Intervention Optimization: A Paradigm Shift and Its Potential Implications for Clinical Psychology.

To build a coherent knowledge base about what psychological intervention strategies work, develop interventions that have positive societal impact, and maintain and increase this impact over time, it is necessary to replace the classical treatment package research paradigm. The multiphase optimization strategy (MOST) is an alternative paradigm that integrates ideas from behavioral science, engineering, implementation science, economics, and decision science. MOST enables optimization of interventions to strategically balance effectiveness, affordability, scalability, and efficiency. In this review we provide an overview of MOST, discuss several experimental designs that can be used in intervention optimization, consider how the investigator can use experimental results to select components for inclusion in the optimized intervention, discuss the application of MOST in implementation science, and list future issues in this rapidly evolving field. We highlight the feasibility of adopting this new research paradigm as well as its potential to hasten the progress of psychological intervention science. Expected final online publication date for the Annual Review of Clinical Psychology, Volume 20 is May 2024. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

Operationalizing Primary Outcomes to Achieve Reach, Effectiveness, and Equity in Multilevel Interventions.

When intervention scientists plan a clinical trial of an intervention, they select an outcome metric that operationalizes their definition of intervention success. The outcome metric that is selected has important implications for which interventions are eventually supported for implementation at scale and, therefore, what health benefits (including how much benefit and for whom) are experienced in a population. Particularly when an intervention is to be implemented in a population that experiences a health disparity, the outcome metric that is selected can also have implications for equity. Some outcome metrics risk exacerbating an existing health disparity, while others may decrease disparities for some but have less effect for the larger population. In this study, we use a computer to simulate implementation of a hypothetical multilevel, multicomponent intervention to highlight the tradeoffs that can occur between outcome metrics that reflect different operationalizations of intervention success. In particular, we highlight tradeoffs between overall mean population benefit and the distribution of health benefits in the population, which has direct implications for equity. We suggest that simulations like the one we present can be useful in the planning of a clinical trial for a multilevel and/or multicomponent intervention, since simulated implementation at scale can illustrate potential consequences of candidate operationalization of intervention success, such that unintended consequences for equity can be avoided.

Applying an Implementation Framework to the Dissemination of a School-Based Child Sexual Abuse Prevention Program.

Since the 1980s, school-based child sexual abuse (CSA) prevention programs have been the prevailing prevention strategy in the United States. Despite demonstrated effectiveness, there is a lack of infrastructure and educational policy ensuring all students receive these programs. A pragmatic application of the RE-AIM implementation framework, this study provides an overview of a multi-county implementation effort of the school-based CSA prevention program, Safe Touches. Implementation efforts across five counties in a Mid-Atlantic state are described at three levels: organizational (school districts), child, and program facilitator. Children's CSA-related knowledge was measured at four time points: pre-workshop, immediately post-workshop, and then 6 and 12 months post-workshop. Facilitators completed an anonymous survey post-implementation. Over the course of one and a half academic years, Safe Touches was implemented in 718 public school districts, reaching in total 14,235 second-grade students. Students' significantly increased knowledge from pre- to post-workshop and gains were maintained at 6 and 12 months (ps <.001). A total of 29 disclosures of maltreatment were made by students to facilitators during or after the workshop. Facilitators generally adopted Safe Touches and attested to the feasibility and benefits of its large-scale implementation as well as the negligible negative impacts for children. When implemented systematically, school-based CSA prevention is able to reach a high number of students, effectively increase CSA-related knowledge, and facilitates disclosures. To maximize the potential public health impact, it is suggested that state funds be allocated to support the implementation of such programs as part of standard education costs.

Preventive Education Outreach on Social Media: The Quest to Enroll Community Members in a Child Sexual Prevention Workshop.

Social media is a frequently used tool in health promotion efforts although less so for the prevention of child sexual abuse (CSA). This is due, in part, to the lack of standardized branding guides for community-based efforts in how to craft messages related to CSA prevention. This study examined the use of Twitter (now "X") as a means of promoting participation in the adult-focused Stewards of Children CSA prevention workshop, prior to and following the implementation of a standardized branding guide. The exposure, reach, and engagement of the top tweets and top media tweets were examined over 24-months pre- and post-implementation of a five-point branding guide. Engagement was descriptively compared to the number of adults who enrolled in the Stewards of Children workshop. As evidenced by the increase in tweet impressions and the number of adults trained, it is likely the implementation of the branding guide was beneficial in promoting participation in the Stewards of Children workshop. Though participation in a program does not inherently suggest behavior change, getting participants to enroll is a crucial first step. The findings emphasize the potential of using social media to ultimately promote behavior change in the field of CSA prevention and beyond.

