Kate Guastaferro
Kate Guastaferro
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Assistant Professor of Social and Behavioral Sciences
Co-Director of the Center for the Advancement and Dissemination of Intervention Optimization
Director of the Doctor of Public Health (DrPH) Program
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Professional overview
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Kate Guastaferro, PhD is an intervention scientist by training, her work is devoted to the development, optimization, implementation and evaluation of effective, efficient, affordable and scalable interventions with high public health impact. She is an expert in the multiphase optimization (MOST) strategy and her expertise is in parent-focused, multicomponent behavioral interventions to prevent child maltreatment. Dr. Guastaferro co-led a statewide trial focused on the coordinated implementation of three evidence-base child sexual abuse prevention programs; included in this trial was the parent-focused child sexual abuse program that she developed, piloted and evaluated. Her current work is focused on the integration of intervention optimization into the prevention of child maltreatment.
Prior to joining NYU, Dr. Guastaferro was an assistant research professor in human development and family studies at the Pennsylvania State University, and an affiliate of its Prevention Research Center and Child Maltreatment Solutions Network. In 2020, she was awarded the Victoria S. Levin Award for Early Career Success in Young Children’s Mental Health Research from the Society for Research in Child Development. She has been published in Child Maltreatment, Translational Behavioral Medicine, and the American Journal of Public Health.
Dr. Guastaferro received her PhD and MPH from Georgia State University’s School of Public Health, and her BA in anthropology from Boston University. She also completed a year of postdoctoral training at the Pennsylvania State University.
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Education
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Postdoctoral Fellow, Prevention and Methodology Training Program (T32 DA017629), The Pennsylvania State UniversityPhD Public Health, Georgia State UniversityMPH Health Promotion, Georgia State UniversityBA Anthropology, Boston University
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Honors and awards
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Victoria S. Levin Award, Society for Research on Child Development (2020)NIH Loan Repayment Program Award: Toward the Optimization of Behavioral Interventions to Prevent Child Maltreatment (201820192020)Public Health Achievement Award, Georgia State University (2016)Scarlet Key Honor Society, Boston University (2008)
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Publications
Publications
Co-Developed Community-Based Health Interventions with Children Under 18 and Families Experiencing Homelessness in High-Income Countries: A Systematic Review
AbstractRosenthal, D. M. M., Kubik, J., Loureiro, S., Guastaferro, K., & Goodman, M. (n.d.).Publication year
2026Journal title
HealthcareVolume
14Issue
4AbstractDespite the implementation of numerous evidence-based interventions, the 2024 Point-in-Time count in the United States (U.S.) reported that 259,473 people in families with children under 18 years old were experiencing homelessness, a record high since the count began in 2007. Recent findings suggest that co-developed interventions may increase engagement with vulnerable populations and, in turn, the effectiveness of health-based programs among them.Co-developing SHELTER (Safe, Healthy Environments and Local Transformation for Equity and Resilience) with families with lived experience of homelessness in the New York City shelter system: A community needs assessment and data collection protocol
AbstractRosenthal, D. M. M., Guastaferro, K., Kubik, J., & Goodman, M. (n.d.).Publication year
2026Journal title
PloS ONEVolume
21Issue
1Page(s)
e0341718AbstractIn January 2025, the nightly census revealed that over 120,000 people were staying in New York City (NYC) shelters, including more than 41,000 children, of whom almost half were aged 0-5 years. Children under five years old (under-5s) experiencing homelessness are especially vulnerable because the first five years of life are a critical period for child growth, including approximately 90% of brain development. Furthermore, under-5s experiencing homelessness have a higher risk for multiple adverse childhood experiences, developing chronic health conditions, and recurrent homelessness across the life course. Data available for under-5s experiencing homelessness is generally lacking, and what is available is of notably poor quality in the United States, leaving a wide evidence gap and an inability to determine the actual needs of