Overdose deaths before and during the COVID-19 pandemic in a US county.

Introduction: Globally, overdose deaths increased near the beginning of the COVID-19 pandemic, which created availability and access barriers to addiction and social services. Especially in times of a crisis like a pandemic, local exposures, service availability and access, and system responses have major influence on people who use drugs. For policy makers to be effective, an understanding at the local level is needed. Methods: This retrospective epidemiologic study from 2019 through 2021 compares immediate and 20-months changes in overdose deaths from the pandemic start to 16 months before its arrival in Pinellas County, FL We examine toxicologic death records of 1,701 overdoses to identify relations with interdiction, and service delivery. Results: There was an immediate 49% increase (95% CI 23-82%, p < 0.0001) in overdose deaths in the first month following the first COVID deaths. Immediate increases were found for deaths involving alcohol (171%), heroin (108%), fentanyl (78%), amphetamines (55%), and cocaine (45%). Overdose deaths remained 27% higher (CI 4-55%, p = 0.015) than before the pandemic through 2021.Abrupt service reductions occurred when the pandemic began: in-clinic methadone treatment dropped by two-thirds, counseling by 38%, opioid seizures by 29%, and drug arrests by 56%. Emergency transport for overdose and naloxone distributions increased at the pandemic onset (12%, 93%, respectively) and remained higher through 2021 (15%, 377%,). Regression results indicate that lower drug seizures predicted higher overdoses, and increased 911 transports predicted higher overdoses. The proportion of excess overdose deaths to excess non-COVID deaths after the pandemic relative to the year before was 0.28 in Pinellas County, larger than 75% of other US counties. Conclusions: Service and interdiction interruptions likely contributed to overdose death increases during the pandemic. Relaxing restrictions on medical treatment for opioid addiction and public health interventions could have immediate and long-lasting effects when a major disruption, such as a pandemic, occurs. County level data dashboards comprised of overdose toxicology, and interdiction and service data, can help explain changes in overdose deaths. As a next step in predicting which policies and practices will best reduce local overdoses, we propose using simulation modeling with agent-based models to examine complex interacting systems.

US payment policy for medications to treat opioid use disorder: landscape and opportunities.

Offering patients medications for opioid use disorder (MOUD) is the standard of care for opioid use disorder (OUD), but an estimated 75%-90% of people with OUD who could benefit from MOUD do not receive medication. Payment policy, defined as public and private payers' approaches to covering and reimbursing providers for MOUD, is 1 contributor to this treatment gap. We conducted a policy analysis and qualitative interviews (n = 21) and surveys (n = 31) with US MOUD payment policy experts to characterize MOUD insurance coverage across major categories of US insurers and identify opportunities for reform and innovation. Traditional Medicare, Medicare Advantage, and Medicaid all provide coverage for at least 1 formulation of buprenorphine, naltrexone, and methadone for OUD. Private insurance coverage varies by carrier and by plan, with methadone most likely to be excluded. The experts interviewed cautioned against rigid reimbursement models that force patients into one-size-fits-all care and endorsed future development and adoption of value-based MOUD payment models. More than 70% of experts surveyed reported that Medicare, Medicaid, and private insurers should increase payment for office- and opioid treatment program-based MOUD. Validation of MOUD performance metrics is needed to support future value-based initiatives.

Engaging primary care clinicians in the selection of implementation strategies for toddler social-emotional health promotion in community health centers.

BACKGROUND: Social-emotional risk for subsequent behavioral health problems can be identified at toddler age, a period where prevention has a heightened impact. This study aimed to meaningfully engage pediatric clinicians, given the emphasis on health promotion and broad reach of primary care, to prepare an Implementation Research Logic Model to guide the implementation of a screening and referral process for toddlers with elevated social-emotional risk. METHOD: Using an adaptation of a previously published community partner engagement method, six pediatricians from community health centers (CHCs) comprised a Clinical Partner Work Group. The group was engaged in identifying determinants (barriers/facilitators), selecting and specifying strategies, strategy-determinant matching, a modified Delphi approach for strategy prioritization, and user-centered design methods. The data gathered from individual interviews, two group sessions, and a follow-up survey resulted in a completed Implementation Research Logic Model. RESULTS: The Clinical Partner Work Group identified 16 determinants, including barriers (e.g., patient access to electronic devices) and facilitators (e.g., clinician buy-in). They then selected and specified 14 strategies, which were prioritized based on ratings of feasibility, effectiveness, and priority. The highest-rated strategies (e.g., integration of the screener into the electronic health record) provided coverage of all identified barriers and comprised the primary implementation strategy "package" to be used and tested. CONCLUSIONS: Clinical partners provided important context and insights for implementation strategy selection and specification to support the implementation of social-emotional risk screening and referral in pediatric primary care. The methodology described herein can improve partner engagement in implementation efforts and increase the likelihood of success. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Retrospective Psychometrics and Effect Heterogeneity in Integrated Data Analysis: Commentary on the Special Issue.

