NCT06145451

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
612

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Aug 2024

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Aug 2024Sep 2026

First Submitted

Initial submission to the registry

November 17, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

August 16, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

October 30, 2025

Status Verified

October 1, 2025

Enrollment Period

1.1 years

First QC Date

November 17, 2023

Last Update Submit

October 28, 2025

Conditions

Keywords

maltreatment prevention, relational responsiveness

Outcome Measures

Primary Outcomes (1)

  • Protective factors

    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 Outcomes (1)

  • Relational Responsiveness

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

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Waitlist Control Group

NO INTERVENTION

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

Interventions

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).

Also known as: FSN
Treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Having a substantiated history of child maltreatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (2)

  • 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

    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.

    PMID: 36430105BACKGROUND

Study Officials

  • Deborah Moon, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Researchers have no direct contact with research participants as all data collection activities are carried out by care providers.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 17, 2023

First Posted

November 24, 2023

Study Start

August 16, 2024

Primary Completion

September 15, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

October 30, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

De-identified qualitative data may be shared upon request.

Locations