跳至主要内容
临床试验/NCT06145451
NCT06145451进行中(未招募)不适用

Caregiver Relational Responsiveness (RR): An Understudied Fidelity Construct as a Mechanism to Increase Protective Factors Against Maltreatment

University of Pittsburgh6 个研究点 分布在 1 个国家目标入组 612 人开始时间: 2024年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
612
试验地点
6
主要终点
Protective factors

研究概览

简要总结

Despite the known association between the quality of participant relational engagement with service providers and clinical outcomes, limited studies have examined caregiver Relational Responsiveness (RR) as a mechanism to achieve maltreatment prevention program outcomes. Using a realist-informed mixed method approach, this study will examine RR's role in mediating the effects of a community-based maltreatment prevention program, the Family Success Network (FSN) on protective factors against maltreatment and the contexts within which RR's mediation effects are activated or inhibited.

详细描述

Maltreatment prevention programs can promote public health by building protective factors among at-risk families. To maximize their benefits, programs should be delivered as intended by maintaining fidelity. Participant responsiveness (PR) is an under-studied fidelity construct defined as the degree to which participants "respond to or are engaged by" intervention at the behavioral, attitudinal, and relational levels. However, previous studies mostly focus on behavioral and attitudinal responsiveness such as attendance, follow-through, and satisfaction. The purpose of this study is to examine the role of participant Relational Responsiveness (RR) as a mechanism to increase protective factors against child maltreatment among the caregivers participating in the Family Success Network (FSN). The FSN is a community-based maltreatment prevention program piloted to serve 3 under-served counties in Ohio with high maltreatment rates. In FSN, coaches and families collaboratively develop a tailored plan of services designed to increase family protective factors. Focusing on primary and secondary prevention, FSN serves families with no history of substantiated maltreatment. Leveraging the parent study (clinicatrials registration currently in progress), which is a Randomized Controlled Trial (RCT) funded by the Children's Bureau, the proposed study will pursue the following aims; 1) To examine the structural validity of the Relational Responsiveness (RR) measure among FSN participants; 2) To determine the degree to which RR mediates FSN effects and whether RR's mediation effects are moderated by caregiver race and gender; 3) To identify contexts within which RR's mediation effects are activated or inhibited using a realist informed mixed-method approach. The parent study focuses on FSN outcome and process evaluations. Aims 1 and 2 of this study will utilize quantitative data collected through the parent RCT (protective factors and Working Alliance Inventory-Short Revised). Aim 3 will use mixed data involving the quantitative data collected through the parent RCT and the qualitative data to be collected in this study.

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
Single (Investigator)

盲法说明

Researchers have no direct contact with research participants as all data collection activities are carried out by care providers.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being an adult primary caregiver living in the tri-county area
  • Having at least one child aged between 0-17
  • Reporting at least one maltreatment risk factor at the time of intake
  • Receiving family coaching services at Tier II and above in FSN.

排除标准

  • Having a substantiated history of child maltreatment

结局指标

主要结局

Protective factors

时间窗: baseline vs. 3 month (at the time of service completion)

The family protective factors will be assessed using the Protective Factors Survey - Second Edition (PFS-2). It is a 19-item, 5-point Likert scale assessing 1) Family Functioning/Resilience \[family's adaptive skills and strategies to persevere in times of crisis, 3 items, subscale score of 0-3\], 2) Nurturing/Attachment \[emotional bond and positive parent-child interactions, 4 items, subscale score of 0-4\]; 3) Concrete Supports \[perceived access to tangible goods and services, 2 items, subscale score of 0-8\]; 4) Social Supports \[4 items, subscale score of 0-16 plus the number of items checked in the social support checklist, which ranges between 0-4\]. Except for the concrete support subscale in which higher scores indicate lower level of concrete support, higher scores indicate higher level of assessed qualities in all the other subscales.

次要结局

  • Relational Responsiveness(baseline vs. 3 month (at the time of service completion))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Deborah Moon

Associate Professor

University of Pittsburgh

研究点 (6)

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