Maximizing the reach of universal child sexual abuse prevention: Protocol for an equivalence trial.

Background: Child sexual abuse (CSA) affects 1 in 5 girls and 1 in 12 boys before age 18. Universal school-based prevention programs are an effective and cost-efficient method of teaching students an array of personal safety skills. However, the programmatic reach of universal school-based programs is limited by the inherent reliance on the school infrastructure and a dearth of available alternative delivery modalities. Methods: The design for this study will use a rigorous cluster randomized design (N = 180 classrooms) to determine the equivalence of two delivery modalities of Safe Touches: as usual vs. modified. The as usual workshop will be delivered by two facilitators with live puppet skits (n = 90). Whereas, the modified workshop will be delivered by one facilitator using prerecorded skit videos (n = 90). We will determine the equivalence by measuring concept learning acquisition preworkshop to immediate postworkshop (Aim 1) and retention at 3-months postworkshop (Aim 2) among students in classrooms that receive the as usual or modified workshops. To conclude equivalence, it is imperative to also examine factors that may impact future dissemination and implementation, specifically program adoption among school personnel and implementation fidelity between the two modalities (Aim 3). Conclusion: Study findings will inform the ongoing development of effective CSA prevention programs and policy decisions regarding the sustainable integration of such programs within schools. Clinical trial registration: NCT06195852.

Applying the resource management principle to achieve community engagement and experimental rigor in the multiphase optimization strategy framework.

Preventing and treating mental health and substance use problems requires effective, affordable, scalable, and efficient interventions. The multiphase optimization strategy (MOST) framework guides researchers through a phased and systematic process of developing optimized interventions. However, new methods of systematically incorporating information about implementation constraints across MOST phases are needed. We propose that early and sustained integration of community-engaged methods within MOST is a promising strategy for enhancing an optimized intervention's potential for implementation. In this article, we outline the advantages of using community-engaged methods throughout the intervention optimization process, with a focus on the Preparation and Optimization Phases of MOST. We discuss the role of experimental designs in optimization research and highlight potential challenges in conducting rigorous experiments in community settings. We then demonstrate how relying on the resource management principle to select experimental designs across MOST phases is a promising strategy for maintaining both experimental rigor and community responsiveness. We end with an applied example illustrating a community-engaged approach to optimize an intervention to reduce the risk for mental health problems and substance use problems among children with incarcerated parents.

Strategies for Engaging Communities and Ensuring Research Quality in the Multiphase Optimization Strategy Plain Language Summary What is already known about the topic? Interventions must be effective, affordable, scalable, and efficient to be successfully implemented and achieve maximum public health impact. The multiphase optimization strategy is a strategic and phased approach to developing optimized interventions. Community-engaged research has been used to bolster an intervention's potential for implementation.What does this paper add? The article guides researchers who are employing community-engaged research methods to systematically conduct activities in different phases of the intervention optimization process. The end goal is to create an optimized intervention ready for successful implementation in its intended delivery setting.What are the implications for practice, research, or policy? Incorporating input from key stakeholders in every phase of the intervention optimization process can enhance the public health impact of community-based interventions for mental health and substance use problems.

Increasing pre-exposure prophylaxis (PrEP) in primary care: A study protocol for a multi-level intervention using the multiphase optimization strategy (MOST) framework.

BACKGROUND: In the United States, over 1.2 million people are living with HIV. This disease disproportionately affects men who have sex with men (MSM), people of color, youth and young adults, and transgender individuals. Pre-exposure prophylaxis (PrEP) is an effective HIV prevention method. Barriers exist for both primary care providers (PCPs) to prescribe PrEP and prevent patients from initiating PrEP. METHODS: This study, MOST: PrEP, follows the multiphase optimization strategy (MOST) framework. The purpose is to identify a multi-level intervention among patients and PCPs to increase PrEP prescriptions in primary care. First, feedback will be obtained from providers and patients via focus groups, then, suggestions related to the context-specific (provider and individual level) factors of intervention component delivery will be incorporated. Subsequently, a rigorous experiment will be conducted using a 24 factorial design focusing on priority populations for PrEP initiation. Provider components include computer-based simulation training and a best practice alert. Patient components include a tailored PrEP educational video and HIV risk assessment. Finally, the facilitators and barriers to implementing the intervention components will be qualitatively examined. CONCLUSION: In this protocol paper, we describe the one of the first known multilevel MOST optimization trial in healthcare. Intervention components are to be delivered to patients and providers in a large healthcare system, based in an HIV Ending the Epidemic priority jurisdiction. If effective, this multi-level approach could be disseminated to providers and patients in other large healthcare systems to make a significant impact on HIV prevention.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Adapting prevention programs for virtual delivery: A case study in adapting a parent-focused child sexual abuse prevention module.

Background: Evolving and emerging contexts require interventions to respond and adapt. The COVID-19 pandemic necessitated a quick adaptation from in-person to virtual delivery. Not only were there few programs able to transition to virtual delivery, there was a lack of parent-focused CSA-prevention programs. The current study describes the responsive adaptation of a parent-focused child sexual abuse (CSA) prevention module (Smart Parents-Safe and Healthy Kids; SPSHK) for virtual delivery. Design and methods: This two-phase study used mixed-methods to inform and pilot test adaptations to the virtual module. In Phase 1, parenting providers with and without experience delivering SPSHK (N = 110) completed anonymous surveys and a subsample (n = 27) subsequently participated in brief interviews elaborate on challenges and needed adaptations for virtual platforms. Results: Providers indicated the greatest technological difficulties with parents' access to technology noting the inability to use a screensharing function. Thus, providers recommended no adaptations for the virtual delivery of SPSHK. In Phase 2, the virtual SPSHK module was piloted with nine parents. Results demonstrated virtual SPSHK was acceptable and feasibly implemented. Pre-posttest assessments indicated increases in parents' CSA-related awareness and use of protective behaviors. Conclusion: The current study suggests the promise of virtual SPSHK implementation and may act as a blueprint for other parent-focused CSA-prevention programs, but also more general parenting programs, considering virtual delivery.

Guidance on selecting a translational framework for intervention development: Optimizing interventions for impact.

Intervention development frameworks offer the behavioral sciences a systematic and rigorous empirical process to guide the translation of basic science into practice in pursuit of desirable public health and clinical outcomes. The multiple frameworks that have emerged share a goal of optimization during intervention development and can increase the likelihood of arriving at an effective and disseminable intervention. Yet, the process of optimizing an intervention differs functionally and conceptually across frameworks, creating confusion and conflicting guidance on when and how to optimize. This paper seeks to facilitate the use of translational intervention development frameworks by providing a blueprint for selecting and using a framework by considering the process of optimization as conceptualized by each. First, we operationalize optimization and contextualize its role in intervention development. Next, we provide brief overviews of three translational intervention development frameworks (ORBIT, MRC, and MOST), identifying areas of overlap and divergence thereby aligning core concepts across the frameworks to improve translation. We offer considerations and concrete use cases for investigators seeking to identify and use a framework in their intervention development research. We push forward an agenda of a norm to use and specify frameworks in behavioral science to support a more rapid translational pipeline.

Decision support training for advanced cancer family caregivers: Study protocol for the CASCADE factorial trial.

BACKGROUND: Patients with advanced cancer face numerous decisions when diagnosed and often receive decision support from family caregivers. The CASCADE (CAre Supporters Coached to be Adept DEcision partners) factorial trial intervention aims to train caregivers in skills to provide effective decision support to patients and identify most effective intervention components. METHODS: This is a 2-site, single-blind, 24 factorial trial to test components of the CASCADE decision support training intervention for family caregivers of patients with newly-diagnosed advanced cancer delivered by specially-trained, telehealth, palliative care lay coaches over 24 weeks. Family caregivers (target N = 352) are randomly assigned to one of 16 combinations of four components with two levels each: 1) psychoeducation on effective decision partnering principles (1 vs. 3 sessions); 2) decision support communication training (1 session vs. none); 3) Ottawa Decision Guide training (1 session vs. none) and 4) monthly follow-up (1 call vs. calls for 24 weeks). The primary outcome is patient-reported decisional conflict at 24 weeks. Secondary outcomes include patient distress, healthcare utilization, caregiver distress, and quality of life. Mediators and moderators (e.g., sociodemographics, decision self-efficacy, social support) will be explored between intervention components and outcomes. Results will be used to build two versions of CASCADE: one with only effective components (d ≥ 0.30) and another optimized for scalability and cost. DISCUSSION: This protocol describes the first factorial trial, informed by the multiphase optimization strategy, of a palliative care decision-support intervention for advanced cancer family caregivers and will address the field's need to identify effective components that support serious illness decision-making. TRIAL REGISTRATION: NCT04803604.

Systematic braiding of Smoke-Free Home SafeCare to address child maltreatment risk and secondhand smoke exposure: findings from a pilot study.

BACKGROUND: Exposure to secondhand tobacco smoke (SHS) and child maltreatment are preventable threats to child health. Few evidence-based interventions target both SHS and child maltreatment risk. The purpose of this paper is to describe the systematic braiding process of two evidence-based programs to address child SHS in the home and maltreatment perpetration risk, and present results from the formative work and pilot study. METHODS: The first 4 steps of the systematic braiding process were completed, including the following: (1) the identification of core elements of both programs, (2) the development of an initial draft of the braided curriculum (Smoke-Free Home SafeCare - SFH-SC), (3) an acceptability and feasibility pilot of SFH-SC with caregivers of young children who reported a smoker living in the home (N = 8), and (4) feedback collection on the braided curriculum from SafeCare Providers (N = 9). RESULTS: Experts identified common pedagogical and theoretical underpinnings for the two programs and braided Smoke-Free Homes: Some Things Are Better Outside into two SafeCare modules. Caregiver feedback from the pilot demonstrated that participants were engaged with SFH-SC and felt supported and comfortable discussing SHS intervention content with the SFH-SC Provider. Caregiver self-reports indicated a slight increase in smoke-free home rules from baseline to follow-up and a notable reduction in parent stress on the Parent Stress Index of 5.9 points (SD = 10.2). SafeCare Provider feedback following intensive review of the curriculum indicated high feasibility for SFH-SC delivery. CONCLUSIONS: Parent and Provider findings suggest SFH-SC is a viable intervention that has potential to reduce the public health impact of SHS and child maltreatment for at-risk families. PROTOCOL: The protocol for the pilot is not published elsewhere; however, the full protocol for the hybrid trial can be found here: https://clinicaltrials.gov/ct2/show/NCT05000632 . TRIAL REGISTRATION: NCT, NCT05000632. Registered 14 July 2021, there is not a separate registration number for the pilot.