Connected Through Coaching for Flourishing Families (CCFF)

October 28, 2025 updated by: Deborah Moon, University of Pittsburgh

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

612

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
The Family Success Network is a multi-tier, multi-component community-based maltreatment prevention program that offers tailored preventive services for caregivers of children aged 0-18. Average lengths of service completion is approximately 3 months.
Behavioral: Family Success Network
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
No Intervention: Waitlist Control Group
Families in the Control Group will not receive any FSN services except concrete support of upto $500.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline vs. 3 month (at the time of service completion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline vs. 3 month (at the time of service completion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

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

Investigators

  • Principal Investigator: Deborah Moon, PhD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2024

Primary Completion (Actual)

September 15, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 17, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Actual)

November 24, 2023

Study Record Updates

Last Update Posted (Estimated)

October 30, 2025

Last Update Submitted That Met QC Criteria

October 28, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY23110074
  • 1 K01CE003543-01-00 (Other Grant/Funding Number: Centers for Disease Control and Prevention)
  • 1K01CE003543-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified qualitative data may be shared upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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