Knowledge Gains from the Implementation of a Child Sexual Abuse Prevention Program and the Future of School-Based Prevention Education.

School-based child sexual abuse (CSA) programs effectively increase students' CSA-related knowledge. This study focuses on an implementation trial of Safe Touches, an empirically supported, school-based CSA prevention program, that was disrupted by the COVID-19 pandemic. We sought to demonstrate gains in CSA-related knowledge following Safe Touches but were limited to a pre-post design. A total of 2,210 students across five counties in a Mid-Atlantic state received the Safe Touches workshop between September 2019 and March 2020. McNemar's chi-square test was used to assess changes in the proportion of correct responses pre-workshop (Time 1) and one-week post-workshop (Time 2). Students' CSA-related knowledge increased significantly based on changes in mean CSA knowledge scores and the number of correct item-level responses assessed at Time 1 and Time 2 (p < .000). Leveraging the experience of the facilitators' who delivered these workshops prior to the disruption of implementation, we gathered facilitators' perspectives to explore the viability of offering Safe Touches virtually. In July 2020, 16 facilitators completed an electronic survey designed to understand the viability of a virtual Safe Touches workshop. Three themes emerged from facilitator feedback on virtual programming: student engagement concerns, handling disclosures, and technology access to a virtual program. The findings of this study indicate that the Safe Touches workshop significantly increased CSA-related knowledge and, overall, facilitators supported further exploration and development of a virtual Safe Touches workshop. The transition of empirically supported school-based CSA prevention programs to a virtual delivery modality is necessary to maintain an effective means of primary prevention and opportunity for disclosure.

Taking a School-Based Child Sexual Abuse Prevention Program to Scale: a Cost Analysis.

Cost analyses are used to determine overall costs of implementing evidence-based programming and may help decision makers determine how best to allocate finite resources. Child sexual abuse (CSA), regularly viewed as a human rights violation, is also a public health concern estimated to impact 27% of females and 5% of males by age 18. Universal, school-based CSA programs are one prevailing prevention strategy. However, there are no known cost analyses of school-based CSA prevention programming, thereby limiting potential scalability. Using the ingredients method, this cost analysis presents the findings of implementing Safe Touches, an evidence-based universal prevention program, across four sites (i.e., counties) in one mid-Atlantic state. Reaching a total of 14,235 s grade students, results indicate an average cost of $43 per student, an average classroom cost of $859, an average district cost of $10,637, and an average site cost of $154,243. There was a noted decrease in costs when more students were reached, suggesting a need to focus efforts on bolstering the reach of implementation efforts. Sensitivity analyses explored variations in implementation constraints such as personnel and facilities suggesting a range of per-student costs (lower-bound per-student cost = $34; upper-bound per-student cost = $64). Findings presented herein may be used to inform future universal CSA prevention efforts by providing detailed information about the costs of large-scale implementation of an evidence-based program among elementary-aged children.

Virtual Delivery of A School-Based Child Sexual Abuse Prevention Program: A Pilot Study.

Universal child sexual abuse (CSA) prevention is a public health priority. The prevailing prevention strategy is school-based CSA prevention programming. School closures during the COVID-19 pandemic highlighted the need for flexible modes of delivery, including virtual programs. This pilot examined the virtual delivery of an evidence-based, school-based CSA prevention program, Safe Touches, designed to teach CSA-related knowledge and concepts. Using mixed methods, the pilot sought to determine the feasibility of the virtually delivered CSA prevention program. One school district that had previously received Safe Touches in-person participated. A total of 176 second grade students participated in the virtual workshop. Post-workshop survey responses from virtual (N = 37) and in-person workshops (N = 60) were compared descriptively. Mean item scores and response patterns from students who received the virtual workshop were nominally comparable to the student scores from the in-person workshop. Following the virtual workshop, one teacher notified the research team of a disclosure of CSA. Qualitative input from the facilitator and school staff was positive, indicating high student engagement. Results suggest the viability and feasibility of virtual school-based CSA preventive programs. Investment in virtual modes of delivery would ensure all students have access to CSA prevention programming in the future.

A Hybrid Evaluation-Optimization Trial to Evaluate an Intervention Targeting the Intersection of Alcohol and Sex in College Students and Simultaneously Test an Additional Component Aimed at Preventing Sexual Violence.

