Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2025-12-29 @ 4:31 AM
Study NCT ID:
NCT06074068
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2023-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Father-Focused Intervention for Reducing Family Violence and Symptoms in Children
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Examining Therapeutic Change Mechanisms in an Affect Regulation, Father-Focused Intervention for Reducing Family Violence and Associated Symptoms in Children
Status:
RECRUITING
Status Verified Date:
2025-07
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:
F4C
Brief Summary:
The goal of this clinical trial is to test the efficacy of Fathers for Change (F4C) compared to standard Batterer Intervention for fathers with a history of Intimate Partner Violence. The main question\[s\] it aims to answer are:
1. Is F4C more efficacious than standard BIP in reducing family violence and child mental health impairment?
2. What are the trajectories of therapeutic change targets across interventions?
3. Does father's emotion regulation and reflective functioning mediate the relationship between the two interventions and child-related outcomes? Participants will be randomized to either Fathers for Change on Batterer Intervention.
1. Is F4C more efficacious than standard BIP in reducing family violence and child mental health impairment?
2. What are the trajectories of therapeutic change targets across interventions?
3. Does father's emotion regulation and reflective functioning mediate the relationship between the two interventions and child-related outcomes? Participants will be randomized to either Fathers for Change on Batterer Intervention.
Detailed Description:
Children's exposure to intimate partner violence (IPV), often perpetrated by fathers, has been described as a gateway to other adversity, with more than a 50% co-occurrence of direct forms of child maltreatment (CM). IPV exposure can wreak havoc on children, with risk for psychosocial impairments, including posttraumatic stress disorder (PTSD), that can emerge early and cascade across development. Lacking are interventions that adequately address the complex nature of IPV in families, including fatherhood and coparenting. This gap reflects a bias towards excluding offending fathers from child-focused work and an overreliance on batterer intervention programs (BIPs), which have shown negligible effects in meta-analyses and fail to address the roots of offending behaviors in fathers. Consequently, IPV exposed children remain at risk and fathers' personal and interpersonal functioning, including the father-child relationship, does not improve. In effect, there is an urgent need for effective interventions for fathers and their families. Fathers for Change (F4C) is a novel fatherhood-focused intervention with a dual focus on IPV and CM that focuses on identifying, understanding, and managing emotions to reduce aggression and improve partner and parent-child interactions. F4C has a growing evidence-base demonstrating significant reductions in family violence, improved father-child interactions, and in one open trial, improved child mental health. Proposed therapeutic mechanisms of F4C include reflective functioning (RF), the capacity for parents to understand their own and children's actions as a function of underlying states and motivations, and emotion regulation (ER), the capacity to exert control over emotional states and reactions to threat. Poor RF and ER have been associated with increased family violence and stress-related psychopathology, suggesting key focal points for intervention. To date, there have been no empirical examinations of ER and RF as therapeutic change mechanisms for reducing family violence and improving father-child interactions and child mental health. Proposed is a dual-site, multi-modal examination of ER and RF in fathers (of children 4-7 y.o.) randomized to F4C (N=180) or the Duluth Model (N=180), a BIP serving as active control. In-session observational coding will assess adaptive and maladaptive ER and RF across treatment. Weekly self-ratings will assess at-home ER and RF. Aims will (1) assess efficacy of F4C compared to a standard BIP in reducing family violence and child mental health impairment, (2) map and compare trajectories of therapeutic change targets across interventions, and (3) examine the mediating role of father's ER and RF on child-related outcomes. This proposal will grow the evidence-base for F4C and advance our understanding of therapeutic mechanisms through which F4C exerts its effects.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01HD110583-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |