmatic approach to guide implementers through developing and assessing adaptations in local contexts is needed. The goal of this project was to develop Making Optimal Decisions for Intervention Flexibility during Implementation (MODIFI), a method for intervention adaptation that leverages human centered design methods and is tailored to the needs of intervention implementers working in applied settings with limited time and resources.

MODIFI was iteratively developed via a mixed-methods modified Delphi process. Feedback was collected from 43 implementation research and practice experts. Two rounds of data collection gathered quantitative ratings of acceptability and inclusion (Round 1) and feasibility (Round 2), as well as qualitative feedback regarding MODIFI revisions analyzed using conventional content analysis.

In Round 1, most participants rated all proposed components as essential but identified important avenues for revision which were incorporated into MODIFI prior to Round 2. Round 2 emphasized feasibility, where ratings were generally high and fewer substantive revisions were recommended. Round 2 changes largely surrounded operationalization of terms/processes and sequencing of content. Results include a detailed presentation of the final version of the three-step MODIFI method (Step 1: Learn about the users, local context, and intervention; Step 2: Adapt the intervention; Step 3: Evaluate the adaptation) along with a case example of its application.

MODIFI is a pragmatic method that was developed to extend the contributions of other research-based adaptation theories, models, and frameworks while integrating methods that are tailored to the needs of intervention implementers. Guiding teams to tailor evidence-based interventions to their local context may extend for whom, where, and under what conditions an intervention can be effective.

The research-practice gap between evidence-based intervention efficacy and its uptake in real-world contexts remains a central challenge for prevention and implementation science. Providing technical assistance (TA) is considered a crucial support mechanism that can help narrow the gap. However, empirical measurement of TA strategies and their variation is often lacking. The current study unpacks the black box of TA, highlighting different TA strategies, amounts, and their relation to intervention characteristics. First, we qualitatively categorized interactions between TA providers and implementers. Second, we explored how characteristics of implementing organizations and the intervention related to variations in the amount of TA delivered. Using data spanning six years, we analyzed over 10,000 encounters between TA providers and implementers. Content analysis yielded four distinct strategies: Consultation (27.2%), Coordination Logistics (24.5%), Monitoring (16.5%), and Resource Delivery (28.2%). Organizations with prior experience required less monitoring and resource delivery. Additionally, characteristics of the intervention were significantly associated with the amount of consultation, monitoring, coordination logistics, and resource delivery provided. The specific features of the intervention showed significant variation in their relation to TA strategies. These findings provide initial insights into the implications of intervention characteristics in determining how much of which TA strategies are needed to support implementations in real-world settings.

In this study we tested the usability, feasibility, social validity, and effectiveness of Engaged Learners, a behavior support program designed to be integrated into small group reading interventions. Participants included eight Grade 3 to 5 students with co-occurring reading difficulties and inattention. A concurrent multiple-baseline design was utilized to test the effects of Engaged Learners on engagement outcomes. Visual analysis and effect sizes indicated an improvement in engagement for seven students. Interventionists and students viewed the Engaged Learners program to be effective and socially valid. Limitations included lower than expected levels of fidelity for one interventionist and high student absenteeism. More research is needed to identify the extent to which Engaged Learners can support reading outcomes. Educators seeking an effective behavior support program that requires minimal training and coaching may consider integrating Engaged Learners into their small group reading instruction.

Intervention adaptation is often necessary to improve the fit between evidence-based practices/programs and implementation contexts. Existing frameworks describe intervention adaptation processes but do not provide detailed steps for prospectively designing adaptations, are designed for researchers, and require substantial time and resources to complete. A pragmatic approach to guide implementers through developing and assessing adaptations in local contexts is needed. The goal of this project was to develop Making Optimal Decisions for Intervention Flexibility during Implementation (MODIFI), a method for intervention adaptation that leverages human centered design methods and is tailored to the needs of intervention implementers working in applied settings with limited time and resources.

MODIFI was iteratively developed via a mixed-methods modified Delphi process. Feedback was collected from 43 implementation research and practice experts. Two rounds of data collection gathered quantitative ratings of acceptability (Round 1) and feasibility (Round 2), as well as qualitative feedback regarding MODIFI revisions analyzed using conventional content analysis.

In Round 1, most participants rated all proposed components as essential but identified important avenues for revision which were incorporated into MODIFI prior to Round 2. Round 2 emphasized feasibility, where ratings were generally high and fewer substantive revisions were recommended. Round 2 changes largely surrounded operationalization of terms/processes and sequencing of content. Results include a detailed presentation of the final version of the three-step MODIFI method (Step 1: Learn about the users, local context, and intervention; Step 2: Adapt the intervention; Step 3: Evaluate the adaptation) along with a case example of its application.

MODIFI is a pragmatic method that was developed to extend the contributions of other research-based adaptation theories, models, and frameworks while integrating methods that are tailored to the needs of intervention implementers. Guiding teams to tailor evidence-based interventions to their local context may extend for whom, where, and under what conditions an intervention can be effective.

There needs to be serious transformation of evidence-based interventions (EBIs) into real-world solutions; otherwise, EBIs will never achieve the intended public health impact. In a randomized trial, we reported effects of a redesigned anxiety program. Herein, we described the redesign process that led to the program. Survey data revealed provider preferences for school mental health anxiety services. Focus groups and prototype feedback sessions revealed service barriers to uptake, implementation, and sustainability along with corresponding enabling strategies. Prototype feedback sessions also focused on refinement and fine-tuning of the redesign. In the end, traditional EBI strategies were transformed and packaged into six lessons, lasting 20-30 minutes each, and amenable to delivery in small-group format. The redesign achieved the intended purpose of retaining elements from cognitive and behavior therapy and social skills training for the target population of the intervention (e.g., 3rd to 5th graders with heterogeneous anxiety problems - identified and referred). The streamlined EBI is accessible from PBS LearningMedia™ - a service that hosts public, research-based, and school-ready materials.

School-based drug use prevention programs have demonstrated notable potential to reduce the onset and escalation of drug use, including among youth at risk of poor outcomes such as those exposed to trauma. Researchers have found a robust relationship between intervention fidelity and participant (i.e., student) outcomes. Effective implementation of evidence-based interventions, such as the Michigan Model for HealthTM (MMH), is critical to achieving desired public health objectives. Yet, a persistent gap remains in what we know works and how to effectively translate these findings into routine practice. The objective of this study is to design and test a multi-component implementation strategy to tailor MMH to meet population needs (i.e., students exposed to trauma), and improve the population-context fit to enhance fidelity and effectiveness.

Using a 2-group, mixed-method randomized controlled trial design, this study will compare standard implementation versus Enhanced Replicating Effective Programs (REP) to deliver MMH. REP is a theoretically based implementation strategy that promotes evidence-based intervention (EBI) fidelity through a combination of EBI curriculum packaging, training, and as-needed technical assistance and is consistent with standard MMH implementation. Enhanced REP will tailor the intervention and training to integrate trauma-informed approaches and deploy customized implementation support (i.e., facilitation). The research will address the following specific aims: (1) design and test an implementation strategy (Enhanced REP) to deliver the MMH versus standard implementation and evaluate feasibility, acceptability, and appropriateness using mixed methods, (2) estimate the costs and cost-effectiveness of Enhanced REP to deliver MMH versus standard implementation.

This research will design and test a multi-component implementation strategy focused on enhancing the fit between the intervention and population needs while maintaining fidelity to MMH core functions. We focus on the feasibility of deploying the implementation strategy bundle and costing methods and preliminary information on cost input distributions. The substantive focus on youth at heightened risk of drug use and its consequences due to trauma exposure is significant because of the public health impact of prevention. Pilot studies of implementation strategies are underutilized and can provide vital information on designing and testing effective strategies by addressing potential design and methods uncertainties and the effects of the implementation strategy on implementation and student outcomes.

NCT04752189-registered on 8 February 2021 on ClinicalTrials.gov PRS.