this population. This proposed protocol employs community-based participatory research and was co-developed with families with under-5s who have lived experience of homelessness in NYC shelters. The aim is to determine what barriers exist in the physical and social environments to optimizing health and wellbeing (e.g., milestones, child mental health, parental mental health, safety) among under-5s living in NYC shelters. Using a sequential mixed-methods design, we propose to address a gap in the current literature by conducting an assets- and deficits-based health needs assessment comprising a quantitative survey and qualitative semi-structured interviews. In the long term, our objective is to enhance the quality and quantity of data for this vulnerable population, thereby laying the groundwork for the future co-development of a comprehensive, optimized intervention addressing the needs of under-5s experiencing homelessness.Exploring Predictors of Implementation Fidelity: Baseline Provider Self-Efficacy and Attitudes Towards the Addition of a Child Sexual Abuse Prevention Module to Home Visiting
AbstractAbourjaily, E., Abuchaibe, V., & Guastaferro, K. (n.d.).Publication year
2026Abstract~Outcome measurement for a school-based child sexual abuse prevention intervention amidst national reading-level delays
AbstractAbourjaily, E., Gjelsvik, A., & Guastaferro, K. (n.d.).Publication year
2026Abstract~Preliminary validation of a structured interview to assess parents' practical implementation of behavioral strategies for child sexual abuse prevention
AbstractAbourjaily, E., Wortham, W., Abuchaibe, V., Self-Brown, S., & Guastaferro, K. (n.d.).Publication year
2026Journal title
Child Abuse & NeglectVolume
176Page(s)
108032AbstractChild sexual abuse (CSA) is a pervasive public health problem requiring parental action. While evidence supporting the effectiveness of parent-focused CSA prevention programs is growing, current measures focus on parent knowledge, awareness, and intentions to use preventive behaviors. This challenges the establishment of a robust evidence-base. The current study presents preliminary validation of a new tool to address this gap.The HIV Pre-Exposure Prophylaxis (PrEP) Initiation Cascade: Patient Experiences with the Health Care System Before Starting PrEP
AbstractLockhart, E., Turner, D., Alsutan, A., Berezin, M., Guastaferro, K., Pittiglio, B., Torres-Alzate, H., Szalacha, L., & Marhefka, S. (n.d.).Publication year
2026Journal title
AIDS and BehaviorAbstract~Theory-based approach to increasing enrollment in a universal parent-focused child sexual abuse prevention workshop
AbstractAbourjaily, E., Myrick, J. G., & Guastaferro, K. (n.d.).Publication year
2026Journal title
Health Promotion PracticeAbstractChild sexual abuse (CSA) is a public health concern of considerable magnitude requiring universal attention and prevention efforts. All parents have the potential to prevent CSA when provided the knowledge and skills to do so; however, engagement in universal prevention is a widely faced challenge that threatens the dissemination of such knowledge and skills into parents’ hands. Albeit widely faced, this challenge is poorly understood and largely unaddressed—indicative of a clear need for innovative solutions to promote engagement in universal prevention programs. The purpose of this study was to evaluate the use of communication theory-driven recruitment materials by gauging potential engagement. Participants (N = 350) recruited from Prime Panels by CloudResearch were shown three flyers, each depicting a distinct message rooted in communication science theory. Participants were asked questions related to their emotional reactions and potential engagement with the individual materials should they have seen them in their day-to-day lives, before viewing all three flyers side-by-side wherein questions were posed to evoke comparison. Results were analyzed quantitatively with analysis of covariance (ANCOVA) and path analyses, as well as qualitatively leveraging a phenomenological approach. Findings indicate issue salience and efficacy as consistent positive predictors on emotions and intentions. They further display that appealing to both mixed emotions and higher intensity emotions are key to motivating action. Sociodemographic predictors of emotions and intentions varied across communication theories. Overall, this study demonstrates the potential for increased engagement in universal prevention interventions by way of theory-based recruitment communications curated to the targeted population.A Quasi-Experimental Trial of Universal Parent-Focused Child Sexual Abuse Prevention Program: Recruitment Practicalities and Pitfalls
AbstractTorney, I., Abourjaily, E., & Guastaferro, K. (n.d.).Publication year
2025Abstract~A Scoping Review: Are U.S. Teachers Equipped to Prevent Child Sexual Abuse?
