Effects of a Health Education Intervention for COVID-19 Prevention in Latinx Communities: A Cluster-Randomized Controlled Trial.

To promote COVID-19 preventive attitudes and behaviors among Latinx individuals, researchers and community partners implemented a culturally tailored health education intervention across 12 Oregon counties from February 2021 through April 2022. We did not identify any significant intervention effects on preventive attitudes and behaviors but did observe significant decreases in psychological distress. Although Latinx individuals' preventive attitudes and behaviors were not associated with the health education intervention, findings suggest the intervention has value in promoting their well-being (ClinicalTrials.gov Identifier: NCT04793464). (Am J Public Health. 2022;112(S9):S923-S927. https://doi.org/10.2105/AJPH.2022.307129).

Development and design of a culturally tailored intervention to address COVID-19 disparities among Oregon's Latinx communities: A community case study.

Background: Latinx communities are disproportionately affected by COVID-19 compared with non-Latinx White communities in Oregon and much of the United States. The COVID-19 pandemic presents a critical and urgent need to reach Latinx communities with innovative, culturally tailored outreach and health promotion interventions to reduce viral transmission and address disparities. The aims of this case study are to (1) outline the collaborative development of a culturally and trauma-informed COVID-19 preventive intervention for Latinx communities; (2) describe essential intervention elements; and (3) summarize strengths and lessons learned for future applications. Methods: Between June 2020 and January 2021, a multidisciplinary team of researchers and Latinx-serving partners engaged in the following intervention development activities: a scientific literature review, a survey of 67 Latinx residents attending public testing events, interviews with 13 leaders of community-based organizations serving Latinx residents, and bi-weekly consultations with the project's Public Health and Community Services Team and a regional Community and Scientific Advisory Board. After launching the intervention in the field in February 2021, bi-weekly meetings with interventionists continuously informed minor iterative refinements through present day. Results: The resulting intervention, Promotores de Salud, includes outreach and brief health education. Bilingual, trauma-informed trainings and materials reflect the lived experiences, cultural values, needs, and concerns of Latinx communities. Interventionists (21 Promotores) were Latinx residents from nine Oregon counties where the intervention was delivered. Conclusions: Sharing development and intervention details with public health researchers and practitioners facilitates intervention uptake and replication to optimize the public health effect in Oregon's Latinx communities and beyond.

Effectiveness of a COVID-19 Testing Outreach Intervention for Latinx Communities: A Cluster Randomized Trial.

Importance: Latinx individuals have been disproportionately affected during the COVID-19 pandemic caused by the spread of SARS-CoV-2. It is imperative to evaluate newly developed preventive interventions to assess their effect on COVID-19 health disparities. Objective: To examine the effectiveness of a culturally tailored outreach intervention designed to increase SARS-CoV-2 testing rates among Latinx populations. Design, Setting, and Participants: In this cluster randomized trial performed from February 1 to August 31, 2021, in community settings in 9 Oregon counties, 38 sites were randomized a priori (19 to the community health promoters intervention and 19 to outreach as usual wait-listed controls). Thirty-three sites were activated. A total of 394 SARS-CoV-2 testing events were held and 1851 diagnostic samples collected, of which 919 were from Latinx persons. Interventions: A culturally informed outreach program was developed that made use of promotores de salud (community health promoters) to increase Latinx SARS-CoV-2 testing. Strategies addressed barriers by disseminating information on testing events in English and Spanish, mitigating misinformation, and increasing trust. Main Outcomes and Measures: The primary outcomes were the count of sample tests from Latinx persons and the sampled proportion of the Latinx populace. Site-level covariates included census tract Latinx populace, nativity (number of US-born individuals per 100 population), median age, and income inequality. Time-varying covariates included number of new weekly SARS-CoV-2-positive cases and percentage of vaccine coverage at the county level. Results: A total of 15 clusters (sites) were randomized to the control group and 18 to the community health promoters group. A total of 1851 test samples were collected, of which 995 (53.8%) were from female participants and 919 (49.6%) were from Latinx individuals. The intervention tested 3.84 (95% CI, 2.47-5.97) times more Latinx individuals per event than controls (incident rate ratio, 0.79; 95% CI, 0.46-1.34; Cohen d = 0.74; P < .001). The intervention was associated with a 0.28 increase in the proportion of Latinx populace being tested compared with control sites for the dependent variable scaled as the proportion of the Latinx populace ×100, or a 0.003 proportion of the raw populace count. The use of a standardized scaling of the proportion of Latinx individuals showed that the relative percentage increase was 0.53 (95% CI, 0.21-0.86) in the intervention sites compared with controls, representing a medium effect size. Conclusions and Relevance: To our knowledge, this was the first randomized evaluation of an outreach intervention designed to increase SARS-CoV-2 testing among Latinx populations. Findings could be used to implement strategies to reduce other health disparities experienced by these groups. Trial Registration: ClinicalTrials.gov Identifier: NCT04793464.