The current special issue of Prevention Science indicates that momentum in using individual participant data (IPD) and integrative data analysis (IDA) to combine and synthesize findings in prevention science has accelerated over the past decade. In this commentary, we focus on two general themes involving methods for harmonizing measures and findings of effect heterogeneity. We describe methods for harmonization as retrospective psychometrics, requiring that we attend to the assumptions necessary for accurate measurement, but adjust our methods given the constraints of working with existing datasets that often involve different measures in different studies. We point to novel approaches for increasing confidence that semantic matching and empirical modeling used in these studies will yield accurate and valid measurements that can be combined in IDA. We also review findings about effect heterogeneity, emphasizing the importance of using etiologic and action theories to identify and evaluate sources of such effects. We note that all of the papers in this issue deserve careful attention, as they illustrate how prevention scientists are approaching the complexities of IDA and exploring novel methods for overcoming its challenges.

"The library is so much more than books": considerations for the design and implementation of teen digital mental health services in public libraries.

Background: Adolescence is a vulnerable developmental period, characterized by high rates of mental health concerns, yet few adolescents receive treatment. Public libraries support adolescents by providing them with access to teen programming, technological resources, and have recently been providing mental health services. Digital mental health (DMH) services may help libraries provide scalable mental health solutions for their adolescent patrons and could be well positioned to address the mental health needs of historically underrepresented racial and ethnic (HURE) adolescents; however, little research has been conducted on the compatibility of DMH services with adolescent patron mental health needs or resource needs of library workers supporting them. Methods: The research team formed a partnership with a public library, which serves a large HURE adolescent population. We conducted needs assessment and implementation readiness interviews with 17 library workers, including leadership, librarians, and workers with specialized areas of practice. Interview questions focused on library infrastructure, as well as library needs and preferences around the design and implementation of DMH services for adolescents. We used the Consolidated Framework for Implementation Research as guiding implementation determinant framework to code and analyze the interview transcripts. Results: Our findings revealed library workers play an important role in guiding patrons to desired resources and share a goal of implementing adolescent DMH resources into the library and elevating marginalized adolescents' voices. Existing library resources, such as the library's role as a safe space for adolescents in the community, close relationships with external and community organizations, and availability of no-cost technological resources, could help facilitate the implementation of DMH services. Barriers related to community buy-in, mental health stigma, and library worker confidence in supporting adolescent mental health could affect service implementation. Conclusions: Our findings suggest public libraries are highly promising settings to deploy DMH services for adolescents. We identified important determinants that may impact the implementation of DMH services in public library settings. Special considerations are needed to design services to meet the mental health needs of HURE adolescent populations and those adolescents' most experiencing health inequities.

PrEP Persistence Support and Monitoring in Areas of High HIV Burden in the Midwestern United States.

Monitoring pre-exposure prophylaxis (PrEP) metrics can guide service delivery yet does not occur routinely. We developed a survey to understand current practices for monitoring PrEP at PrEP-providing organizations in Illinois and Missouri. The survey was distributed from September through November 2020; 26 organizations participated. Most respondents indicated ongoing efforts to screen for PrEP eligibility (66.7%), link to care (87.5%), and retain clients in care (70.8%); 70.8% reported collecting data on PrEP initiation, 41.7% on retention in care, and 37.5% on missed visits. Barriers to monitoring PrEP metrics included lack of IT support (69.6%), manual processes (69.6%), and lack of staff resources (65.2%). Most respondents offered clients support for PrEP retention and adherence and wanted to expand interventions for PrEP persistence, yet fewer monitored corresponding metrics. To enhance PrEP implementation, organizations should improve monitoring and evaluation of PrEP metrics along the entire continuum and respond with appropriate services to support clients.

