Clinical trial NCT06145451: Connected Through Coaching for Flourishing Families
Official title: Caregiver Relational Responsiveness (RR): an Understudied Fidelity Construct As a Mechanism to Increase Protective Factors Against Maltreatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maltreatment by Parent
Keywords: maltreatment prevention, relational responsiveness
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Ohio State University
name: Case Western Reserve University
name: Centers for Disease Control and Prevention
First posted: 2023-11-24
Enrollment: 612
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Protective factors
timeFrame: baseline vs. 3 month (at the time of service completion)
Secondary outcomes:
measure: Relational Responsiveness
timeFrame: baseline vs. 3 month (at the time of service completion)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Deborah Moon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.