Early Test of an Innovative Child Maltreatment (CM) Prevention Strategy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Technology Enhanced Implementation Package, SafeCare.
- Who it may be relevant to
- Registry conditions: Parenting Intervention, Maltreatment, Prevention. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Test of an Innovative Implementation Strategy to Improve Reach, Quality, and Equity in Child Maltreatment Prevention
Overview
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.
Interventions
- 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.
Primary outcome measures
- SafeCare Sick or Injured Child Checklist [Time frame: From the enrollment to the end the Health module, ~6 weeks after starting Health module]
- Child Planned Activities Training Checklist [Time frame: From the enrollment to the end the Parent Child Interaction module, ~6 weeks after starting Parent Child module]
- SafeCare Home Observation Checklist [Time frame: From the enrollment to the end the Safety module, ~6 weeks after starting Safety module]
- Brief Child Abuse Potential Inventory [Time frame: Baseline, 3- and 6-month follow up]
- Children Services Involvement [Time frame: Baseline, 3- and 6-month follow up]
Secondary outcome measures (12)
- Parent-Child Conflict Tactics Scale [Time frame: Baseline, 3-month and 6-month follow up]
- Parenting Stress Inventory [Time frame: Baseline, 3-month and 6-month follow up]
- Brief Symptom Inventory [Time frame: Baseline, 3-month and 6-month follow up]
- Patient Health Questionnaire [Time frame: Baseline, 3-month and 6-month follow up]
- NIDA Quick Screen [Time frame: Baseline, 3-month and 6-month follow up]
- Social Provisions Scale [Time frame: Baseline, 3-month and 6-month follow up]
- Protective Factors Survey [Time frame: Baseline, 3-month and 6-month follow up]
- Family Resource Scale [Time frame: Baseline, 3-month and 6-month follow up]
- The Accountable Health Communities (AHC) Health-Related Social Needs (HRSN) Screening Tool [Time frame: Baseline, 3-month and 6-month follow up]
- Client Satisfaction Survey [Time frame: 3-month follow up]
- Client Cultural Competency Inventory [Time frame: 3-month follow up]
- Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure [Time frame: 3-month follow up]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06912685 · Pro00141218