COVID-19 vaccine deliberation among people who inject drugs.

Background: People who inject drugs (PWID) are at greater risk for severe morbidity and mortality associated with COVID-19 due to comorbid, chronic, medical conditions and structural inequities associated with housing instability and incarceration. As such, they are a population that would greatly benefit from COVID-19 vaccination. Methods: We surveyed 350 syringe exchange clients between March 2021 and June 2021 to collect information on vaccine uptake among PWID, facilitators and barriers to vaccination, and demographic correlates of vaccine hesitancy. Results: Findings highlight that among PWID, vaccination access was remarkably low with only 10% of the sample receiving a COVID-19 vaccine. Vaccine acceptability among people who were vaccinated was 42% highlighting barriers to access. Motivation for vaccination included a desire to keep family members and other community members safe and a desire to feel safe around other people. Barriers to vaccination included concerns about vaccine side effects, lack of concern surrounding the effects of COVID-19, and insufficient information about how the vaccine works, along with general distrust of the vaccine development and deployment process. Conclusions: There is a need for structural interventions and individual behavioral interventions to improve COVID-19 vaccine access and uptake among PWID. Limitations and implications for next steps and future directions are discussed.

Contingency Management and SARS-CoV-2 Testing Among People Who Inject Drugs.

OBJECTIVES: People who inject drugs (PWID) are especially vulnerable to morbidity and mortality as a result of SARS-CoV-2 infection because of social and physical health vulnerabilities. Routine testing for SARS-CoV-2 is critical to reduce transmission. Contingency management-the provision of tangible rewards to reinforce positive behavior-can promote the use of health services among PWID. Evidence is scarce on the utility of contingency management to promote SARS-CoV-2 testing. The objective of this study was to evaluate the effectiveness of contingency management to increase testing among PWID. METHODS: SARS-CoV-2 testing was implemented at 9 syringe exchange program sites in partnership with an Oregon-based nonprofit organization for 5 weeks without contingency management and for 6 weeks with contingency management (a $10 financial incentive for testing) from February 1 through mid-April 2021. We measured rates of testing among syringe exchange program clients before and after implementation of contingency management. RESULTS: Before contingency management, SARS-CoV-2 testing occurred during approximately 131 of 1410 (9.3%) client encounters, and 123 of 997 (12.3%) unique clients were tested. During contingency management, testing occurred during approximately 571 of 1756 (32.5%) client encounters, and 407 of 1151 (35.4%) unique clients were tested. Rates of testing increased from 0.04 (SD, 0.04) before contingency management implementation to 0.25 (SD, 0.15) after implementation (t8 = -3.88; P = .005; Cohen d = 1.46). CONCLUSIONS: Contingency management facilitated uptake of SARS-CoV-2 testing among PWID. Contingency management may be an effective strategy for improving communicable disease testing beyond testing for SARS-CoV-2 and for improving vaccine uptake among PWID and warrants additional research.

Implementation methodology from a social systems informatics and engineering perspective applied to a parenting training program.

OBJECTIVE: For implementation of an evidence-based program to be effective, efficient, and equitable across diverse populations, we propose that researchers adopt a systems approach that is often absent in efficacy studies. To this end, we describe how a computer-based monitoring system can support the delivery of the New Beginnings Program (NBP), a parent-focused evidence-based prevention program for divorcing parents. METHOD: We present NBP from a novel systems approach that incorporates social system informatics and engineering, both necessary when utilizing feedback loops, ubiquitous in implementation research and practice. Examples of two methodological challenges are presented: how to monitor implementation, and how to provide feedback by evaluating system-level changes due to implementation. RESULTS: We introduce and relate systems concepts to these two methodologic issues that are at the center of implementation methods. We explore how these system-level feedback loops address effectiveness, efficiency, and equity principles. These key principles are provided for designing an automated, low-burden, low-intrusive measurement system to aid fidelity monitoring and feedback that can be used in practice. DISCUSSION: As the COVID-19 pandemic now demands fewer face-to-face delivery systems, their replacement with more virtual systems for parent training interventions requires constructing new implementation measurement systems based on social system informatics approaches. These approaches include the automatic monitoring of quality and fidelity in parent training interventions. Finally, we present parallels of producing generalizable and local knowledge bridging systems science and engineering method. This comparison improves our understanding of system-level changes, facilitates a program's implementation, and produces knowledge for the field. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Health behaviour outcomes of a family based intervention for paediatric obesity in primary care: A randomized type II hybrid effectiveness-implementation trial.

BACKGROUND: Paediatric obesity is a multifaceted public health problem. Family based behavioural interventions are the recommended approach for the prevention of excess weight gain in children and adolescents, yet few have been tested under "real-world" conditions. OBJECTIVES: To evaluate the effectiveness of a family based intervention, delivered in coordination with paediatric primary care, on child and family health outcomes. METHODS: A sample of 240 families with racially and ethnically diverse (86% non-White) and predominantly low-income children (49% female) ages 6 to 12 years (M = 9.5 years) with body mass index (BMI) ≥85th percentile for age and gender were identified in paediatric primary care. Participants were randomized to either the Family Check-Up 4 Health (FCU4Health) program (N = 141) or usual care plus information (N = 99). FCU4Health, an assessment-driven individually tailored intervention designed to preempt excess weight gain by improving parenting skills was delivered for 6 months in clinic, at home and in the community. Child BMI and body fat were assessed using a bioelectrical impedance scale and caregiver-reported health behaviours (eg, diet, physical activity and family health routines) were obtained at baseline, 3, 6 and 12 months. RESULTS: Change in child BMI and percent body fat did not differ by group assignment. Path analysis indicated significant group differences in child health behaviours at 12 months, mediated by improved family health routines at 6 months. CONCLUSION: The FCU4Health, delivered in coordination with paediatric primary care, significantly impacted child and family health behaviours that are associated with the development and maintenance of paediatric obesity. BMI did not significantly differ.

Effects of the Family Check-Up 4 Health on Parenting and Child Behavioral Health: A Randomized Clinical Trial in Primary Care.

The Family Check-Up 4 Health (FCU4Health) is an adaptation of the Family Check-Up (FCU) for delivery in primary care settings. While maintaining the original FCU's focus on parenting and child behavioral health, we added content targeting health behaviors. This study evaluated whether the adapted FCU maintained positive effects on parenting (positive behavior support, limit setting, parental warmth) and child behavioral health (self-regulation, conduct problems, emotional problems). Pediatric (6-12 years) primary care patients with a BMI ≥ 85th%ile (n = 240) were recruited from primary care clinics in Phoenix. Children were 75% Latino, 49% female, and 73% Medicaid recipients. This type 2 effectiveness-implementation hybrid trial compared families randomized to FCU4Health (n = 141) or usual care (n = 99). FCU4Health was delivered over a period of 6 months. This study focuses on a priori secondary outcomes included parenting and child behavioral health targets of the original FCU, assessed at baseline and 3, 6, and 12 months. Significant improvements were found for the FCU4Health condition, compared to usual care, in parenting from baseline to the 3-month assessment [ß = .17 (.01; .32)]. Parenting predicted improvements in child self-regulation at 6-months [ß = .17 (.03; .30)], which in turn predicted reductions in conduct problems [ß = - .38 (- .51; - .23)] and emotional problems [ß = - .24 (- .38; - .09)] at 12 months. Ethnicity and language of delivery (English or Spanish) did not moderate these effects. The FCU4Health can improve parenting and child behavioral health outcomes when delivered in primary care.Trial Registration Trial registration number: NCT03013309 ClinicalTrials.gov.

What got in the way? Caregiver-reported challenges to home practice of assigned intervention skills.

Background: Evidence-based intervention (EBI) effectiveness is hindered by low rates of caregiver home practice, or caregiver rehearsal of intervention skills at home. Although home practice is essential to intervention success, we know little about what makes home practice difficult to complete. We sought to identify the challenges caregivers face when attempting home practice assignments within the context of community implementation of a family-based preventative EBI. We also aimed to identify barriers, perceived need, and implementation-related factors that may contribute to frequency of home practice challenges. Methods: The family-based preventative intervention Bridges was delivered to caregivers and adolescents in three public middle schools in North America within a randomized efficacy-effectiveness hybrid trial. Caregivers (N = 233) completed worksheets in which they reported challenges to home practice of intervention skills. Caregiver-endorsed challenges were coded for emergent themes and categorized into higher-order home practice challenge domains. Additional data was gathered through multiple methods. In addition to descriptive analyses, multilevel linear regressions were conducted to identify factors associated with frequency of home practice challenge domains. Results: Over 85% of caregivers reported one or more home practice challenges. Challenges fell into six domains: daily stresses, cognitions/beliefs about the intervention/practice, caregiver wellness/regulation, adolescent responsiveness, relevance/acceptability of intervention or assignment, and external barriers to practice. Adolescent externalizing symptoms, academic performance, and caregiver participation in the English-language intervention group (compared to Spanish-language delivery) were associated with greater frequency of reported challenges. Conclusions: Among caregivers already attending intervention sessions, specific support to overcome challenges in daily stresses and beliefs about the intervention/practice can support greater home practice compliance, which in turn may impact overall intervention effectiveness. Findings suggest that providing services in caregivers' preferred language may avert potential challenges. Further research into home practice challenges is necessary to identify appropriate home practice implementation supports. Plain Language Summary: Low rates and poor quality of caregiver home practice of intervention skills hampers intervention effectiveness, but no prior studies have identified the difficulties caregivers face when attempting home practice of intervention skills and their rates of occurrence. Within a community implementation of a family-based preventative intervention, we found that difficulties were common and largely fell in the domains theorized to impact engagement, such as daily stresses and beliefs about the intervention/practice. Findings also suggest that providing services and materials in caregivers' preferred language may avert potential home practice challenges. By identifying common home practice challenges and correlates of different challenges, our findings point to a need to develop appropriate and effective home practice implementation support.

Facilitators and Barriers in Cross-Country Transport of Evidence-based Preventive Interventions: a Case Study Using the Family Check-Up.

This study is a qualitative analysis of facilitators and barriers in the dissemination of Family Check-Up (FCU), a U.S.-developed preventive intervention in Sweden. The FCU is inherently culturally flexible because it was designed to be tailored to each family's needs and context, including cultural norms and values. We present the FCU implementation framework (IF) as a conceptual framework for cross-country transport of the FCU and evidence-based programs (EBP) more generally. The FCU IF draws from implementation science literature and involves specifying barriers and facilitators related to implementation drivers (e.g., competency) at each implementation phase and applying these data to inform phase-specific, readiness-building activities for each driver. In addition to driver-related influences, barriers and facilitators specific to the FCU and the collaborative partnership between the U.S. and Swedish purveyors emerged in the data. The partnership's reliance on a hybrid bottom-up, top-down approach that balanced the Swedish purveyor's autonomy and cultural expertise with guidance from the U.S. purveyor facilitated adaptation of the FCU for Sweden. Relying on previously collected data, we also explored similarities and differences in barriers and facilitators to FCU scale-up in the United States versus Sweden. In general, across drivers, the same barriers and facilitators were salient. This study suggests that dissemination of culturally flexible EBPs guided by a dynamic implementation framework can facilitate cross-country transport of EBPs. This study promotes a culture of prevention by highlighting barriers, facilitators, and readiness-building strategies that influence the cross-cultural transportability of EBPs that prevent the onset and escalation of child problem behavior.

Motivational Interviewing and Caregiver Engagement in the Family Check-Up 4 Health.

Motivational interviewing (MI) is a therapeutic style in which a provider elicits client motivation and helps strengthen commitment to change (Miller and Rollnick 2002). The original Family Check-Up (FCU; Dishion and Stormshak 2007)-and the adapted version for improving health behaviors in primary care, the Family Check-Up 4 Health (FCU4Health; Smith et al. 2018a)-are brief, assessment-driven, and family-centered preventive interventions that use MI to improve parent engagement in services to improve parenting and prevent negative child outcomes. This study examines the role of MI in the Raising Healthy Children project, a randomized trial to test the effectiveness of the FCU4Health for the prevention of obesity in pediatric primary care, with data from the 141 families assigned to receive the FCU4Health. Families were eligible for the study if the child was between 5.5 and 12 years of age at the time of identification and had a BMI ≥ 85th percentile for age and gender at the most recent visit to their primary care provider. MI skills at the first session predicted caregiver in-session active engagement, attendance at follow-up parenting sessions, and improvements in motivation to address child health and behavior goals. Baseline characteristics of the family (i.e., child health diagnosis, caregiver baseline depression, motivation, and Spanish language preference) had differential associations with responsiveness and MI skills. This study has implications for program development, provider training, and fidelity monitoring.

The Family Check-Up 4 Health: Study protocol of a randomized type II hybrid effectiveness-implementation trial in integrated primary care (the healthy communities 4 healthy students study).

BACKGROUND: Parenting interventions like the Family Check-Up have demonstrated effects on child physical and behavioral health outcomes. However, access to these programs is limited, particularly for populations experiencing health disparities. Primary care settings have become recognized as a potential delivery system in which these programs may be implemented at scale. The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting. METHODS: We will conduct a hybrid type 2 effectiveness-implementation trial in partnership with a primary care clinic in a low-income, majority Latino community. Families with 2- to 5-year-old children will be eligible to participate. Families will be randomized to receive the intervention (n = 130) or services as usual (n = 70) and will be assessed annually over three years. Outcomes are informed by the RE-AIM framework (i.e., reach, effectiveness, adoption, implementation, and maintenance). Effectiveness outcomes include child health behaviors (e.g., Dietary Screener Questionnaire), behavioral health (e.g., Strengths and Difficulties Questionnaire), and parenting (e.g., Proactive Parenting). Early stage implementation outcomes are also included (e.g., cost, acceptability, appropriateness, and feasibility). Effectiveness outcomes will be assessed via intent-to-treat (ITT) analyses. Implementation outcomes will be primarily descriptive with comparisons to prior trials of FCU4Health and the original FCU. PROJECTED OUTCOMES: This trial will provide evidence related to the potential of integrated primary care settings to deliver evidence-based preventive interventions with a dual focus on behavioral and physical health.

Provider Readiness and Adaptations of Competency Drivers During Scale-Up of the Family Check-Up.

We used provider (n = 112) data that staff at the agency disseminating the Family Check-Up (FCU; REACH Institute) collected to profile provider diversity in community settings and to examine whether provider profiles are related to implementation fidelity. Prior to FCU training, REACH Institute staff administered the FCU Provider Readiness Assessment (PRA), a provider self-report measure that assesses provider characteristics previously linked with provider uptake of evidence-based interventions. We conducted a latent class analysis using PRA subscale scores as latent class indicators. Results supported four profiles: experienced high readiness (ExHR), experienced low readiness (ExLR), moderate experience (ME), and novice. The ExHR class was higher than all other classes on: (1) personality variables (i.e., agreeableness, conscientiousness, openness, extraversion); (2) evidence-based practice attitudes; (3) work-related enthusiasm and engagement; and (4) their own well-being. The ExHR class was also higher than ExLR and ME classes on clinical flexibility. The ME class was lowest of all classes on conscientiousness, supervision, clinical flexibility, work-related enthusiasm and engagement, and well-being. During the FCU certification process, FCU Consultants rated providers' fidelity to the model. Twenty-three of the 112 providers that completed the PRA also participated in certification. We conducted follow-up regression analyses using fidelity data for these 23 providers to explore associations between probability of class membership and fidelity. The likelihood of being in the ExHR class was related to higher FCU fidelity, whereas the likelihood of being in the ExLR class was related to lower fidelity. We discuss how provider readiness assessment data can be used to guide the adaptation of provider selection, training, and consultation in community settings.

Redesigning Implementation Measurement for Monitoring and Quality Improvement in Community Delivery Settings.

The field of prevention has established the potential to promote child adjustment across a wide array of outcomes. However, when evidence-based prevention programs have been delivered at scale in community settings, declines in implementation and outcomes have resulted. Maintaining high quality implementation is a critical challenge for the field. We describe steps towards the development of a practical system to monitor and support the high-quality implementation of evidence-based prevention programs in community settings. Research on the implementation of an evidence-based parenting program for divorcing families called the "New Beginnings Program" serves as an illustration of the promise of such a system. As a first step, we describe a multidimensional theoretical model of implementation that links aspects of program delivery with improvements in participant outcomes. We then describe research on the measurement of each of these implementation dimensions and test their relations to intended program outcomes. As a third step, we develop approaches to the assessment of these implementation constructs that are feasible to use in community settings and to establish their reliability and validity. We focus on the application of machine learning algorithms and web-based data collection systems to assess implementation and provide support for high quality delivery and positive outcomes. Examples are presented to demonstrate that valid and reliable measures can be collected using these methods. Finally, we envision how these measures can be used to develop an unobtrusive system to monitor implementation and provide feedback and support in real time to maintain high quality implementation and program outcomes.

The Family Check-Up 4 Health (FCU4Health): Applying Implementation Science Frameworks to the Process of Adapting an Evidence-Based Parenting Program for Prevention of Pediatric Obesity and Excess Weight Gain in Primary Care.

Implementation experts have recently argued for a process of "scaling out" evidence-based interventions, programs, and practices (EBPs) to improve reach to new populations and new service delivery systems. A process of planned adaptation is typically required to integrate EBPs into new service delivery systems and address the needs of targeted populations while simultaneously maintaining fidelity to core components. This process-oriented paper describes the application of an implementation science framework and coding system to the adaptation of the Family Check-Up (FCU), for a new clinical target and service delivery system-prevention of obesity and excess weight game in primary care. The original FCU has demonstrated both short- and long-term effects on obesity with underserved families across a wide age range. The advantage of adapting such a program is the existing empirical evidence that the intervention improves the primary mediator of effects on the new target outcome. We offer a guide for determining the levels of evidence to undertake the adaptation of an existing EBP for a new clinical target. In this paper, adaptation included shifting the frame of the intervention from one of risk reduction to health promotion; adding health-specific assessments in the areas of nutrition, physical activity, sleep, and media parenting behaviors; family interaction tasks related to goals for health and health behaviors; and coordinating with community resources for physical health. We discuss the multi-year process of adaptation that began by engaging the FCU developer, community stakeholders, and families, which was then followed by a pilot feasibility study, and continues in an ongoing randomized effectiveness-implementation hybrid trial. The adapted program is called the Family Check-Up 4 Health (FCU4Health). We apply a comprehensive coding system for the adaptation of EBPs to our process and also provide a side-by-side comparison of behavior change techniques for obesity prevention and management used in the original FCU and in the FCU4Health. These provide a rigorous means of classification as well as a common language that can be used when adapting other EBPs for context, content, population, or clinical target. Limitations of such an approach to adaptation and future directions of this work are discussed.

Ethical Challenges in Promoting the Implementation of Preventive Interventions: Report of the SPR Task Force.