BACKGROUND: Using the multiphase optimization strategy (MOST), we previously developed and optimized an online behavioral intervention, itMatters, aimed at reducing the risk of sexually transmitted infections (STI) among first-year college students by targeting the intersection of alcohol use and sexual behaviors. PURPOSE: We had two goals: (a) to evaluate the optimized itMatters intervention and (b) to determine whether the candidate sexual violence prevention (SVP) component (included at the request of participating universities) had a detectable effect and therefore should be added to create a new version of itMatters. We also describe the hybrid evaluation-optimization trial we conducted to accomplish these two goals in a single experiment. METHODS: First year college students (N = 3,098) at four universities in the USA were individually randomized in a hybrid evaluation-optimization 2 × 2 factorial trial. Data were analyzed using regression models, with pre-test outcome variables included as covariates in the models. Analyses were conducted separately with (a) immediate post-test scores and (b) 60-day follow-up scores as outcome variables. RESULTS: Experimental results indicated a significant effect of itMatters on targeted proximal outcomes (norms) and on one distal behavioral outcome (binge drinking). There were no significant effects on other behavioral outcomes, including the intersection of alcohol and sexual behaviors. In addition, there were mixed results (positive short-term effect; no effect at 60-day follow-up) of the SVP component on targeted proximal outcomes (students' self-efficacy to reduce/prevent sexual violence and perceived effectiveness of protective behavioral strategies). CONCLUSIONS: The hybrid evaluation-optimization trial enabled us to evaluate the individual and combined effectiveness of the optimized itMatters intervention and the SVP component in a single experiment, conserving resources and providing greatly improved efficiency. TRIAL REGISTRATION: NCT04095065.

Drug Court as an Intervention Point to Affect the Well-Being of Families of Parents with Substance Use Disorders.

Background: A high proportion of justice-involved individuals have a substance use disorder and many of those individuals serve in a caregiving role to a child under 18. Given the negative impact of substance use and justice-involvement on the wellbeing of children, the criminal justice system may offer a unique intervention point with high public health impact. This study describes characteristics of adult drug court participants (DCP) that affect the wellbeing of their children and families and compares the DCP parenting and mental health characteristics to their child's other caregiver in order to understand how parenting differs within drug court families. Method: Data were collected from a sample of 100 DCP; 58 had a matched other caregiver. Drug court data regarding substance use and criminogenic risk/need were collected. Analyses differentiated the parenting behaviors and mental health needs of DCP from other caregivers. Results: The DCP were at moderate to high risk for recidivism and presented with multiple and significant criminogenic and psychosocial functioning needs. Risk for potential maltreatment and poor parenting behaviors were elevated, and significantly higher compared to other caregivers. DCP demonstrated clinically elevated mental health needs, and were significantly different across all indicators of mental health compared to other caregivers. Conclusions: Adult drug courts address the occurrence of substance use disorders but there are additional needs to be intervened upon. Adult drug courts may be a viable intervention point to address issues of parenting and mental health to improve the wellbeing of criminal justice-involved individuals, their children, and families.

Is Sexual Abuse a Unique Predictor of Sexual Risk Behaviors, Pregnancy, and Motherhood in Adolescence?

This study tested sexual abuse as a unique predictor of subsequent adolescent sexual behaviors, pregnancy, and motherhood when in company with other types of maltreatment (physical abuse, neglect) and alternative behavioral, family, and contextual risk factors in a prospective, longitudinal study of maltreated (n = 275) and comparison (n = 239) nulliparous females aged 14-19 years old assessed annually through 19 years old. Hierarchical regression was used to disentangle risk factors that account for the associations of maltreatment type on risky sexual behaviors at 19 years old, adolescent pregnancy, and adolescent motherhood. Findings indicate that sexual and physical abuse remain significant predictors of risky sexual behaviors, and that sexual abuse remains a significant predictor of adolescent motherhood when alternative explanatory variables are controlled.

Systematic Braiding of 2 Evidence-Based Parent Training Programs: Qualitative Results From the Pilot Phase.

An effective approach in early intervention for children and families, including child maltreatment prevention, is home-based services. Although several evidence-based programs exist, they are often grouped or delivered together, despite having different foci and approaches. This article describes the development and pilot phases of a trial evaluating the systematic braiding of 2 evidence-based home-based models, SafeCare and Parents as Teachers. We describe the methodology for braiding model implementation and curriculum, specifically focusing on how structured qualitative feedback from pilot families and providers was used to create the braided curriculum and implementation. Systematic braiding of 2 models at the implementation and curriculum levels is a mechanism that has the potential to meet the more comprehensive needs of families at risk for maltreatment.

Optimization of implementation strategies using the Multiphase Optimization STratgey (MOST) framework: Practical guidance using the factorial design.

