Father-Focused Intervention for Reducing Family Violence and Symptoms in Children

NCT06074068 | Recruiting DMC

• 2 other identifiers: 2000026789_a1R01HD110583-01A1
• Study Type: interventional
• Target: 1,080
• Locations: 1 country
• Sites: 2

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. 1.Is F4C more efficacious than standard BIP in reducing family violence and child mental health impairment?
2. 2.What are the trajectories of therapeutic change targets across interventions?
3. 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.

Conditions

Intimate Partner Violence; Child Maltreatment

Outcome Measures

Primary Outcomes (4)

• Change in Physical Intimate Partner Violence (IPV) overtime

  The Physical Intimate Partner Violence Subscale of the Family Socialization Interview-Revised will be used to assess physical IPV. Items are coded on a 4-point scale for severity from 0 (none) to 4 (severe). Scores are averaged to achieve a total score with a range of 0 to 4. Higher scores indicate greater frequency and severity of Physical IPV.

  Baseline, 19 weeks, 43 weeks and 70 weeks

• Change in Verbal Intimate Partner Violence (IPV) overtime

  The Verbal Intimate Partner Violence Subscale of the Family Socialization Interview-Revised will be used to assess verbal IPV. Items are coded on a 4-point scale for severity from 0 (none) to 4 (severe). Scores are averaged to achieve a final score with a range of 0 to 4. Higher scores indicate greater frequency and severity of verbal IPV.

  Baseline, 19 weeks, 43 weeks and 70 weeks

• Change in Physical Child Maltreatment overtime

  Family Socialization Interview-Revised will be used to assess physical child maltreatment. The Physical scale will be used for this outcome. Items are ranked on 0-4 point scale from 0 (none) to 4 (severe) and averaged for a final score with a range of 0 to 4 with higher scores indicating greater frequency and severity of physical child maltreatment risk.

  Baseline, 19 weeks, 43 weeks and 70 weeks

• Change in Verbal Child Maltreatment overtime

  Family Socialization Interview-Revised will be used to assess physical child maltreatment. The verbal scale will be used for this outcome. Items are ranked on 0-4 point scale from 0 (none) to 4 (severe) and averaged for a final score with a range of 0 to 4 with higher scores indicating greater frequency and severity of verbal child maltreatment risk.

  Baseline, 19 weeks, 43 weeks and 70 weeks

Secondary Outcomes (6)

• Change in Child Posttraumatic Stress Symptoms overtime

  Baseline, 19 weeks, 43 weeks and 70 weeks

• Change in Father-child interactions overtime

  Baseline, 19 weeks, and 70 weeks

• Change in Coercive Controlling Intimate Partner Violence (IPV) overtime

  Baseline, 19 weeks, 43 weeks and 70 weeks

• Change in Child Anxiety Symptoms

  Baseline, 19 weeks, 43 weeks and 70 weeks

• Change in Child Depression Symptoms

  Baseline, 19 weeks, 43 weeks and 70 weeks

Study Arms (2)

Fathers for Change

EXPERIMENTAL

Defining features of F4C include: 1) focus on the fathering role to facilitate engagement, 2) focus on RF to understand self, partner and children and emotion regulation skills to reduce IPV and child maltreatment. F4C focuses on understanding of emotional experiences, how they impact thinking and behaviors related to partners, co-parents and children. F4C clients will meet individually with their F4C therapist for 60 minutes per week over 18 weeks.

Behavioral: Fathers for Change

Duluth BIP

ACTIVE COMPARATOR

The BIP is a psychoeducational intervention that will be delivered in 60- minute individual weekly sessions over 18 weeks. The intervention focuses on the impact of violence on victims, power and control tactics, and societal influences supporting men's violence toward women. The intervention includes didactics and experiential exercises including video vignettes and role plays to teach anger management skills.

Behavioral: Duluth BIP

Interventions

Fathers for Change BEHAVIORAL

18 week individual therapy focused on fathers' emotion regulation, reflective functioning and family communication.

Fathers for Change

Duluth BIP BEHAVIORAL

18 week individually delivered psychoeducation and CBT focused program focused on intimate partner violence

Duluth BIP

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Primary participants identify as fathers. They will be targets of provided interventions. Coparents and children may be of any gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 or Spanish;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• University of Connecticut: collaborator
• University of Delaware: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Yale

New Haven, Connecticut, 06520, United States

RECRUITING

UCONN Health Center

West Hartford, Connecticut, 06119, United States

RECRUITING

Study Officials

• Carla S Stover, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla S Stover, PhD

CONTACT

2037853486; carla.stover@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: October 10, 2023
• Study Start: January 11, 2024
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)