Clinical trial NCT06912685: Pilot Test of Innovative Child Maltreatment (CM) Prevention Strategy
Official title: Pilot Test of an Innovative Implementation Strategy to Improve Reach, Quality, and Equity in Child Maltreatment Prevention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parenting Intervention
Maltreatment
Prevention
Keywords: Disease Prevention
Healthy Volunteer Studies
Infant
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2025-04-06
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* English language proficiency
* Ability to provide informed consent for themselves
* Has at least one child between the ages of 0-5 years old - Caregivers Only
* Has completed at least 1 module of SafeCare since April 2021 - Caregivers Only
* SafeCare enrollment has been completed (e.g., not currently enrolled in SafeCare). - Caregivers Only
* Current employment at a SafeCare agency - Agency Leaders Only
* Full- or part-time employment at a SafeCare agency - Providers Only
* Must be fully certified to provide SafeCare services - Providers Only
* Must be providing services for at least 6 months - Providers Only

Exclusion Criteria:

* Evidence of significant cognitive disability, developmental delay, or pervasive developmental disorder that would prohibit capacity to consent for themselves - Caregivers Only
* There are no primary exclusion criteria for the Providers.
* There are no primary exclusion criteria for Agency Leaders.

Primary outcomes:
measure: SafeCare Sick or Injured Child Checklist
timeFrame: From the enrollment to the end the Health module, ~6 weeks after starting Health module
measure: Child Planned Activities Training Checklist
timeFrame: From the enrollment to the end the Parent Child Interaction module, ~6 weeks after starting Parent Child module
measure: SafeCare Home Observation Checklist
timeFrame: From the enrollment to the end the Safety module, ~6 weeks after starting Safety module
measure: Brief Child Abuse Potential Inventory
timeFrame: Baseline, 3- and 6-month follow up
measure: Children Services Involvement
timeFrame: Baseline, 3- and 6-month follow up
Secondary outcomes:
measure: Parent-Child Conflict Tactics Scale
timeFrame: Baseline, 3-month and 6-month follow up
measure: Parenting Stress Inventory
timeFrame: Baseline, 3-month and 6-month follow up
measure: Brief Symptom Inventory
timeFrame: Baseline, 3-month and 6-month follow up
measure: Patient Health Questionnaire
timeFrame: Baseline, 3-month and 6-month follow up
measure: NIDA Quick Screen
timeFrame: Baseline, 3-month and 6-month follow up
measure: Social Provisions Scale
timeFrame: Baseline, 3-month and 6-month follow up
measure: Protective Factors Survey
timeFrame: Baseline, 3-month and 6-month follow up
measure: Family Resource Scale
timeFrame: Baseline, 3-month and 6-month follow up
measure: The Accountable Health Communities (AHC) Health-Related Social Needs (HRSN) Screening Tool
timeFrame: Baseline, 3-month and 6-month follow up
measure: Client Satisfaction Survey
timeFrame: 3-month follow up
measure: Client Cultural Competency Inventory
timeFrame: 3-month follow up
measure: Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure
timeFrame: 3-month follow up
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Hannah Espeleta
role: PRINCIPAL_INVESTIGATOR
References: