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Power analysis informs a priori planning of behavioral and medical research, including for randomized clinical trials that are nomothetic (i.e., studies designed to infer results to the general population based on inter individual variabilities). Far fewer investigations and resources are available for power analysis of clinical trials that follow an idiographic approach, which emphasizes intra individual variabilities between baseline (control) phase versus one or more treatment phases. We tested the impact on statistical power to detect treatment outcomes of four idiographic trial design factors that are under researchers’ control, assuming a multiple baseline design: sample size, number of observations per participant, proportion of observations in the baseline phase, and competing statistical models (i.e., hierarchical modeling versus piecewise regression). We also tested the impact of four factors that are largely outside of researchers’ control: population size, proportion of intraindividual variability due to residual error, treatment effect size, and form of outcomes during the treatment phase (phase jump versus gradual change). Monte Carlo simulations using all combinations of the factors were sampled with replacement from finite populations of 200, 1750, and 3500 participants. Analyses characterized the unique relative impact of each factor individually and all two-factor combinations, holding all others constant. Each factor impacted power, with the greatest impact being from larger treatment effect sizes, followed respectively by more observations per participant, larger samples, less residual variance, and the unexpected improvement in power associated with assigning closer to 50% of observations to the baseline phase. This study’s techniques and R package better enable a priori rigorous design of idiographic clinical trials for rare diseases, precision medicine, and other small-sample studies.

No known studies have investigated co-occurrence of psychopathology problems in adolescents with biologic and/or environmental susceptibility, including prenatal drug exposure. This study identified comorbidity patterns of psychopathology problems by utilizing data from urban, primarily African American, youth, majority of whom were at heightened risk for exposure to drugs in utero. The roles of Research Domain Criteria (RDoC)-informed behavioral constructs of the Negative Valence (irritability) and Social Process Systems (social disinhibition) as antecedents of the comorbidity patterns were further examined. Lastly, the predictive validity of the identified patterns was evaluated in relation to emerging adulthood outcomes. Participants were 358 urban adolescents, primarily African Americans, drawn from a 21-year prospective birth-cohort study of the effects of prenatal drug exposure. Psychopathology problems were assessed at age 15. Irritability and social disinhibition were self-reported at age 12. Emerging adulthood outcomes were measured at age 21. Latent class modeling indicated four patterns: Normative (57%), substance-use (SU; 24%), mental-health-problems-without-substance-use (MH; 11%), and substance-use-and-other-mental-health-problems (SUMH; 7%). Higher irritability increased the odds of developing the MH pattern, whereas higher social disinhibition increased the odds of developing the SU pattern. The odds of manifesting the SUMH pattern were higher for children with higher irritability. For children with higher social disinhibition, the odds of manifesting the SUMH pattern were higher at a trend level. Adolescent comorbidity patterns were differentially associated with problematic tobacco and marijuana use and clinically relevant mental health problems in emerging adulthood, and completion of high school education. Peri-pubertal identification of individual differences in irritability and social disinhibition may mitigate the emergence of adolescent psychopathology, which could influence emerging adulthood adjustment in this at-risk population.

Community violence is a persistent and challenging public health problem. Community violence not only physically affects individuals, but also its effects reverberate to the well-being of families and entire communities. Being exposed to and experiencing violence are adverse community experiences that affect the well-being and health trajectories of both children and adults. In the United States, community violence has historically been addressed through a lens of law enforcement and policing; the impact of this approach on communities has been detrimental and often ignores the strengths and experiences of community members. As such, community-centered approaches to address violence are needed, yet the process to design, implement, and evaluate these approaches is complex. Alternatives to policing responses are increasingly being implemented. However, evidence and implementation guidance for community-level public health approaches remain limited. This study protocol seeks to address community violence through a resilience framework-Adverse Community Experiences and Resilience (ACE|R)-being implemented in a major US city and leveraging a strategy of community organizing to advance community violence prevention. The objective of this research is to understand the impact of community-level violence prevention interventions. Furthermore, we aim to describe the strategies of implementation and identify barriers to and facilitators of the approach. This study uses a hybrid type 1 effectiveness-implementation design. Part 1 of the study will assess the effectiveness of the ACE|R framework plus community organizing by measuring impacts on violence- and health-related outcomes. To do so, we plan to collect quantitative data on homicides, fatal and nonfatal shootings, hospital visits due to nonaccidental injuries, calls for service, and other violence-related data. In Part 2 of the study, to assess the implementation of ACE|R plus community organizing, we will collect process data on community engagement events, deliver community trainings on community leadership and organizing, and conduct focus groups with key partners about violence and violence prevention programs in Milwaukee. This project received funding on September 1, 2020. Prospective study data collection began in the fall of 2021 and will continue through the end of 2023. Data analysis is currently underway, and the first results are expected to be submitted for publication in 2024. Community violence is a public health problem in need of community-centered solutions. Interventions that center community and leverage community organizing show promise in decreasing violence and increasing the well-being of community members. Methods to identify the impact of community-level interventions continue to evolve. Analysis of outcomes beyond violence-specific outcomes, including norms and community beliefs, may help better inform the short-term and proximal impacts of these community-driven approaches. Furthermore, hybrid implementation-effectiveness trials allow for the inevitable contextualization required to disseminate community interventions where communities drive the adaptations and decision-making. DERR1-10.2196/50444.

There has been relatively little research on effects of interventions aimed directly at improving internal community coalition functioning, particularly in the area of planning for adoption of evidence-based prevention programs. The current study investigated the effect of Project STEP, a prevention diffusion trial, on three factors hypothesized to improve coalition prevention planning (quality of coalition plans, extent of plan implementation, and committee internal functioning in meetings). Cities were randomly assigned to one of three conditions (televised training with limited technical assistance, televised training alone, or control; n = 24). Results demonstrated that at 1.5 year follow-up, coalitions in the two intervention groups showed more effective prevention plans, plan implementation, and functioning in meetings than control coalitions. Group differences were maintained at 3-year follow-up, albeit at decreased levels, for quality of planning and implementation. The findings suggest that building coalition capacity to diffuse evidence-based prevention programs works at least partially by increasing the effectiveness of coalition functioning, and that booster training may be warranted within 3 years after initial training. [PUBLICATION ABSTRACT]

Youth who suffer from psychiatric disorders are at high risk for negative outcomes, including aggression and substance abuse. Although many youth with psychiatric disorders have endured harsh parenting and/or child maltreatment (CM), differential associations between these experiential factors have yet to be fully explored. Sleep problems have also been implicated in psychiatric disorders and are consistently associated with CM. The overlap and unique contributions of CM and sleep problems to the mental health of youth remains unclear; longitudinal studies from late childhood into adolescence, when psychiatric illnesses frequently onset, are rare. The current longitudinal study examined associations of CM, harsh parenting, and sleep problems with symptoms of four psychiatric disorders: Conduct Disorder, Attention Deficit Hyperactivity Disorder, Anxiety, and Depression. Early adolescent youth with no history of substance use (N = 529) were sampled from a working class, medium-sized city in northern Kentucky, and an extensive battery of tests were administered to youth and a parent. CM was more strongly and consistently related to psychiatric disorder symptoms at baseline than was harsh parenting. Reports of harsh parenting were more strongly associated with externalizing symptoms than internalizing symptoms. Sleep problems were also positively associated with psychiatric disorder symptoms at baseline, but did not exacerbate the effects of CM or harsh parenting on symptom counts. Longitudinally, harsh parenting was more predictive of change in psychiatric symptoms two to three years later than was CM. The potential significance of childhood adversity and sleep problems for prevention of later mental health problems are discussed.

Despite growing evidence and support for co-locating behavioral services in primary care to prevent risky health behaviors, implementation of these services has been limited due to a lack of reimbursement for services and negative perceptions among providers. We investigated potential to overcome these barriers based on new developments in healthcare funding and screening and referral to prevention (SRP) in primary care based on the Consolidated Framework for Implementation Research (CFIR), which could guide future SRP implementation strategies. To investigate the economic need for healthcare-based SRP, we quantified hospital charges to healthcare payors for services arising from adolescent risky behaviors (e.g., substance use, risky sex). Annual North Carolina (NC) hospital charges for these services exceeded $327 M (2019 dollars), suggesting high potential for cost savings if SRP can curb hospital services associated with risky behaviors. To investigate provider barriers and facilitators, we surveyed 151 NC pediatricians and 230 NC family therapists about their attitudes regarding a recently developed well-child visit SRP with family-based prevention. Both sets of professionals reported widespread need for and interest in the SRP but cited barriers of lack of reimbursement, training, and referrals to/from each other. Physicians, but not family therapists, reported concerns with poor patient or parent compliance. Many barriers could be resolved by co-locating family therapists in pediatric clinics to conduct well-child SRP. Our results support further research to develop business models for payor-funded SRP and CFIR-guided research to develop implementation strategies for primary care SRP to prevent adolescent risky health behaviors.

This supplemental issue describes the individual studies and collaborative efforts of the Helping to End Addiction Long-term Prevention Cooperative’s (HPC’s) innovative approaches to rapidly develop evidence-based prevention programs for widespread dissemination. This introduction succinctly reviews (1) the context that demands the rapid development of efficacious prevention programs and their scale-ups, (2) the unique objectives of the individual HPC research projects, and (3) collective efforts to harmonize research across studies to advance the prevention of opioid misuse and gain insight into opioid misuse etiology to inform improvements in preventive interventions. At the conclusion of HPC studies, we anticipate the availability of multiple evidence-based programs to prevent opioid misuse and use disorder for persons who experience particular sources of risk and for delivery in settings where prevention has traditionally been lacking. By harmonizing and coordinating efforts across 10 distinct outcomes studies of prevention programs and making data available for analysis by non-HPC researchers, the HPC’s efficacy and etiology evidence will far surpass the additive contributions of 10 individual research projects.

A broad-span, six-stage translational prevention model is presented, extending from the basic sciences—taking a multi-level systems approach, including the neurobiological sciences—through to globalization. The application of a very wide perspective of translation research from basic scientific discovery to international policy change promises to elicit sustainable, populationlevel reductions in behavioral health disorders. To illustrate the conceptualization and actualization of a program of translational prevention research, we walk through each stage of research to practice and policy using an exemplar, callous-unemotional (CU) traits. Basic science has identified neurobiological, psychophysiological, behavioral, contextual, and experiential differences in this subgroup, and yet, these findings have not been applied to the development of more targeted intervention. As a result, there are currently no programs considered especially effective for CU traits, likely because they do not specifically target underlying mechanisms. To prevent/reduce the prevalence of conduct disorder, it is critical that we transfer existing knowledge to subsequent translational stages, including intervention development, implementation, and scaling. And eventually, once resulting programs have been rigorously evaluated, replicated, and adapted across cultural, ethnic, and gender groups, there is potential to institutionalize them as well as call attention to the special needs of this population. In this paper, we begin to consider what resources and changes in research perspectives are needed to move along this translational spectrum.

We aim to review the association between childhood-onset mental health conditions and increased risk for early substance use including opioid misuse and opioid use disorders (OUD). The association between mental health conditions and opioid misuse suggests youth with mental health conditions may benefit from opioid prevention efforts that concurrently address mental health. To aid in the identification of youth with mental health conditions who could benefit from interventions, we will review opportunities and challenges associated with screening for mental health symptoms or substance use in settings where youth at high risk for mental health conditions present. We will also review how research projects within the National Institutes of Health’s Helping to End Addiction Long-term (HEAL) Prevention Cooperative are addressing mental health within opioid misuse and OUD prevention interventions for youth.

The Helping to End Addiction Long-Term (HEAL) Prevention Cooperative (HPC) is rapidly developing 10 distinct evidence-based interventions for implementation in a variety of settings to prevent opioid misuse and opioid use disorder. One HPC objective is to compare intervention impacts on opioid misuse initiation, escalation, severity, and disorder and identify whether any HPC interventions are more effective than others for types of individuals. It provides a rare opportunity to prospectively harmonize measures across distinct outcomes studies. This paper describes the needs, opportunities, strategies, and processes that were used to harmonize HPC data. They are illustrated with a strategy to measure opioid use that spans the spectrum of opioid use experiences (termed involvement) and is composed of common “anchor items” ranging from initiation to symptoms of opioid use disorder. The limitations and opportunities anticipated from this approach to data harmonization are reviewed. Lastly, implications for future research cooperatives and the broader HEAL data ecosystem are discussed.