Prevention science researchers and practitioners are increasingly engaged in a wide range of activities and roles to promote evidence-based prevention practices in the community. Ethical concerns invariably arise in these activities and roles that may not be explicitly addressed by university or professional guidelines for ethical conduct. In 2015, the Society for Prevention Research (SPR) Board of Directors commissioned Irwin Sandler and Tom Dishion to organize a series of roundtables and establish a task force to identify salient ethical issues encountered by prevention scientists and community-based practitioners as they collaborate to implement evidence-based prevention practices. This article documents the process and findings of the SPR Ethics Task Force and aims to inform continued efforts to articulate ethical practice. Specifically, the SPR membership and task force identified prevention activities that commonly stemmed from implementation and scale-up efforts. This article presents examples that illustrate typical ethical dilemmas. We present principles and concepts that can be used to frame the discussion of ethical concerns that may be encountered in implementation and scale-up efforts. We summarize value statements that stemmed from our discussion. We also conclude that the field of prevention science in general would benefit from standards and guidelines to promote ethical behavior and social justice in the process of implementing evidence-based prevention practices in community settings. It is our hope that this article serves as an educational resource for students, investigators, and Human Subjects Review Board members regarding some of the complexity of issues of fairness, equality, diversity, and personal rights for implementation of preventive interventions.

Effect of Middle School Interventions on Alcohol Misuse and Abuse in Mexican American High School Adolescents: Five-Year Follow-up of a Randomized Clinical Trial.

Importance: Substance abuse preventive interventions frequently target middle school students and demonstrate efficacy to prevent early onset and use of alcohol and illicit drugs. However, evidence of sustained results to prevent later patterns of alcohol misuse and more serious alcohol abuse disorders has been lacking, particularly for US Latino populations. Objective: To test whether a universal middle school prevention program can reduce the frequency of alcohol misuse and rates of alcohol use disorder 5 years after implementation with a Mexican American sample. Design, Setting, and Participants: A previous randomized clinical trial was conducted with 516 Mexican American 7th graders and at least 1 parent who identified as having Mexican origin. Three annual cohorts of families were recruited from rosters of 4 middle schools and randomized to the 9-session Bridges/Puentes family-focused group intervention or a workshop control condition. Recruitment, screening, pretest, and randomization occurred in the same academic year for each cohort: 2003-2004, 2004-2005, and 2005-2006. Data acquisition for the follow-up assessments of late-adolescent alcohol misuse and abuse, which were not included in the initial randomized clinical trial, was conducted from September 2009 to September 2014; analysis was conducted between August 2016 and July 2017. In this assessment, 420 children (81.4%) of the sample were included, when the majority were in their final year of high school. Interventions: The 9-session Bridges/Puentes intervention integrated youth, parent, and family intervention sessions that were delivered in the spring semester at each school, with separate groups for English-dominant vs Spanish-dominant families. The control workshop was offered during the same semester at each school, also in English and Spanish. Main Outcomes and Measures: Primary outcomes were diagnostic assessment of lifetime alcohol use disorder in the 12th grade, 5 years after the intervention, based on the Diagnostic Interview Schedule for Children and past-year frequency of alcohol use, binge drinking, and drunkenness based on the 2001 Youth Risk Behavior Survey. Results: Of the 420 participants, 215 (51.2%) were girls (mean [SD] age, 17.9 [0.62] years). The intervention reduced the likelihood of having an alcohol use disorder (ß = -.93; SE, 0.47; P = .047; odds ratio, 0.39). Intervention associations with past-year alcohol use frequency, binge drinking, and drunkenness were moderated by baseline substance use. The intervention reduced the frequency of alcohol use (ß = -.51; SE, 0.24; P = .04; Cohen d = 0.43) and drunkenness (ß = -.51; SE, 0.26; P = .049; Cohen d = 0.41) among youth who reported any previous substance use at baseline (T1 initiators) but not among those who had not initiated any substance use (T1 abstainers) at baseline. For past-year binge drinking, the intervention finding did not reach statistical significance among T1 initiators (ß = -.40; SE, 0.23; P = .09) or T1 abstainers (ß = .23; SE, 0.14; P = .11). Conclusions and Relevance: Study results support an association between a universal middle school intervention and alcohol misuse and alcohol use disorders among Mexican American high school students and implementation of universal middle school interventions to reach Latino communities.