People often prefer evidence-based psychosocial interventions (EBPIs) for mental health care; however, these interventions frequently remain unavailable to people in nonspecialty or integrated settings, such as primary care and schools. Previous research has suggested that usability, a concept from human-centered design, could support an understanding of the barriers to and facilitators of the successful adoption of EBPIs and support the redesign of EBPIs and implementation strategies.

This study aimed to identify and categorize usability issues in EBPIs and their implementation strategies.

We adapted a usability issue analysis and reporting format from a human-centered design. A total of 13 projects supported by the National Institute of Mental Health-funded Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness Center at the University of Washington used this format to describe usability issues for EBPIs and implementation strategies with which they were working. Center researchers used iterative affinity diagramming and coding processes to identify usability issue categories. On the basis of these categories and the underlying issues, we propose heuristics for the design or redesign of EBPIs and implementation strategies.

The 13 projects reported a total of 90 usability issues, which we categorized into 12 categories, including complex and/or cognitively overwhelming, required time exceeding available time, incompatibility with interventionist preference or practice, incompatibility with existing workflow, insufficient customization to clients/recipients, intervention buy-in (value), interventionist buy-in (trust), overreliance on technology, requires unavailable infrastructure, inadequate scaffolding for client/recipient, inadequate training and scaffolding for interventionists, and lack of support for necessary communication. These issues range from minor inconveniences that affect a few interventionists or recipients to severe issues that prevent all interventionists or recipients in a setting from completing part or all of the intervention. We propose 12 corresponding heuristics to guide EBPIs and implementation strategy designers in preventing and addressing these usability issues.

Usability issues were prevalent in the studied EBPIs and implementation strategies. We recommend using the lens of usability evaluation to understand and address barriers to the effective use and reach of EBPIs and implementation strategies.

RR2-10.2196/14990.

Effective implementation of evidence-based prevention interventions in schools is vital to reducing the burden of drug use and its consequences. Universal prevention interventions often fail to achieve desired public health outcomes due to poor implementation. One central reason for suboptimal implementation is the limited fit between the intervention and the setting. Research is needed to increase our understanding of how intervention characteristics and context influence intervention implementation in schools to design implementation strategies that will address barriers and improve public health impact.

Using a convergent mixed methods design we examined qualitative and quantitative data on implementation determinants for an evidence-based health curriculum, the Michigan Model for HealthTM (MMH) from the perspective of health teachers delivering the curriculum in high schools across the state. We examined data strands independently and integrated them by investigating data alignment, expansion, and divergence.

We identified three mixed methods domains: (1) Acceptability, (2) intervention-context fit, and (3) adaptability. We found alignment across data strands as teachers reporting low acceptability also reported low fidelity. The fit between student needs and the curriculum predicted fidelity (expansion). Teachers mentioned instances of poor intervention-context fit (discordance), including when meeting the needs of trauma-exposed youth and keeping updated on youth drug use trends. Teachers reported high adaptability (concordance) but also instances when adaptation was challenging (discordance).

This investigation advances implementation research by deepening our understanding of implementation determinants for an evidence-based universal prevention intervention in schools. This will support designing effective implementation strategies to address barriers and advance the public health impact of interventions that address important risk and protective factors for all youth.

(1) What is Already Known About the Topic? While many evidence-based interventions (EBIs) exist to address key health issues among youth including substance use and mental health, few of these interventions are effectively implemented in community settings, such as schools. Notable multilevel barriers exist to implement universal prevention in schools. Researchers identify that misalignment between the intervention and the context is a key reason why many implementation efforts do not achieve desired outcomes. (2) What Does This Paper Add? This paper combines the strengths of qualitative and quantitative research methods to identify and understand challenges to intervention-context fit for a comprehensive health curriculum, the Michigan Model for HealthTM (MMH) which is widely adopted throughout Michigan, from the perspective of end users. This paper also utilizes the consolidated framework for implementation research and implementation outcomes framework to guide our understanding of implementing complex interventions and key barriers to implementation in schools. This research provides a foundation to design effective strategies that will balance curriculum fidelity and adaptation to achieve public health objectives. (3) What are the Implications for Practice, Research, or Policy? We need implementation strategies that guide flexibility and fidelity in EBI delivery in schools. While overall teachers felt the curriculum was adaptable and met student needs, they also mentioned specific instances when they would benefit from additional implementation support, such as making adaptations to meet the needs of trauma-exposed youth and keeping up-to-date with emerging drugs. Implementation strategies designed to address these challenges can improve fidelity and ultimately student well-being.

