NCT06912685

Pilot Test of Innovative Child Maltreatment (CM) Prevention Strategy

Pilot Test of an Innovative Implementation Strategy to Improve Reach, Quality, and Equity in Child Maltreatment Prevention

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Millions of children are victims of maltreatment each year in the United States. Research on home visiting programs show that child maltreatment can be prevented; however, these programs struggle to reach families in need and provide high quality care. SafeCare is a sustainable and effective home visiting child maltreatment prevention program, serving over 8,000 families each year. This study will examine the feasibility and implementation of a hybrid in-person/virtual delivery model for SafeCare with 12 home visiting providers and 40 caregivers to inform how home visiting programs are delivered to maximize reach to families, improve family outcomes, and decrease harm to children.

Detailed description

Child maltreatment (CM) is a public health priority, affecting millions of children each year. Evidence-based home visiting (HV) models are gold standard CM prevention programs that intervene on modifiable risk factors. Despite their effectiveness and national implementation, HV is resource intensive which limits their potential reach and impact. HV programs serve only 3% of high-risk families, with limited access for minoritized and rural-dwelling families. Rigorous research is needed to guide approaches to implementing HV to ensure agencies can deliver the highest-quality care with more accessibility and equity without compromising child safety. Preliminary data during the COVID-19 pandemic offered insight to the benefits of virtual, telehealth-based visits for CM prevention and enabled service agencies to observe that quality and safety concerns can be managed in most cases. The consensus of experts and HV providers is that hybrid, telehealth leveraged HV implementation can enhance access, quality, and efficiency of CM prevention models. Moreover, technology-based supports are needed to engage families, drive skill acquisition, support model fidelity, and improve accuracy in safety and skill assessment. Through an institutional KL2 award (PI: Espeleta), leveraging community advisory boards, secondary data analysis of clinical services data, and user-centered design methods, I am developing a telehealth-compatible, technology-enhanced, hybrid in-person/virtual implementation package for CM prevention. This package will consist of protocol adaptations, evidence-informed guidelines, and digital health resources to improve implementation outcomes related to reach, quality, and equity. However, the KL2 does not include a pilot RCT, which is essential to establish the feasibility of the implementation package as well as the RCT methodology in preparation for a future R01. The project's goals are to 1) Refine and preliminarily evaluate the TEIP and the feasibility of the research methodology with 12 providers and 40 families; and 2) Assess implementation factors related to the TEIP including its usability, acceptability, and feasibility with key constituents. Findings will inform a future R01 submission to evaluate the hybrid HV/virtual implementation on dimensions of equitable reach, effectiveness, implementation, and maintenance.

Conditions

• Parenting Intervention
• Maltreatment
• Prevention

Interventions

Type	Name	Description
OTHER	Technology Enhanced Implementation Package	The Technology Enhanced Implementation Package for SafeCare delivery consists of protocol adaptations, evidence-informed guidelines, and digital health resources to improve SafeCare outcomes related to reach, quality, and equity.
OTHER	SafeCare	SafeCare is an evidence-based home visiting parenting program with three modules focused on child health, home safety, and parent-child relationships. SafeCare sessions typically occur weekly over 18 weeks.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-10-01
• Completion: 2028-01-01
• First posted: 2025-04-06
• Last updated: 2025-09-02