AbstractMartin, C., Melchior, M. S., Chasen, E., & Guastaferro, K. (n.d.).Publication year
2025Abstract~A Site-Specific and Temporal Analysis of a School-Based Child Sexual Abuse Prevention Program
AbstractModi, P., Abourjaily, E., Torney, I., & Guastaferro, K. (n.d.).Publication year
2025Abstract~Adapting a sexual and reproductive health program for Latina teens and their female caregivers: A qualitative study
AbstractMerrill, K. G., Fuentes, J., Merrill, J., DeCelles, J., Silva, J., Sedeño, A., Salgado, S., Vargas, S., Cano, J. K., Nabor, V., Rodriguez, L., Melgoza, V., Mora, C., Baumann, A. A., Guastaferro, K., & Donenberg, G. R. (n.d.).Publication year
2025Journal title
Frontiers in Public HealthVolume
13AbstractBackground: Adaptation is widely recognized as important when interventions are to be delivered in new settings or with new populations. However, there are gaps in the literature on how adaptations are carried out and documented. IMARA is a 12-h evidence-based sexual health intervention for Black teens and their mothers, designed for delivery over two days. We present our systematic process of adapting IMARA for Latinas to produce the Floreciendo (“Blooming”) program for Latina teens (14–18 years old) and their female caregivers (e.g., mothers, sisters). Methods: Using a community-based participatory research (CBPR) approach, we carried out a qualitative study that included 7 focus groups: 4 with staff from community partner organizations (n = 29), 2 with Latina teens (14–18 years) (n = 11), and 1 with female caregivers (n = 5). We also conducted seven key informant interviews with experts in sexual health and Latina health. We used Escoffery’s recommended steps to guide our adaptation process. Data were thematically coded and adaptations documented using the FRAME for reporting modifications to evidence-based interventions. Results: Informed by the data, we grouped IMARA content into four sessions for Floreciendo, each with unique curricular content and designed to be delivered in two hours (eight hours total): (1) Foundations in Sexual Risk Prevention; (2) Condoms and Contraception; (3) Family Strengthening; and (4) Gender and Relationships. We documented adaptations made for each session. For example, participants emphasized unplanned pregnancy as an important issue facing Latina teens. In response, we added an activity providing hands-on experience with contraceptive methods. Participants also highlighted how gender norms and family expectations in Latine culture shape Latina teens’ sexual and reproductive health practices. We therefore developed activities and opportunities for discussion addressing these cultural influences. We removed IMARA activities considered of lower priority (e.g., portrayal of women in the media). Conclusion: This study addresses gaps in the literature by reporting in detail the adaptations we made to an evidence-based intervention using qualitative methods. The four curriculum sessions we generated through our adaptation process will form the basis of the intervention components we will test in future work using the multiphase optimization strategy (MOST) framework.Adding a child sexual abuse prevention module to home visiting: Exploring provider self-efficacy and acceptability as predictors of implementation fidelity
AbstractAbourjaily, E., Abuchaibe, V., & Guastaferro, K. (n.d.).Publication year
2025Abstract~Child maltreatment
AbstractGuastaferro, K., & Lutzker, J. R. (n.d.). (J. C. V. & & D. J. Cox, Eds.).Publication year
2025Abstract~Coordinated Primary Prevention of Child Sexual Abuse: Project Safe & Smart at Weller Health Education
AbstractGuastaferro, K., Rainey, M., Escueta, A., Abourjaily, E., & Hoben, K. (n.d.).Publication year
2025Abstract~Development of a Secure Firearm Storage Module for Evidence-Based Home Visiting: A Proposed Pilot Optimization Trial
AbstractOsborne, M. C., Guastaferro, K., & Self-Brown, S. R. (n.d.).Publication year
2025Abstract~Enhancing home visiting with a parent-focused child sexual abuse prevention program: Smart Parents Study
AbstractAbuchaibe, V., Abourjaily, E., & Guastaferro, K. (n.d.).Publication year
2025Abstract~Enhancing occupational therapy interventions by integrating the multiphase optimization strategy framework
AbstractRosenfeld, M., Goverover, Y., & Guastaferro, K. (n.d.).Publication year
2025Journal title
American Journal of Occupational TherapyVolume
79Issue
1AbstractThe pursuit of evidence-based interventions has long been a cornerstone of the occupational therapy profession. However, challenges persist regarding systematic development of interventions, evaluation of efficacy and effectiveness, as well as implementation and dissemination of interventions within clinical . This article introduces the Multiphase Optimization Strategy (MOST), an engineering-inspired framework for the development, optimization, and evaluation of multicomponent interventions. MOST allows the systematic development and evaluation of optimized interventions that prioritize effectiveness within constraints like affordability, scalability, and efficiency. Employing MOST while developing an intervention can potentially reduce the delay between intervention creation and implementation. Furthermore, adopting MOST will bolster the use of rigorous research designs in occupational therapy studies and foster shared terminology with other disciplines that have successfully applied this framework across a range of health priorities and conditions. Thus, in this article, we advocate for the integration of MOST into occupational therapy intervention development research.Evaluating smoking cessation interventions for people living with HIV in a factorial randomised clinical trial in South Africa using the Multiphase Optimization Strategy (MOST) framework : The Tlogela Trial protocol
AbstractGuastaferro, K. (n.d.).Publication year
2025Journal title
Contemporary Clinical TrialsVolume
155AbstractBackground: Human immunodeficiency virus (HIV) remains an important cause of morbidity and mortality in South Africa (SA) with a gradual shift from opportunistic illness to pulmonary and cardiovascular disease among people living with HIV (PLWH). This shift is exacerbated by increases in prevalence of tobacco smoking and also few resources to support smoking cessation. Evidence-based smoking cessation strategies are yet to be fully evaluated among PLWH in this setting. Objective: This project will optimize a smoking cessation treatment package for PLWH that can be integrated into existing HIV care in SA. We will identify the most effective and/or combination of the interventions and evaluate their potential for implementation and cost-effectiveness. Methods: A balanced 24 full factorial clinical trial will randomise 660 PLWH who smoke tobacco into one of 16 combinations of four intervention components (behavioural counselling, peer counselling, varenicline, and combination nicotine replacement therapy). Participants will be recruited from four healthcare facilities in SA, receive 12 weeks of intervention and the primary outcome will be 7-day point prevalence tobacco abstinence from smoking at one year, measuring both exhaled breath carbon monoxide (CO) and urinary cotinine. A mixed methods approach will be used to evaluate implementation using the Reach, Effectiveness, Adoptions, Implementation, Maintenance framework. Cost, cost-effectiveness, and budget impact of each intervention combination will be evaluated. Conclusion: Results will inform which intervention components, and in what combination, are most efficacious in supporting smoking abstinence among PLWH in SA and those that have the greatest potential for effectiveness when brought to scale. Clinical Trial Registration Number: South African National Clinical Trials Registry. Trial No: DOH-27-062023-9076. ClinicalTrials.govMandated Reporting in New York State: A Policy Note
AbstractMelchior, M., & Guastaferro, K. (n.d.).Publication year
2025Abstract~Optimizing Psychological Treatment for Pain after Breast Cancer using a Randomized Factorial Design: A Feasibility Study
AbstractBuskbjerg, C. R., Johannsen, M., Norskov, C. C., Jensen, A. B., Frederiksen, Y., Egerod, I., Guastaferro, K., Johansen, C., von Heymann, A., Speckens, A., O’Toole, M. S., & Zacharaie, R. (n.d.).Publication year
2025Journal title
Scandinavian Journal of PsychologyAbstractContext: Psychological treatment has shown promising results in the treatment of pain after breast cancer but could benefit from treatment optimization. Objective: The present mixed-methods study evaluated the feasibility of applying the Multiphase Optimization Strategy for optimizing psychological treatment for pain after breast cancer using treatment components drawn from third-wave cognitive behavioral therapy. Methods: Using a factorial, experimental design, women with pain after breast cancer were randomized to eight experimental conditions consisting of either zero, one, two, or three treatment components, namely Mindful Attention, Decentering, and Values and Committed Action. Primary outcomes of pain intensity and pain interference, secondary outcomes, and presumed change processes were measured at baseline and post-intervention. Semi-structured interviews were conducted at post-intervention. The study took place at Aarhus University in Denmark, and all sessions and interviews were conducted online. Results: Three participants dropped out, and one withdrew consent and was excluded from the intention-to-treat analysis. Time x group-analysis (N=33) demonstrated preliminary effects ranging from medium-sized negative effects (g=-0.51; 95%CI=-1.22-0.20) to large positive effects (g=1.07; 95%CI=0.32-1.82) on primary outcomes. Qualitative manifest content analysis indicated validity of treatment components and overall participant satisfaction. Conclusions: The study results indicate that the project procedures and treatment components are feasible and valid and illustrate how the Multiphase Optimization Strategy framework can be applied for the development of an optimized intervention for pain after breast cancer. We therefore recommend proceeding with a larger scale trial which can provide sufficient statistical power to evaluate the effects of the individual and combined treatment components.Pilot optimization trial of a sexual and reproductive health program for Latina teens and female caregivers: A study protocol
AbstractMerrill, K. G., Silva, J., Chu, W., Robermo, G., Melgoza, V., Gabino, B., Mora, C., Vargas, S., Fuentes, J., Keller-Montero, C., Courreljolles, N., Guastaferro, K., Scott-Wellington, F., Salgado, S., & Sedeno, A. (n.d.).Publication year
2025Journal title
Contemporary Clinical TrialsAbstract~Population-level reductions in child sexual abuse valid and invalid cases after a three-year coordinated, community-wide prevention initiative: Results from a synthetic control analysis
AbstractNoll, J. G., Felt, J., Russotti, J., Guastaferro, K., Day, S., & Fisher, Z. (n.d.).Publication year
2025Journal title
JAMA PediatricsAbstractImportance: Child sexual abuse (CSA) impacts 15% of girls and 8% of boys worldwide, incurring high public costs and devastating consequences for survivors. US incidence rates have stagnated over the past 15 to 20 years, signaling a dire need for innovation in primary prevention. In 2024, the US Preventive Services Task Force reported that there is insufficient evidence for the effectiveness of child abuse preventive strategies, and none have shown decreases in incidence rates at the population level. Objective: To test whether a coordinated, community-wide preventive intervention could significantly reduce population-level incidence rates of CSA. Design, Setting, and Participants: This population cohort study used synthetic control methods with a counterfactual condition and CSA incidence data from a statewide child welfare information system. Participants included a population-based sample in the state of Pennsylvania. Intervention: From 2018 through 2020, the state of Pennsylvania launched a 3-pronged CSA prevention intervention in 5 counties that included: (1) exposing 5% of the adult population (approximately 72000) to online and in-person trainings with an accompanying countywide media campaign, (2) delivering a psychoeducation program to 100% of second-grade students (approximately 17000), and (3) providing parent training to 100% of parents served by the child welfare system (approximately 300). Intervention counties were a priori matched to 1 of 5 control counties based on population size and preintervention CSA rates. Main Outcomes and Measures: Aggregate rates of both substantiated and unsubstantiated CSA reports were examined across intervention and control counties for 5 preintervention years and 3 postintervention years. Results: Within 1 year of intervention launch, CSA reports were significantly reduced in intervention counties, as compared with control counties for both substantiated (average treatment of the treated [ATT] =-17.22; 95% CI,-34.15 to-4.20) and unsubstantiated reports (ATT =-36.04; 95% CI,-74.40 to-3.88). Conclusions: In this evaluation of a place-based, coordinated, countywide intervention, reports of both substantiated and unsubstantiated CSA were shown to be significantly reduced at the population level.Preparing to implement the Floreciendo sexual and reproductive health workshop: Integrating implementation science and the MOST framework
AbstractMerrill, K. G., Silva, J., Sedeno, A., Salgado, S., Vargas, S., Cano, J., Nabor, V., Merrill, J., DeCelles, J., Guastaferro, K., Baumann, A., Fuentes, J., Rodriguez, L., & Donenberg, G. (n.d.).Publication year
2025Journal title
Translational Behavioral MedicineVolume
15Issue
1AbstractBackground: Practical examples of studies integrating implementation science with the multiphase optimization strategy (MOST) framework are lacking. Floreciendo is a workshop for Latina teens and their female caregivers addressing sexual and reproductive health and related issues (e.g., mental health, intimate partner violence), which was adapted from the IMARA evidence-based program. We set out to explore implementation determinants (i.e., barriers and facilitators) and strategies to prepare for a pilot optimization trial of Floreciendo in the preparation phase of MOST. Methods: Using community-based participatory research, we integrated the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework with the MOST framework. We sought to explore determinants of and strategies for achieving five implementation outcomes: acceptability, appropriateness, feasibility, adoption, and sustainability. We conducted seven focus group discussions with Latina teens (n=1 group), female caregivers (n=1 group), staff from three community partner organizations (n=4 groups), and facilitators/implementers of IMARA (n=1 group). We also conducted seven key informant interviews with individuals experienced with sexual