This study examined how teachers discuss various factors as impacting their ability to execute with fidelity the Michigan Model for Health (MMH), an evidence-based health universal prevention curriculum widely adopted throughout Michigan. Researchers have found a robust relationship between fidelity and participant outcomes, including in schools. While previous studies have identified barriers that inhibit fidelity, few have focused on identifying key barriers and deepening our understanding of how these factors influence intervention fidelity. We conducted a thematic analysis using the reflexive thematic approach to identify key barriers and facilitators and deepen our understanding of how these factors influence MMH implementation. Guided by the Consolidated Framework for Implementation Research (CFIR) and the Implementation Outcomes Framework, we conducted semistructured interviews with 23 high school health teachers across Michigan. Teachers identified intervention characteristics (e.g., design quality, packaging, and program adaptability), student needs (e.g., trauma exposure, substances), and the fit between the intervention and the context as factors that contributed to acceptability. They also discussed the curriculum and its alignment with their teaching style and/or experiences as contributing to fidelity. Teachers shared how they would often go "off protocol" to improve intervention-context fit and meet students' needs. Our results identified acceptability, a perceptual implementation outcome, as demonstrating an important role in shaping the relationship between CFIR factors and fidelity. Results provide guidance for systematically designing implementation strategies that address key barriers to improve acceptability, enhance fidelity, and ultimately achieve desired public health objectives.

Implementation strategies have flourished in an effort to increase integration of research evidence into clinical practice. Most strategies are complex, socially mediated processes. Many are complicated, expensive, and ultimately impractical to deliver in real-world settings. The field lacks methods to assess the extent to which strategies are usable and aligned with the needs and constraints of the individuals and contexts who will deliver or receive them. Drawn from the field of human-centered design, cognitive walkthroughs are an efficient assessment method with potential to identify aspects of strategies that may inhibit their usability and, ultimately, effectiveness. This article presents a novel walkthrough methodology for evaluating strategy usability as well as an example application to a post-training consultation strategy to support school mental health clinicians to adopt measurement-based care.

The Cognitive Walkthrough for Implementation Strategies (CWIS) is a pragmatic, mixed-methods approach for evaluating complex, socially mediated implementation strategies. CWIS includes six steps: (1) determine preconditions; (2) hierarchical task analysis; (3) task prioritization; (4) convert tasks to scenarios; (5) pragmatic group testing; and (6) usability issue identification, classification, and prioritization. A facilitator conducted two group testing sessions with clinician users (N = 10), guiding participants through 6 scenarios and 11 associated subtasks. Clinicians reported their anticipated likelihood of completing each subtask and provided qualitative justifications during group discussion. Following the walkthrough sessions, users completed an adapted quantitative assessment of strategy usability.

Average anticipated success ratings indicated substantial variability across participants and subtasks. Usability ratings (scale 0-100) of the consultation protocol averaged 71.3 (SD = 10.6). Twenty-one usability problems were identified via qualitative content analysis with consensus coding, and classified by severity and problem type. High-severity problems included potential misalignment between consultation and clinical service timelines as well as digressions during consultation processes.

CWIS quantitative usability ratings indicated that the consultation protocol was at the low end of the "acceptable" range (based on norms from the unadapted scale). Collectively, the 21 resulting usability issues explained the quantitative usability data and provided specific direction for usability enhancements. The current study provides preliminary evidence for the utility of CWIS to assess strategy usability and generate a blueprint for redesign.