Normalization of Prevention Principles and Practices to Reduce Substance Use Disorders Through an Integrated Dissemination and Implementation Framework.

Major research breakthroughs over the past 30 years in the field of substance use prevention have served to: (1) enhance understanding of pharmacological effects on the central and peripheral nervous systems and the health and social consequences of use of psychoactive substances, particularly for children and adolescents; (2) delineate the processes that increase vulnerability to or protect from initiation of substance use and progression to substance use disorders (SUDs) and, based on this understanding, (3) develop effective strategies and practices to prevent the initiation and escalation of substance use. The challenge we now face as a field is to "normalize" what we have learned from this research so that it is incorporated into the work of those involved in supporting, planning, and delivering prevention programming to populations around the world, is integrated into health and social service systems, and helps to shape public policies. But we wish to go further, to incorporate these effective prevention practices into everyday life and the mind-sets of the public, particularly parents and educators. This paper reviews the advances that have been made in the field of prevention and presents a framework and recommendations to achieve these objectives generated during several meetings of prevention and implementation science researchers sponsored by the International Consortium of Universities for Drug Demand Reduction (ICUDDR) that guides a roadmap to achieve "normalization."

eHealth Familias Unidas Mental Health: Protocol for an effectiveness-implementation hybrid Type 1 trial to scale a mental health preventive intervention for Hispanic youth in primary care settings.

This article focuses on the rationale, design and methods of an effectiveness-implementation hybrid type I randomized trial of eHealth Familias Unidas Mental Health, a family-based, online delivered intervention for Hispanic families to prevent/reduce depressive and anxious symptoms, suicide ideation/behaviors, and drug use in Hispanic youth. Utilizing a rollout design with 18 pediatric primary care clinics and 468 families, this study addresses intervention effectiveness, implementation research questions, and intervention sustainment, to begin bridging the gap between research and practice in eliminating mental health and drug use disparities among Hispanic youth. Further, we will examine whether intervention effects are partially mediated by improved family communication and reduced externalizing behaviors, including drug use, and moderated by parental depression. Finally, we will explore whether the intervention's impact on mental health and drug use, as well as sustainment of the intervention in clinics, varies by quality of implementation at clinic and clinician levels. Trail registration: ClinicalTrials.gov Identifier: NCT05426057, First posted June 21, 2022.

Promoting Evidence-Based Practice: The Influence of Novel Structural Change to Accelerate Translational Rehabilitation.

OBJECTIVE: To evaluate changes in clinicians' use of evidence-based practice (EBP), openness toward EBP, and their acceptance of organizational changes after a rehabilitation hospital transitioned to a new facility designed to accelerate clinician-researcher collaborations. DESIGN: Three repeated surveys of clinicians before, 7-9 months, and 2.5 years after transition to the new facility. SETTING: Inpatient rehabilitation hospital. PARTICIPANTS: Physicians, nurses, therapists, and other health care professionals (n=410, 442, and 448 respondents at Times 1, 2, and 3, respectively). INTERVENTIONS: Implementation of physical (architecture, design) and team-focused (champions, leaders, incentives) changes in a new model of care to promote clinician-researcher collaborations. MAIN OUTCOME MEASURES: Adapted versions of the Evidence-Based Practice Questionnaire (EBPQ), the Evidence-Based Practice Attitudes Scale (EBPAS), and the Organizational Change Recipients' Beliefs Scale (OCRBS) were used. Open-ended survey questions were analyzed through exploratory content analysis. RESULTS: Response rates at Times 1, 2, and 3 were 67% (n=410), 69% (n=422), and 71% (n=448), respectively. After accounting for familiarity with the model of care, there was greater reported use of EBP at Time 3 compared with Time 2 (adjusted meant2=3.51, standard error (SE)=0.05; adj. meant3=3.64, SE=0.05; P=.043). Attitudes toward EBPs were similar over time. Acceptance of the new model of care was lower at Time 2 compared with Time 1, but rebounded at Time 3 (adjusted meant1=3.44, SE=0.04; adj. meant2=3.19, SE=0.04; P<.0001; adj. meant3=3.51, SE=0.04; P<.0001). Analysis of open-ended responses suggested that clinicians' optimism for the model of care was greater over time, but continued quality improvement should focus on cultivating communication between clinicians and researchers. CONCLUSIONS: Accelerating clinician-researcher collaborations in a rehabilitation setting requires sustained effort for successful implementation beyond novel physical changes. Organizations must be responsive to clinicians' changing concerns to adapt and sustain a collaborative translational medicine model and allow sufficient time, probably years, for such transitions to occur.

Keep It Up! 3.0: Study protocol for a type III hybrid implementation-effectiveness cluster-randomized trial.

BACKGROUND: Despite evidence that eHealth approaches can be effective in reducing HIV risk, their implementation requirements for public health scale up are not well established, and effective strategies to bring these programs into practice are still unknown. Keep It Up! (KIU!) is an online program proven to reduce HIV risk among young men who have sex with men (YMSM) and ideal candidate to develop and evaluate novel strategies for implementing eHealth HIV prevention programs. KIU! 3.0 is a Type III Hybrid Effectiveness-Implementation cluster randomized trial designed to 1) compare two strategies for implementing KIU!: community-based organizations (CBO) versus centralized direct-to-consumer (DTC) recruitment; 2) examine the effect of strategies and determinants on variability in implementation success; and 3) develop materials for sustainment of KIU! after the trial concludes. In this article, we describe the approaches used to achieve these aims. METHODS: Using county-level population estimates of YMSM, 66 counties were selected and randomized 2:1 to the CBO and DTC approaches. The RE-AIM model was used to drive outcome measurements, which were collected from CBO staff, YMSM, and technology providers. Mixed-methods research mapped onto the domains of the Consolidated Framework for Implementation Research will examine determinants and their relationship with implementation outcomes. DISCUSSION: In comparing our implementation recruitment models, we are examining two strategies which have shown effectiveness in delivering health technology interventions in the past, yet little is known about their comparative advantages and disadvantages in implementation. The results of the trial will further the understanding of eHealth prevention intervention implementation.

Comparative effectiveness of a mindfulness-based intervention (M-Body) on depressive symptoms: study protocol of a randomized controlled trial in a Federally Qualified Health Center (FQHC).

BACKGROUND: Mindfulness-based interventions have been shown to improve psychological outcomes including stress, anxiety, and depression in general population studies. However, effectiveness has not been sufficiently examined in racially and ethnically diverse community-based settings. We will evaluate the effectiveness and implementation of a mindfulness-based intervention on depressive symptoms among predominantly Black women at a Federally Qualified Health Center in a metropolitan city. METHODS: In this 2-armed, stratified, individually randomized group-treated controlled trial, 274 English-speaking participants with depressive symptoms ages 18-65 years old will be randomly assigned to (1) eight weekly, 90-min group sessions of a mindfulness-based intervention (M-Body), or (2) enhanced usual care. Exclusion criteria include suicidal ideation in 30 days prior to enrollment and regular (>4x/week) meditation practice. Study metrics will be assessed at baseline and 2, 4, and 6 months after baseline, through clinical interviews, self-report surveys, and stress biomarker data including blood pressure, heart rate, and stress related biomarkers. The primary study outcome is depressive symptom score after 6 months. DISCUSSION: If M-Body is found to be an effective intervention for adults with depressive symptoms, this accessible, scalable treatment will widely increase access to mental health treatment in underserved, racial/ethnic minority communities. TRIAL REGISTRATION: ClinicalTrials.gov NCT03620721. Registered on 8 August 2018.

Utilization of genetic testing in men with advanced prostate cancer.

BACKGROUND: Genetic evaluation of men with advanced prostate cancer is recognized as imperative both to guide treatment decisions and to trigger cascade genetic testing of family members. Here we investigate utilization patterns of genetic testing among a contemporary cohort of men with advanced prostate cancer at our institution. METHODS: We queried the Northwestern Electronic Data Warehouse from January 2021 to present for all men diagnosed with National Comprehensive Cancer Network high-risk/very high-risk, regional, or metastatic prostate cancer. Patients were excluded from analyses if treated at an outside institution and/or presented for a second opinion evaluation. Statistics were performed using t-test, Chi-squared test, and univariable and multivariable logistic regression with significance defined as p < 0.05. RESULTS: Atotal of 320 men (52.5%) had local/regional disease and 290 (47.5%) had metastatic disease, 53 (18.3%) of whom had castrate resistant prostate cancer. Rates of germline genetic testing rate were low in patients with localized disease (9.4%) and metastatic disease (34.1%). Only 19 (35.8%) men diagnosed with metastatic castrate resistant prostate cancer underwent germline genetic evaluation. Germline testing was most frequently discussed or ordered by medical oncologists (52%) followed by urologists (20%). Men who underwent germline testing were younger (p < 0.001), more likely to have Medicaid or private insurance (p = 0.002), and more likely to have metastatic disease (p < 0.001). There were no statistically significant differences in baseline PSA, ethnicity, race, or castration sensitivity status. Age (odds ratio [OR]: 0.94, 95% confidence interval [CI]: 0.91-0.97, p < 0.001) and metastatic disease (OR: 5.71, 95% CI: 3.63-9.22, p < 0.001) were significant independent predictors of genetic testing on multivariable logistic regression. CONCLUSIONS: Here we report that utilization of genetic testing is associated with metastatic disease and inversely associated with age. Overall, utilization rates of genetic testing remain low in all patient groups, including in the metastatic castrate resistant setting, where genetic testing can identify patients with homologous recombination repair deficiency who may benefit from use of targeted therapeutics such as PARP inhibitors. Genetic testing in men with aggressive prostate cancer is critical and barriers to routine implementation of testing require further study to develop strategies to improve utilization rates.

Implementation Barriers and Experiences of Eligible Patients Who Failed to Enroll in Collaborative Care for Depression and Anxiety.

BACKGROUND: Effective and efficient implementation of the Collaborative Care Model (CoCM) for depression and anxiety is imperative for program success. Studies examining barriers to implementation often omit patient perspectives. OBJECTIVES: To explore experiences and attitudes of eligible patients referred to CoCM who declined participation or were unable to be reached, and identify implementation barriers to inform strategies. DESIGN: Convergent mixed-methods study with a survey and interview. PARTICIPANTS: Primary care patients at an academic medical center who were referred to a CoCM program for anxiety and depression by their primary care clinician (PCC) but declined participation or were unable to be reached by the behavioral health care manager to initiate care (n = 80). Interviews were conducted with 45 survey respondents. MAIN MEASURES: Survey of patients' referral experiences and behavioral health preferences as they related to failing to enroll in the program. Interview questions were developed using the Consolidated Framework for Implementation Research version 2.0 (CFIR 2.0) to identify implementation barriers to enrollment. KEY RESULTS: Survey results found that patients were uncertain about insurance coverage, did not understand the program, and felt services were not necessary. Referred patients who declined participation were concerned about how their mental health information would be used and preferred treatment without medication. Men agreed more that they did not need services. Qualitative results exhibited a variety of implementation determinants (n = 23) across the five CFIR 2.0 domains. Barriers included mental health stigma, perceiving behavioral health as outside of primary care practice guidelines, short or infrequent primary care appointments, prioritizing physical health over mental health, receiving inaccurate program information, low motivation to engage, and a less established relationship with their PCC. CONCLUSIONS: Multiple barriers to enrollment led to failing to link patients to care, which can inform implementation strategies to address the patient-reported experiences and concerns.

Refining an Implementation Strategy to Enhance the Reach of HIV-Prevention and Behavioral Health Treatments to Latino Men Who Have Sex with Men.

Background: Latino men who have sex with men (LMSM) experience HIV and behavioral health disparities. Yet, evidence-based interventions, such as pre-exposure prophylaxis (PrEP) and behavioral health treatments, have not been equitably scaled up to meet LMSM needs. To address quality of life and the public health importance of HIV prevention, implementation strategies to equitably scale up these interventions to LMSM need to be developed. This study identifies themes for developing culturally grounded implementation strategies to increase uptake of evidence-based HIV prevention and behavioral health treatments among LMSM. Methods: Participants included 13 LMSM and 12 stakeholders in Miami, an HIV epicenter. Feedback regarding the content, design, and format of an implementation strategy to scale up HIV-prevention and behavioral health services to LMSM were collected via focus groups (N=3) and individual interviews (N=3). Themes were inductively identified across the Health Equity Implementation Framework (HEIF) domains. Results: Analyses revealed five higher order themes regarding the design, content, and format of the implementation strategy: cultural context, relationships and networks, navigation of health information and systems, resources and models of service delivery, and motivation to engage. Themes were applicable across HEIF domains, meaning that the same theme could have implications for both the development and implementation of the implementation strategy. Conclusions: Findings highlight the importance of addressing culturally specific factors, leveraging relational networks, facilitating navigation of health systems, tailoring to available resources, and building consumer and implementer motivation in order to refine an implementation strategy for reducing mental health burden and achieving HIV health equity among LMSM.