The Multiphase Optimization STrategy (MOST) is a framework that uses three phases-preparation, optimization, and evaluation-to develop multicomponent interventions that achieve intervention EASE by strategically balancing Effectiveness, Affordability, Scalability, and Efficiency. In implementation science, optimization of the intervention requires focus on the implementation strategies-things that we do to deliver the intervention-and implementation outcomes. MOST has been primarily used to optimize the components of the intervention related to behavioral or health outcomes. However, innovative opportunities to optimize discrete (i.e. single strategy) and multifaceted (i.e. multiple strategies) implementation strategies exist and can be done independently, or in conjunction with, intervention optimization. This article details four scenarios where the MOST framework and the factorial design can be used in the optimization of implementation strategies: (i) the development of new multifaceted implementation strategies; (ii) evaluating interactions between program components and a discrete or multifaceted implementation strategies; (iii) evaluating the independent effects of several discrete strategies that have been previously evaluated as a multifaceted implementation strategy; and (iv) modification of a discrete or multifaceted implementation strategy for the local context. We supply hypothetical school-based physical activity examples to illustrate these four scenarios, and we provide hypothetical data that can help readers make informed decisions derived from their trial data. This manuscript offers a blueprint for implementation scientists such that not only is the field using MOST to optimize the effectiveness of an intervention on a behavioral or health outcome, but also that the implementation of that intervention is optimized.

The Multiphase Optimization STrategy (MOST) is a method used to create interventions that work well, are cost-effective, and can be used widely. Normally, MOST focuses on making interventions better at improving health or behaviors. This article demonstrates that MOST can also improve how interventions are implemented and provide four examples: (i) the development of a new multipart implementation plan; (ii) evaluating how different parts of an intervention and its implementation plan work together; (iii) evaluating how different parts of a multipart implementation plan work alone and in combination; and (iv) modification of an implementation plan for local context. This article is meant to help scientists who work on putting interventions into practice. It shows how MOST can make interventions better and make sure they are used well in different places. By focusing on both the intervention and the implementation plan, we can do a better job of using interventions that have been proven to work in real life.

Association Between Child Maltreatment and Substance Use Disorder Across Emerging Adulthood.

Child maltreatment is associated with substance use beginning in adolescence and throughout early adulthood. Substance use disorders (SUD) are most likely to develop during emerging adulthood (18-25 years old). Thus, to develop effective substance use prevention strategies, it is useful to know the ages at which associations between maltreatment exposure (prior to age 18) and SUD are most strongly tied. This study examined the age-varying association between child maltreatment and past-year SUD in emerging adulthood by sex and by maltreatment type using time-varying effect models (TVEM). Data were from the National Epidemiological Survey on Alcohol and Related Conditions (NESARC-III). The analytic sample consisted of 5194 emerging adults. The association was strongest at younger ages, with individuals who experienced child maltreatment having three times greater odds of reporting SUD in the past-year. Differential associations were found by sex, racial-ethnic group, and maltreatment type across age. Prevention efforts may be more effective if their development is informed by these important differences and targeted at emerging adults rather than adolescents.

Firearm screening and secure storage counseling among home visiting providers: a cross-sectional study of SafeCare® providers in the U.S.

Background: Firearms used in pediatric firearm deaths are most often obtained from the child's home, making secure firearm storage initiatives imperative in prevention efforts. Evidence-based home visiting (EBHV) programs are implemented with over 277,000 families annually, providing an opportunity for secure firearm storage counseling. The purpose of this study was to assess EBHV providers' experiences with firearm screening ("assessment"), secure storage counseling, and their perceptions for related training needs. Methods: Providers in the U.S. from SafeCare®, an EBHV program often implemented with families experiencing increased risk of child neglect and physical or emotional abuse, were invited to participate in a survey to examine firearm assessment and attitudes toward and experiences with firearm safety counseling. Survey items were primarily Likert scale ratings to indicate level of agreement, with some open-ended follow-up questions. Descriptive statistics (i.e., frequencies and percentages) were used to report item-level agreement. A post hoc analysis was conducted using Spearman correlation to examine the association between assessment and counseling and provider-level factors. Results: Sixty-three SafeCare providers consented to and completed the survey items. Almost three-quarters (74.6%) agreed/strongly agreed that they assess in-home firearm availability. However, 66.7% agreed/strongly agreed that they have not been adequately trained to discuss firearm safety topics. A substantial proportion (80.6%) indicated they would counsel more if materials and training on this topic were available. Response variability emerged by level of urbanicity. A post hoc analysis found that providers' self-reported frequency of assessment and counseling were associated with their comfort level discussing firearm safety and whether or not they had worked with families impacted by firearm injury. Conclusion: SafeCare providers report a need for materials and training on secure firearm storage, and a willingness to provide more counseling with proper training to the families they serve. Findings illuminate the need for secure storage initiatives for EBHV programs, which have broad service reach to a substantial number of at-risk U.S. families annually.

Piloting an Alternative Implementation Modality for a School-Based Child Sexual Abuse Prevention Curriculum.

BACKGROUND: In the U.S., the most pervasive child sexual abuse (CSA) prevention strategy involves school-based prevention programs; however, the reach of these programs is limited due to implementation constraints, such as budgets or turnover. This is notable as standard delivery of often requires two facilitators in the classroom. Leveraging a natural experiment in the implementation of Safe Touches, the current study sought to explore the feasibility of implementation with a single facilitator using pre-recorded videos compared to the standard in-person delivery. METHODS: A six-item CSA-related knowledge questionnaire was delivered to (N = 1480) second-graders post-workshop. An independent-samples t-test was used to compare the mean of CSA-related knowledge item responses for each delivery modality. Student-level data were paired with teacher evaluations and an interview with the facilitator. RESULTS: Across workshops delivered in 25 schools, there was no significant difference in knowledge based on CSA-related questions by workshop modality. Teachers indicated the facilitators responded effectively to the children's questions and comments in both delivery modalities. Input from the facilitator was positive. CONCLUSIONS: Triangulation of student knowledge, teacher input, and facilitator experience indicates the viability and feasibility of this implementation strategy for Safe Touches, and potentially other school-based CSA prevention programs. To ensure equitable access to the CSA prevention program, the empirical examination of, and investment in, alternative implementation options for school-based CSA preventive programs is encouraged.

Adapting a selective parent-focused child sexual abuse prevention curriculum for a universal audience: A pilot study.

Parents are an obvious, but underutilized player in the prevention of child sexual abuse (CSA). A handful of universal parent-focused prevention programs have emerged, however, the evidence for these programs is mixed and the programs suffer ubiquitously from barriers to implementation (e.g., poor engagement, low participation) thereby limiting public health impact. To combat these barriers and improve evidence, researchers previously developed and tested a selective parent-focused CSA prevention program. While promising, the selective approach still leaves a gap in the prevention landscape-parents from the universal audience. However, there appear to be no standardized methods to inform this type of adaptation-interventions designed as universal or selective have primarily been delivered as such. This study sought to adapt the selective curriculum for a universal audience and examined the acceptability and feasibility of the program for evaluation in a future trial. Using mixed methods, N = 31 parents (i.e., primary caregiver for a child under 13) completed pre- and post-workshop surveys followed by a brief individual interview conducted via Zoom. Interviews, coded using content analysis methods, focused on three themes: parents as agents of prevention (e.g., prior action, confidence), curriculum (e.g., content, design), and engagement (e.g., future marketing and promotion). Overall participants' mean score on CSA-related awareness and intention to use protective behavioral strategies increased. The participants found the curriculum highly acceptable noting strengths in the content and design. All told, the results of this pilot study suggest the acceptability and feasibility of examining the efficacy of the universal parent-focused curriculum in a larger trial. Procedural challenges, such as bots in recruitment, identify areas of caution in design of the larger trial and a roadmap for others seeking to adapt selective programs for universal audiences.

StandUPTV: Preparation and optimization phases of a mHealth intervention to reduce sedentary screen time in adults.

Recreational sedentary screen time (rSST) is the most prevalent sedentary behavior for adults outside of work, school, and sleep, and is strongly linked to poor health. StandUPTV is a mHealth trial that uses the Multiphase Optimization Strategy (MOST) framework to develop and evaluate the efficacy of three theory-based strategies for reducing rSST among adults. This paper describes the preparation and optimization phases of StandUPTV within the MOST framework. We identified three candidate components based on previous literature: (a) rSST electronic lockout (LOCKOUT), which restricts rSST through electronic means; (b) adaptive prompts (TEXT), which provides adaptive prompts based on rSST behaviors; and (c) earning rSST through increased moderate-vigorous physical activity (MVPA) participation (EARN). We also describe the mHealth iterative design process and the selection of an optimization objective. Finally, we describe the protocol of the optimization randomized controlled trial using a 23 factorial experimental design. We will enroll 240 individuals aged 23-64 y who engage in >3 h/day of rSST. All participants will receive a target to reduce rSST by 50% and be randomized to one of 8 combinations representing all components and component levels: LOCKOUT (yes vs. no), TEXT (yes vs. no), and EARN (yes vs. no). Results will support the selection of the components for the intervention package that meet the optimization objective and are acceptable to participants. The optimized intervention will be tested in a future evaluation randomized trial to examine reductions in rSST on health outcomes among adults.