An individually tailored family-centered intervention for pediatric obesity in primary care: study protocol of a randomized type II hybrid effectiveness-implementation trial (Raising Healthy Children study).

BACKGROUND: Pediatric obesity is a multi-faceted public health concern that can lead to cardiovascular diseases, cancers, and early mortality. Small changes in diet, physical activity, or BMI can significantly reduce the possibility of developing cardiometabolic risk factors. Family-based behavioral interventions are an underutilized, evidence-based approach that have been found to significantly prevent excess weight gain and obesity in children and adolescents. Poor program availability, low participation rates, and non-adherence are noted barriers to positive outcomes. Effective interventions for pediatric obesity in primary care are hampered by low family functioning, motivation, and adherence to recommendations. METHODS: This (type II) hybrid effectiveness-implementation randomized trial tests the Family Check-Up 4 Health (FCU4Health) program, which was designed to target health behavior change in children by improving family management practices and parenting skills, with the goal of preventing obesity and excess weight gain. The FCU4Health is assessment driven to tailor services and increase parent motivation. A sample of 350 families with children aged 6 to 12 years who are identified as overweight or obese (BMI ≥ 85th percentile for age and gender) will be enrolled at three primary care clinics [two Federally Qualified Healthcare Centers (FQHCs) and a children's hospital]. All clinics serve predominantly Medicaid patients and a large ethnic minority population, including Latinos, African Americans, and American Indians who face disparities in obesity, cardiometabolic risk, and access to care. The FCU4Health will be coordinated with usual care, using two different delivery strategies: an embedded approach for the two FQHCs and a referral model for the hospital-based clinic. To assess program effectiveness (BMI, body composition, child health behaviors, parenting, and utilization of support services) and implementation outcomes (such outcomes as acceptability, adoption, feasibility, appropriateness, fidelity, and cost), we use a multi-method and multi-informant assessment strategy including electronic health record data, behavioral observation, questionnaires, interviews, and cost capture methods. DISCUSSION: This study has the potential to prevent excess weight gain, obesity, and health disparities in children by establishing the effectiveness of the FCU4Health and collecting information critical for healthcare decision makers to support sustainable implementation of family-based programs in primary care. TRIAL REGISTRATION: NCT03013309 ClinicalTrials.gov.

"Home Practice Is the Program": Parents' Practice of Program Skills as Predictors of Outcomes in the New Beginnings Program Effectiveness Trial.

An examination of the content and processes of evidence-based programs is critical for empirically evaluating theories about how programs work, the "action theory" of the program (West et al. in American Journal of Community Psychology, 21, 571-605, 1993). The New Beginnings Program (NBP; Wolchik et al., 2007), a parenting-after-divorce preventive intervention, theorizes that program-induced improvements in parenting across three domains: positive relationship quality, effective discipline, and protecting children from interparental conflict, will reduce the negative outcomes that are common among children from divorced families. The process theory is that home practice of program skills related to these parenting domains is the primary mechanism leading to positive change in parenting. This theory was tested using multi-rater data from 477 parents in the intervention condition of an effectiveness trial of the NBP (Sandler et al. 2016a, 2016b). Four research questions were addressed: Does home practice of skills predict change in the associated parenting outcomes targeted by the program? Is the effect above and beyond the influence of attendance at program sessions? What indicators of home practice (i.e., attempts, fidelity, efficacy, and competence) are most predictive of improvements in parenting? Do these indicators predict parenting improvements in underserved subpopulations (i.e., fathers and Latinos)? Structural Equation Modeling analyses indicated that parent-reported efficacy and provider-rated parent competence of home practice predicted improvements in the targeted parenting domains according to both parent and child reports. Moreover, indicators of home practice predicted improvements in parenting for fathers and Latinos, although patterns of effects varied by parenting outcome.