Connected Through Coaching for Flourishing Families

NCT ID: NCT06145451

Last Updated: 2025-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

612 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-16

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Maltreatment by Parent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

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

Study Groups

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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.

Group Type EXPERIMENTAL

Family Success Network

Intervention Type 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).

Waitlist Control Group

Families in the Control Group will not receive any FSN services except concrete support of upto $500.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

Other Intervention Names

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FSN

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ohio State University

OTHER

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Deborah Moon

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deborah Moon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Collaborative fidelity assessment planning for the evaluation of a community-based maltreatment prevention model: The family success network (FSN) D. J. Moon, M. Johnson-Motoyama, C. Bailey Nichols, N. Rolock, H. Haran and R. Bai Children and Youth Services Review 2022 Vol. 137 Pages 106457 DOI: https://doi.org/10.1016/j.childyouth.2022.106457

Reference Type BACKGROUND

Johnson-Motoyama M, Moon D, Rolock N, Crampton D, Nichols CB, Haran H, Zhang Y, Motoyama Y, Gonzalez E, Sillaman N. Social Determinants of Health and Child Maltreatment Prevention: The Family Success Network Pilot. Int J Environ Res Public Health. 2022 Nov 21;19(22):15386. doi: 10.3390/ijerph192215386.

Reference Type BACKGROUND
PMID: 36430105 (View on PubMed)

Other Identifiers

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1 K01CE003543-01-00

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1K01CE003543-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY23110074

Identifier Type: -

Identifier Source: org_study_id

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