Agent-based model projections for reducing HIV infection among MSM: Prevention and care pathways to end the HIV epidemic in Chicago, Illinois.

Our objective is to improve local decision-making for strategies to end the HIV epidemic using the newly developed Levers of HIV agent-based model (ABM). Agent-based models use computer simulations that incorporate heterogeneity in individual behaviors and interactions, allow emergence of systemic behaviors, and extrapolate into the future. The Levers of HIV model (LHM) uses Chicago neighborhood demographics, data on sex-risk behaviors and sexual networks, and data on the prevention and care cascades, to model local dynamics. It models the impact of changes in local preexposure prophylaxis (PrEP) and antiretroviral treatment (ART) (ie, levers) for meeting Illinois' goal of "Getting to Zero" (GTZ) -reducing by 90% new HIV infections among men who have sex with men (MSM) by 2030. We simulate a 15-year period (2016-2030) for 2304 distinct scenarios based on 6 levers related to HIV treatment and prevention: (1) linkage to PrEP for those testing negative, (2) linkage to ART for those living with HIV, (3) adherence to PrEP, (4) viral suppression by means of ART, (5) PrEP retention, and (6) ART retention. Using tree-based methods, we identify the best scenarios at achieving a 90% HIV infection reduction by 2030. The optimal scenario consisted of the highest levels of ART retention and PrEP adherence, next to highest levels of PrEP retention, and moderate levels of PrEP linkage, achieved 90% reduction by 2030 in 58% of simulations. We used Bayesian posterior predictive distributions based on our simulated results to determine the likelihood of attaining 90% HIV infection reduction using the most recent Chicago Department of Public Health surveillance data and found that projections of the current rate of decline (2016-2019) would not achieve the 90% (p = 0.0006) reduction target for 2030. Our results suggest that increases are needed at all steps of the PrEP cascade, combined with increases in retention in HIV care, to approach 90% reduction in new HIV diagnoses by 2030. These findings show how simulation modeling with local data can guide policy makers to identify and invest in efficient care models to achieve long-term local goals of ending the HIV epidemic.

Re-envisioning, Retooling, and Rebuilding Prevention Science Methods to Address Structural and Systemic Racism and Promote Health Equity.

The historic momentum from national conversations on the roots and current impacts of racism in the USA presents an incredible window of opportunity for prevention scientists to revisit how common theories, measurement tools, methodologies, and interventions can be radically re-envisioned, retooled, and rebuilt to dismantle racism and promote equitable health for minoritized communities. Recognizing this opportunity, the NIH-funded Prevention Science and Methodology Group (PSMG) launched a series of presentations focused on the role of Prevention Science to address racism and discrimination guided by a commitment to social justice and health equity. The current manuscript aims to advance the field of Prevention Science by summarizing key issues raised during the series' presentations and proposing concrete research priorities and steps that hold promise for promoting health equity by addressing systemic racism. Being anti-racist is an active practice for all of us, whether we identify as methodologists, interventionists, practitioners, funders, community members, or an intersection of these identities. We implore prevention scientists and methodologists to take on these conversations with us to promote science and practice that offers every life the right to live in a just and equitable world.

Accounting for Context in Randomized Trials after Assignment.

