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NCT Number: NCT06145451

Connected Through Coaching for Flourishing Families

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Maltreatment by Parent

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University, Cleveland, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Having a substantiated history of child maltreatment

Treatment and study plan

Family Success Network

Behavioral

The Family Success Network (FSN) is a community-based maltreatment prevention program that is being piloted to serve caregivers of children aged between 0-18 in the Trumbull, Mahoning, and Columbiana Counties in Ohio. FSN is a comprehensive multi-tier program providing information and referrals to community resources at Tier I (i.e., the initial contact stage), caregiver education, and financial literacy program along with concrete support at Tier II (i.e., enrollment in family coaching services in FSN), and a life skills program and monthly home visits for families with more intensive needs at tier III (most intensive level of FSN services).

Other names: FSN

Primary outcomes

  1. Protective factors

    Time frame: 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.

Secondary outcomes

  1. Relational Responsiveness

    Time frame: baseline vs. 3 month (at the time of service completion)

    Participant relational responsiveness (RR) will be assessed using the Working Alliance Inventory Short-Revised (WAI-SR), which is a 12-item, 5-point Likert scale with the response categories ranging from "Seldom" to "Always". WAI consists of three domains including agreement on goals, agreement on tasks, and bond between clients and providers. Instead of aggregating multiple items into a continuous variable, RR will be treated as a single order continuous latent construct with 3 distinct domains.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Case Western Reserve University
  • Centers for Disease Control and Prevention
  • Ohio State University

Registry information

Official study title

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

Acronym: CCFF

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 24, 2023
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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