and Latina health. Data were analyzed using rapid qualitative analysis. Results: Community partner organizations were the preferred location for workshops in offering a “safe space.” Participants recommended delivering the program on two days over separate weekends. Implementation barriers were raised (e.g., work conflicts, caring for younger children, lack of transport) with strategies to address them (e.g., provide stipends, offer childcare, offer transport reimbursement). Teens and caregivers requested relatable, bilingual Latina facilitators. Organizational adoption was perceived as likely since the workshop addresses clients’ needs and fits with organizational values. Recommendations for sustainment included identifying funding opportunities specific to each organization. Conclusions: Our findings directly informed the refinement of intervention components and implementation strategies to be used in a pilot optimization trial of Floreciendo. This work highlights the invaluable role that implementation science can play in research informed by the MOST framework.StandUPTV : a full-factorial optimization trial to reduce sedentary screen time among adults
AbstractKeadle, S. K., Hasanaj, K., Leonard, K. S., Fernandez, A., Freid, L., Weiss, S., Legato, M., Anand, H., Hagobian, T. A., Phillips, S. M., Phelan, S., Guastaferro, K., Seltzer, R. G., & Buman, M. P. (n.d.).Publication year
2025Journal title
International Journal of Behavioral Nutrition and Physical ActivityVolume
22Issue
1AbstractBackground: Using the multiphase optimization strategy (MOST) framework, we aimed to identify an optimized mHealth-delivered intervention for reducing recreational sedentary screen time (rSST) by at least 60 min/day among adults. Methods: Eligible participants were 23–64 years old and self-reported elevated rSST (> 3 h/day). Following a 7-day baseline, participants received a core mHealth application (self-monitoring and 50% reduction target and educational materials) and were randomly assigned to three additional components set to on/off in a full-factorial (23) experiment: LOCKOUT: rSST electronically restricted; TEXT: rSST reduction prompts; and EARN: rSST through physical activity. rSST was assessed at baseline and 16 weeks via an integrated measure that included objectively assessed sedentary time (activPAL accelerometer) and screen time (TV Wifi plugs and tablet usage). We used a linear mixed effect model to evaluate the change in rSST for the three intervention components and their interactions. Results: A total of 82% of the randomized participants (N = 110) were female, with a mean ± SD age of 41 ± 11.7 y and a BMI of 29.7 ± 7.8 kg/m2, and their mean (95% CI) rSST was 184.7 (172.8, 196.5) min/day at baseline. The expected difference (baseline vs. 16 weeks) in rSST was greatest for the intervention versions with the core plus EARN on with an average reduction of -118.1 (-163.0, -73.1) min/day and for core plus LOCKOUT, TEXT, & EARN on (-125.7 [-172.0, -79.3] min/day). Conclusions: We identified several promising intervention versions that exceeded our optimization objective. This study provides important evidence on efficacious multicomponent interventions that should be moved forward to the evaluation phase of the MOST framework to test the effect of rSST reductions on health outcomes. Trial registration: (clinicaltrials.govThe ROOTS Parenting Intervention to Improve Child Emotional and Physical Health: Protocol For A Pilot Randomized Controlled Trial For Black And Latiné Families
AbstractCooper, D. K., Lupini, F., Alonzo, J., Beets, M., Guastaferro, K., McLain, A. C., Saini, S., & Prinz, R. (n.d.).Publication year
2025Journal title
Journal of Marital and Family TherapyVolume
51Issue
3AbstractBlack and Latiné children in the United States experience disproportionate rates of emotional and physical health problems, yet few preventive interventions address both types of outcomes in a culturally relevant way. This study explores the feasibility of a parenting program that incorporates ethnic-racial socialization and healthy lifestyle behaviors to promote the health of Black and Latiné children ages 3-6. A type 1 hybrid randomized controlled trial will be conducted with 60 families, who will be assigned to a parenting program or an active control condition, assessed at three time points. Feasibility measures will include quantitative and qualitative assessments of implementation outcomes and determinants. The main intervention outcomes are child social-emotional functioning, child healthy lifestyle behaviors, and parenting processes. Findings will inform future efforts to implement and scale culturally relevant parenting interventions aiming to improve the emotional and physical health of minoritized children. TRIAL REGISTRATION: The trial began recruiting in May 2024 (Trial Registry: NCT06111651, Version 5, June 13, 2024). Participants are expected to complete their 3-month follow-up assessments at the end of fall 2025.