Many preventive trials randomize individuals to intervention condition which is then delivered in a group setting. Other trials randomize higher levels, say organizations, and then use learning collaboratives comprised of multiple organizations to support improved implementation or sustainment. Other trials randomize or expand existing social networks and use key opinion leaders to deliver interventions through these networks. We use the term contextually driven to refer generally to such trials (traditionally referred to as clustering, where groups are formed either pre-randomization or post-randomization - i.e., a cluster-randomized trial), as these groupings or networks provide fixed or time-varying contexts that matter both theoretically and practically in the delivery of interventions. While such contextually driven trials can provide efficient and effective ways to deliver and evaluate prevention programs, they all require analytical procedures that take appropriate account of non-independence, something not always appreciated. Published analyses of many prevention trials have failed to take this into account. We discuss different types of contextually driven designs and then show that even small amounts of non-independence can inflate actual Type I error rates. This inflation leads to rejecting the null hypotheses too often, and erroneously leading us to conclude that there are significant differences between interventions when they do not exist. We describe a procedure to account for non-independence in the important case of a two-arm trial that randomizes units of individuals or organizations in both arms and then provides the active treatment in one arm through groups formed after assignment. We provide sample code in multiple programming languages to guide the analyst, distinguish diverse contextually driven designs, and summarize implications for multiple audiences.

Don't Get Lost in Translation: Integrating Developmental and Implementation Sciences to Accelerate Real-World Impact on Children's Development, Health, and Wellbeing.

Translation of developmental science discoveries is impeded by numerous barriers at different stages of the research-to-practice pipeline. Actualization of the vast potential of the developmental sciences to improve children's health and development in the real world is imperative but has not yet been fully realized. In this commentary, we argue that an integrated developmental-implementation sciences framework will result in a translational mindset essential for accelerating real world impact. We delineate key principles and methods of implementation science of salience to the developmental science audience, lay out a potential synthesis between implementation and developmental sciences, provide an illustration of the Mental Health, Earlier Partnership (MHE-P), and set actionable steps for realization. Blending these approaches along with wide-spread adoption of the translational mindset has transformative potential for population-level impact of developmental science discovery.

A stepped-wedge randomized trial investigating the effect of the Leadership and Organizational Change for Implementation (LOCI) intervention on implementation and transformational leadership, and implementation climate.

BACKGROUND: This study evaluates the Leadership and Organizational Change for Implementation (LOCI) strategy and its effect on implementation leadership, transformational leadership, and implementation climate. METHODS: A stepped wedge cluster randomized study design enrolling 47 first-level leaders from child- and adult-specialized mental health clinics within Norwegian health trusts across three cohorts. All therapists (n = 790) received training in screening of trauma exposure and posttraumatic stress, and a subgroup of therapists (n = 248) received training in evidence-based treatment methods for posttraumatic stress disorder (PTSD). First-level leaders and therapists completed surveys at baseline, 4, 8-, 12-, 16-, and 20-months assessing leadership and implementation climate. General linear mixed-effects models were used to investigate whether the LOCI strategy would lead to greater therapist-rated scores on implementation leadership, transformational leadership, and implementation climate. RESULTS: After introducing the LOCI strategy, there was a significant increase in therapist-rated implementation and transformational leadership and implementation climate. The increase was sustained at all measurement time points compared to non-LOCI conditions, which demonstrated a steady decrease in scores before LOCI. CONCLUSIONS: The LOCI strategy can develop better transformational and implementation leadership skills and contribute to a more positive implementation climate, which may enhance successful EBP implementation. Thus, LOCI can help leaders create an organizational context conducive for effective EBP implementation. TRIAL REGISTRATION: Retrospectively registered: ClinicalTrials NCT03719651 , 25th of October 2018. The trial protocol can be accessed from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6417075/ .

High-Fidelity Agent-Based Modeling to Support Prevention Decision-Making: an Open Science Approach.

Preventing adverse health outcomes is complex due to the multi-level contexts and social systems in which these phenomena occur. To capture both the systemic effects, local determinants, and individual-level risks and protective factors simultaneously, the prevention field has called for adoption of system science methods in general and agent-based models (ABMs) specifically. While these models can provide unique and timely insight into the potential of prevention strategies, an ABM's ability to do so depends strongly on its accuracy in capturing the phenomenon. Furthermore, for ABMs to be useful, they need to be accepted by and available to decision-makers and other stakeholders. These two attributes of accuracy and acceptability are key components of open science. To ensure the creation of high-fidelity models and reliability in their outcomes and consequent model-based decision-making, we present a set of recommendations for adopting and using this novel method. We recommend ways to include stakeholders throughout the modeling process, as well as ways to conduct model verification, validation, and replication. Examples from HIV and overdose prevention work illustrate how these recommendations can be applied.