Intimate Partner ViolenceF4CNCT06074068
Father-Focused Intervention for Reducing Family Violence and Symptoms in Children
A study testing Fathers for Change and Duluth BIP in people with Intimate Partner Violence and Child Maltreatment, run by Yale University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence, Child Maltreatment
- What is being tested?
- Fathers for Change and Duluth BIP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jan 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Yale
New Haven, Connecticut, 06520
- Recruiting
UCONN Health Center
West Hartford, Connecticut, 06119
About this study
Official title: Examining Therapeutic Change Mechanisms in an Affect Regulation, Father-Focused Intervention for Reducing Family Violence and Associated Symptoms in Children
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:
- Is F4C more efficacious than standard BIP in reducing family violence and child mental health impairment?
- What are the trajectories of therapeutic change targets across interventions?
- 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.
Read the 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 3 months through 12 years) randomized to F4C (N=140) or the Duluth Model (N=140), 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.
- Conditions
- Intimate Partner Violence, Child Maltreatment
- Being tested
- Fathers for Change, Duluth BIP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fathers for ChangeBehavioural
18 week individual therapy focused on fathers' emotion regulation, reflective functioning and family communication.
Duluth BIPBehavioural
18 week individually delivered psychoeducation and CBT focused program focused on intimate partner violence
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Duluth BIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 19 weeks, 43 weeks and 70 weeks
Secondary outcomes (6)
Change in Child Posttraumatic Stress Symptoms overtime
The Child Trauma Symptom Checklist will be used to assess child PTSD symptoms. Each symptom item is rated according to its frequency of occurrence using a four point scale ranging from 0 ("never") to 3 ("often"). The PTSD total raw score is converted to a t-score based on measure norms with scores ranging from 0 to 100. Higher scores indicate greater severity of posttraumatic symptoms.
Measured: Baseline, 19 weeks, 43 weeks and 70 weeks
Change in Father-child interactions overtime
Child interactive behavior coding based on 15 minute play assessment coded for dyadic reciprocity, fluency, conflict and hostility. Scores are on a 1 to 4 point scale. An average score is generated for a range of 1 to 4. Higher scores indicate more of the coded behavior.
Measured: Baseline, 19 weeks, and 70 weeks
Change in Coercive Controlling Intimate Partner Violence (IPV) overtime
The Coercive Controlling 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 coercive controlling IPV.
Measured: Baseline, 19 weeks, 43 weeks and 70 weeks
Change in Child Anxiety Symptoms
The Child Trauma Symptom Checklist will be used to assess child Anxiety symptoms. Each symptom item is rated according to its frequency of occurrence using a four point scale ranging from 0 ("never") to 3 ("often"). The Anxiety subscale score is converted to a t-score based on measure norms with scores ranging from 0 to 100. Higher scores indicate greater severity of anxiety symptoms.
Measured: Baseline, 19 weeks, 43 weeks and 70 weeks
Change in Child Depression Symptoms
The Child Trauma Symptom Checklist will be used to assess child Depression symptoms. Each symptom item is rated according to its frequency of occurrence using a four point scale ranging from 0 ("never") to 3 ("often"). The depression subscale score is converted to a t-score based on measure norms with scores ranging from 0 to 100. Higher scores indicate greater severity of anxiety symptoms.
Measured: Baseline, 19 weeks, 43 weeks and 70 weeks
Change in Child Aggression Symptoms
The Child Trauma Symptom Checklist will be used to assess child aggression symptoms. Each symptom item is rated according to its frequency of occurrence using a four point scale ranging from 0 ("never") to 3 ("often"). The Aggression subscale score is converted to a t-score based on measure norms with scores ranging from 0 to 100. Higher scores indicate greater severity of aggression symptoms.
Measured: Baseline, 19 weeks, 43 weeks and 70 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start11 Jan 2024
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut, University of Delaware, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Carla S Stover, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074068
- Sponsor's protocol ID
- 2000026789_a
- Other IDs
- 1R01HD110583-01A1
- Acronym
- F4C
- Status last verified
- Apr 2026
- First submitted
- 31 Jul 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Therapeutic Change Mechanisms in an Affect Regulation, Father-Focused Intervention for Reducing Family Violence and Associated Symptoms in Children
- ClinicalTrials.gov ID
- NCT06074068
- Acronym / sponsor ID
- F4C / 2000026789_a
- Conditions
- Intimate Partner Violence, Child Maltreatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,080 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- University of Connecticut, University of Delaware, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is F4C more efficacious than standard BIP in reducing family violence and child mental health impairment?
- What are the trajectories of therapeutic change targets across interventions?
- 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 3 months through 12 years) randomized to F4C (N=140) or the Duluth Model (N=140), 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fathers for Change | Experimental | Behavioral: Fathers for ChangeDefining 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. |
| Duluth BIP | Active comparator | Behavioral: Duluth BIPThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fathers for Change18 week individual therapy focused on fathers' emotion regulation, reflective functioning and family communication. | Behavioural | Fathers for Change |
| Duluth BIP18 week individually delivered psychoeducation and CBT focused program focused on intimate partner violence | Behavioural | Duluth BIP |
Primary outcome
Change in Physical Intimate Partner Violence (IPV) overtime
Time frame: Baseline, 19 weeks, 43 weeks and 70 weeks
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.
Change in Verbal Intimate Partner Violence (IPV) overtime
Time frame: Baseline, 19 weeks, 43 weeks and 70 weeks
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.
Change in Physical Child Maltreatment overtime
Time frame: Baseline, 19 weeks, 43 weeks and 70 weeks
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.
Change in Verbal Child Maltreatment overtime
Time frame: Baseline, 19 weeks, 43 weeks and 70 weeks
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.
6 secondary outcomes
Change in Child Posttraumatic Stress Symptoms overtime
Time frame: Baseline, 19 weeks, 43 weeks and 70 weeks
Change in Father-child interactions overtime
Time frame: Baseline, 19 weeks, and 70 weeks
Change in Coercive Controlling Intimate Partner Violence (IPV) overtime
Time frame: Baseline, 19 weeks, 43 weeks and 70 weeks
Change in Child Anxiety Symptoms
Time frame: Baseline, 19 weeks, 43 weeks and 70 weeks
Change in Child Depression Symptoms
Time frame: Baseline, 19 weeks, 43 weeks and 70 weeks
Change in Child Aggression Symptoms
Time frame: Baseline, 19 weeks, 43 weeks and 70 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carla S Stover, PhD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fathers for Change and Duluth BIP in people with Intimate Partner Violence and Child Maltreatment, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carla S Stover, PhD (2037853486, carla.stover@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Intimate Partner Violence (IPV) overtime (time frame: Baseline, 19 weeks, 43 weeks and 70 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.