Viewing Study NCT06145451



Ignite Creation Date: 2024-05-06 @ 7:49 PM
Last Modification Date: 2024-10-26 @ 3:14 PM
Study NCT ID: NCT06145451
Status: RECRUITING
Last Update Posted: 2024-07-03
First Post: 2023-11-17

Brief Title: Connected Through Coaching for Flourishing Families
Sponsor: University of Pittsburgh
Organization: University of Pittsburgh

Study Overview

Official Title: Caregiver Relational Responsiveness RR an Understudied Fidelity Construct As a Mechanism to Increase Protective Factors Against Maltreatment
Status: RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CCFF
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 RRs 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 RRs 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 Childrens 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 RRs mediation effects are moderated by caregiver race and gender 3 To identify contexts within which RRs 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1 K01CE003543-01-00 OTHER_GRANT Centers for Disease Control and Prevention None