Clinical trial NCT06074068: Father-Focused Intervention for Reducing Family Violence and Symptoms in Children
Official title: Examining Therapeutic Change Mechanisms in an Affect Regulation, Father-Focused Intervention for Reducing Family Violence and Associated Symptoms in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intimate Partner Violence
Child Maltreatment
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: University of Connecticut
name: University of Delaware
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-10-10
Enrollment: 1080
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* have at least one 6 month to 12-year-old biological child with whom they have contact;
* had an incident of IPV within the last 12 months prior to screening with their child's mother (based on court/police records, coparent or self-report);
* have a currently open or recently investigated (in the last 6 months) case with CT DCF
* are able to complete assessments in English;
* agree to have their female coparents (mother of target child) contacted as collateral informants and for consent for participation of their child. If a participant has more than one child in the age range, the youngest will be selected;
* female coparents (i.e., biological mother who need not be in a relationship with the father) consents to (at minimum) provide parent-report on child; however, may opt out of child participation. If the coparent agrees to participate by providing caregiver-report on child symptoms, but declines participation of their shared child, the father may still participate in the study if he meets eligibility criteria outlined below; thus, preventing any possible retaliation against co-parents for not consenting to child participation.

Exclusion Criteria:

Fathers will be excluded based on the following exclusion criteria:

* an active full/no contact protective order pertaining to their child because this will preclude participation in the father-child play assessment (many men will have protective orders pertaining to their partners, but it is more common for men to still be allowed contact with their children);
* physiological addiction to a substance that requires detoxification. Fathers will be evaluated using the Drug Abuse Screening Test and AUDIT. If fathers report significant difficulties with physiological withdrawal (e.g., alcohol tremors or dope sickness) they will be referred for detox services. They can be re-evaluated following a detox program with documentation from the detox center of successful completion and clean urine screen;
* cognitive impairment that will not allow for understanding of the study interventions (a mini mental state score \<25);
* current untreated psychotic disorder;
* currently suicidal or homicidal ideation based on screening using the BSI; or
* previously participated in F4C or a BIP.

Primary outcomes:
measure: Change in Physical Intimate Partner Violence (IPV) overtime
timeFrame: Baseline, 19 weeks, 43 weeks and 70 weeks
measure: Change in Verbal Intimate Partner Violence (IPV) overtime
timeFrame: Baseline, 19 weeks, 43 weeks and 70 weeks
measure: Change in Physical Child Maltreatment overtime
timeFrame: Baseline, 19 weeks, 43 weeks and 70 weeks
measure: Change in Verbal Child Maltreatment overtime
timeFrame: Baseline, 19 weeks, 43 weeks and 70 weeks
Secondary outcomes:
measure: Change in Child Posttraumatic Stress Symptoms overtime
timeFrame: Baseline, 19 weeks, 43 weeks and 70 weeks
measure: Change in Father-child interactions overtime
timeFrame: Baseline, 19 weeks, and 70 weeks
measure: Change in Coercive Controlling Intimate Partner Violence (IPV) overtime
timeFrame: Baseline, 19 weeks, 43 weeks and 70 weeks
measure: Change in Child Anxiety Symptoms
timeFrame: Baseline, 19 weeks, 43 weeks and 70 weeks
measure: Change in Child Depression Symptoms
timeFrame: Baseline, 19 weeks, 43 weeks and 70 weeks
measure: Change in Child Aggression Symptoms
timeFrame: Baseline, 19 weeks, 43 weeks and 70 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale
state: Connecticut
city: West Hartford
country: United States
facility: UCONN Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Carla S Stover, PhD
role: PRINCIPAL_INVESTIGATOR
References: