Pilot Test of an Innovative Implementation Strategy to Improve Reach, Quality, and Equity in Child Maltreatment Prevention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 62
- 主要终点
- Children Services Involvement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Technology Enhanced Implementation Package (TEIP)
The TEIP group will also receive SafeCare and the SafeCare provider will use added guidance on when to use in person or virtual sessions. They will also get access to different support tools, like games or videos, that may be played during online sessions.
干预措施: SafeCare (Other)
SafeCare as Usual
Normal care is SafeCare, 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.
干预措施: SafeCare (Other)
Technology Enhanced Implementation Package (TEIP)
The TEIP group will also receive SafeCare and the SafeCare provider will use added guidance on when to use in person or virtual sessions. They will also get access to different support tools, like games or videos, that may be played during online sessions.
干预措施: Technology Enhanced Implementation Package (Other)
结局指标
主要结局
Children Services Involvement
时间窗: Baseline, 3- and 6-month follow up
Caregivers will self-report on their interactions with child services during the study period. They will answer questions regarding the number of child welfare referrals received, any child placement changes, and current case status.
SafeCare Sick or Injured Child Checklist
时间窗: From the enrollment to the end the Health module, ~6 weeks after starting Health module
As part of routine SafeCare delivery, providers assess caregiver scores on structured assessments that are part of the Child Health module. Assessments are conducted at the first and last session of this module and scores are recorded in the NSTRC Provider portal. Parents are presented with various health scenarios and respond with actions they would take during those scenarios. Scores represent the percentage of steps reported correctly across all scenarios.
Child Planned Activities Training Checklist
时间窗: From the enrollment to the end the Parent Child Interaction module, ~6 weeks after starting Parent Child module
As part of routine SafeCare delivery, providers assess caregiver scores on structured assessments that are part of the Parent-Child and Parent-Infant Interaction modules. Assessments are conducted at the first and last session of this module and scores are recorded scores in the NSTRC Provider portal. Providers rate parents on the number of interaction skills used during three different interactions with their child, with total scores representing the average percentage of skills used across the three interactions.
SafeCare Home Observation Checklist
时间窗: From the enrollment to the end the Safety module, ~6 weeks after starting Safety module
As part of routine SafeCare delivery, providers assess caregiver scores on structured assessments that are part of the Home Safety module. Assessments are conducted at the first and last session of this module and scores are recorded in the NSTRC Provider portal. Providers assess three commonly used rooms in the home and count the number of accessible safety hazards across all rooms.
Brief Child Abuse Potential Inventory
时间窗: Baseline, 3- and 6-month follow up
The BCAP is a 33-item caregiver self-report measure that assesses factors related to child abuse potential and underlying factors related to child abuse risk. The BCAP can be completed in less than 5 minutes, is made up of minimally intrusive items, and is written below a fourth grade reading level. It is a valid and reliable tool for assessing parenting risk.
次要结局
- Patient Health Questionnaire(Baseline, 3-month and 6-month follow up)
- NIDA Quick Screen(Baseline, 3-month and 6-month follow up)
- Social Provisions Scale(Baseline, 3-month and 6-month follow up)
- Protective Factors Survey(Baseline, 3-month and 6-month follow up)
- Family Resource Scale(Baseline, 3-month and 6-month follow up)
- The Accountable Health Communities (AHC) Health-Related Social Needs (HRSN) Screening Tool(Baseline, 3-month and 6-month follow up)
- Parent-Child Conflict Tactics Scale(Baseline, 3-month and 6-month follow up)
- Parenting Stress Inventory(Baseline, 3-month and 6-month follow up)
- Brief Symptom Inventory(Baseline, 3-month and 6-month follow up)
- Client Satisfaction Survey(3-month follow up)
- Client Cultural Competency Inventory(3-month follow up)
- Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure(3-month follow up)
研究者
Hannah Espeleta
Research Assistant Professor-Faculty
Medical University of South Carolina