Intimate Partner ViolenceNCT04165291

Comparing a Fatherhood Focused Individual Intervention to Batterer Intervention to Reduce IPV and Child Maltreatment

A study testing F4C and BIP in people with Intimate Partner Violence, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This randomized trial will test a newly developed intervention aimed at fathers who have a history of family violence compared to a standard batterer intervention program. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Intimate Partner Violence
What is being tested?: F4C and BIP
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2020to 30 Aug 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

A reported an incident of IPV (pushing, slapping, kicking) within the last 12 months prior to screening (based on court/police records, partner or self- report);
have at least one biological child aged 6 months to 7 years with whom they have contact in person or by phone/facetime etc. at least monthly;
are able to complete assessments in English;
agree to have their female coparents (mother of the youngest child) contacted as collateral informants and for consent for participation of their shared child.

Who cannot join

Men who have an active full/no contact protective order pertaining to their child since this will preclude participation in the father-child play assessment (many men will have full no-contact orders with their partners, but it is more common for men to still be allowed at least supervised contact with their children even with a full/no contact order with their partner);
physiological addiction to a substance that requires detoxification. Fathers will be evaluated using the Addiction Severity Index and urine toxicology screens. If fathers report difficulties with physiological withdrawal from substances (e.g. delirium tremens, shaking, nausea) 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.;
anyone with a cognitive impairment that will not allow for understanding of the study interventions (a mini mental state score <25);
anyone with a current untreated psychotic disorder;
anyone currently suicidal or homicidal based on screening using the BSI.

Trial locations and contacts

1 site in 1 country.

United States1 site

Carla Stover
Hamden, Connecticut, 06514

Other trials in United States

About this study

This randomized trial will test a newly developed intervention aimed at fathers who have a history of family violence compared to a standard batterer intervention program.

Read the detailed description

This study will expand on Fathers for Change (F4C), a novel intervention for fathers with histories of perpetrating intimate partner violence (IPV). F4C is designed to meet a significant unmet intervention need for fathers who have a history of family violence who are not helped by currently available batterer intervention programs (BIPs). BIPs that are currently available nationally have shown limited efficacy with high rates of repeat violence.

This project will provide needed data to further develop F4C and move to a Stage II efficacy trial by: 1) revising the BIP group intervention manual to be delivered in an individual treatment format; 2) develop a fidelity measure for F4C and the BIP; 4) conduct a stage 1b randomized trial (consistent with the stage model of intervention development) to show initial feasibility, acceptability and intervention signal with the targeted population.

Sixty fathers with a history of IPV who have already failed a treatment as usual group BIP will be randomly assigned to F4C or an individually delivered comparable dose of BIP. Reflective functioning and emotion regulation will be examined as the mechanisms through which Fathers for Change reduces IPV and child maltreatment risk behaviors.

Conditions: Intimate Partner Violence
Being tested: F4C, BIP

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

F4CBehavioural
Fathers for Change (F4C) focuses on: 1) the fathering role to facilitate engagement, 2) 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 50 minutes per week over 16 weeks.
BIPBehavioural
The Batterer Intervention Program (BIP) is a psychoeducational intervention that will be delivered in 50- minute individual weekly sessions over 16 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 role plays to teach anger management skills.

Study groups in NCT04165291
Study group	Role	What they receive
F4C	Experimental	Participants randomized to the Fathers for Change (F4C) program. Receives: Behavioral: F4C
BIP	Active comparator	Participants randomized to the Batterer Intervention Program (BIP). Receives: Behavioral: BIP

What is being measured

The primary outcome is the main question the study is designed to answer.

Completion Rate
To test the hypothesis that fathers randomized to F4C will have higher completion rates than those in the individual BIP treatment, chi-square analysis will be used to examine between group differences in treatment completion.
Measured: 18 weeks
Working Alliance Inventory Sum Score
To test the hypothesis that fathers randomized to F4C will report greater overall working alliance, analysis of variance will be used to test between group difference in overall working alliance between F4C and BIP at week 8 of intervention (approximately mid-point). The Working Alliance Inventory (WAI-therapist version) will be used to measure working alliance among clinicians and clients. The WAI for therapists measures the strength of the working alliance with the client with 36 items utilizing a 5-point Likert scale. The minimum score is 0, the maximum score is 180. Higher sum score indicates a stronger working alliance.
Measured: 8 weeks
Client Satisfaction Sum Score
To test the hypothesis that fathers randomized to F4C will report greater overall satisfaction, analysis of variance will be used to test between group difference in overall client satisfaction between F4C and BIP. Satisfaction scores range from 2 to 8 with 8 indicating greater overall satisfaction with the services received.
Measured: 18 weeks

Secondary outcomes (4)

Reflective Functioning
Reflective functioning will be assessed using the Parent Development Interview-Revised (PDI). The PDI is a 40-item semi-structured interview that assesses reflective functioning through questions about child-rearing and the ways respondents are like or unlike their own parents. Interviews will be audio recorded and transcribed verbatim for scoring. Interviews are coded on a scale of 1 to 9 with 1 being poor and 9 being excellent reflective functioning. A score of 3 or less is considered very poor.
Measured: Baseline and 18 weeks
Emotional Regulation
Emotional regulation will be assessed with the Difficulties in Emotion Regulation Scale-short form (DERS-SF). The DERS-SF is an 18-item self-report measure scored on a 5-point Likert-type scale where higher scores indicate greater difficulty in emotional regulation. Scores range from 18-90.
Measured: Baseline and 18 weeks
Intimate Partner Violence
The TimeLine Follow-back-Spousal Violence will be used to characterize the frequency of intimate partner violence.
Measured: 18 weeks
Child Maltreatment
Child maltreatment risk will be assessed using TimeLine Follow-back to assess the frequency of behaviors characterized as child maltreatment.
Measured: 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202030 Aug 2023

First posted15 Nov 2019
Study start1 Sep 2020
Primary completion30 Jul 2023
Study completion30 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04165291
Sponsor's protocol ID: 2000026789
Other IDs: 1R21HD099318-01A1
Status last verified: Mar 2024
First submitted: 14 Nov 2019
Last updated: 4 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veterans
Alcohol Problems, Post-Traumatic Stress Disorder
Recruiting
Adjunctive Motivational Alcohol Intervention to Prevent IPV
Alcohol Use and Intimate Partner Violence
Recruiting
SER Familia: A Family-Based Intervention Addressing Syndemic Conditions Among Latino Families
Substance Abuse, Intimate Partner Violence (IPV)
Recruiting
RISE Versus Advocacy-based Enhanced Care as Usual for Patients Experiencing IPV
Intimate Partner Violence (IPV)
Not yet recruiting
Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders
Intimate Partner Violence, Personality Disorders

All Intimate Partner Violence trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparing a Fatherhood Focused Individual Intervention to Batterer Intervention to Reduce IPV and Child Maltreatment
ClinicalTrials.gov ID: NCT04165291
Acronym / sponsor ID: 2000026789
Conditions: Intimate Partner Violence
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 1 Sep 2020 (actual)
Primary completion: 30 Jul 2023 (actual)
Study completion: 30 Aug 2023 (actual)
First posted: 15 Nov 2019 (actual)
Results: Posted 4 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This randomized trial will test a newly developed intervention aimed at fathers who have a history of family violence compared to a standard batterer intervention program.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
F4C	Experimental	Behavioral: F4CParticipants randomized to the Fathers for Change (F4C) program.
BIP	Active comparator	Behavioral: BIPParticipants randomized to the Batterer Intervention Program (BIP).

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

A reported an incident of IPV (pushing, slapping, kicking) within the last 12 months prior to screening (based on court/police records, partner or self- report);
have at least one biological child aged 6 months to 7 years with whom they have contact in person or by phone/facetime etc. at least monthly;
are able to complete assessments in English;
agree to have their female coparents (mother of the youngest child) contacted as collateral informants and for consent for participation of their shared child.

Key exclusion criteria (5 listed)

Men who have an active full/no contact protective order pertaining to their child since this will preclude participation in the father-child play assessment (many men will have full no-contact orders with their partners, but it is more common for men to still be allowed at least supervised contact with their children even with a full/no contact order with their partner);
physiological addiction to a substance that requires detoxification. Fathers will be evaluated using the Addiction Severity Index and urine toxicology screens. If fathers report difficulties with physiological withdrawal from substances (e.g. delirium tremens, shaking, nausea) 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.;
anyone with a cognitive impairment that will not allow for understanding of the study interventions (a mini mental state score <25);
anyone with a current untreated psychotic disorder;
anyone currently suicidal or homicidal based on screening using the BSI.

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
F4CFathers for Change (F4C) focuses on: 1) the fathering role to facilitate engagement, 2) 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 50 minutes per week over 16 weeks.	Behavioural	F4C
BIPThe Batterer Intervention Program (BIP) is a psychoeducational intervention that will be delivered in 50- minute individual weekly sessions over 16 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 role plays to teach anger management skills.	Behavioural	BIP

Primary outcome

Completion Rate
Time frame: 18 weeks
To test the hypothesis that fathers randomized to F4C will have higher completion rates than those in the individual BIP treatment, chi-square analysis will be used to examine between group differences in treatment completion.
Working Alliance Inventory Sum Score
Time frame: 8 weeks
To test the hypothesis that fathers randomized to F4C will report greater overall working alliance, analysis of variance will be used to test between group difference in overall working alliance between F4C and BIP at week 8 of intervention (approximately mid-point). The Working Alliance Inventory (WAI-therapist version) will be used to measure working alliance among clinicians and clients. The WAI for therapists measures the strength of the working alliance with the client with 36 items utilizing a 5-point Likert scale. The minimum score is 0, the maximum score is 180. Higher sum score indicates a stronger working alliance.
Client Satisfaction Sum Score
Time frame: 18 weeks
To test the hypothesis that fathers randomized to F4C will report greater overall satisfaction, analysis of variance will be used to test between group difference in overall client satisfaction between F4C and BIP. Satisfaction scores range from 2 to 8 with 8 indicating greater overall satisfaction with the services received.

4 secondary outcomes

Reflective Functioning
Time frame: Baseline and 18 weeks
Emotional Regulation
Time frame: Baseline and 18 weeks
Intimate Partner Violence
Time frame: 18 weeks
Child Maltreatment
Time frame: 18 weeks

Results and safety

Results posted to the registry on 4 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fathers for Change	30	20
Duluth Domestic Violence Program (BIP)	30	21

Primary outcome: Completion Rate

Time frame: 18 weeks. Count of participants. Unit: Participants

Measure	Fathers for Change n = 30	Duluth Domestic Violence Program (BIP) n = 30
Value	20	21

Primary outcome: Working Alliance Inventory Sum Score

Time frame: 8 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Fathers for Change n = 25	Duluth Domestic Violence Program (BIP) n = 23
Value	62.52 (8.96)	55.82 (6.77)

Fathers for Change vs Duluth Domestic Violence Program (BIP): p <.01, ANOVA

Population analysed: Working Alliance was measured at 8 weeks from start of the interventions.

Primary outcome: Client Satisfaction Sum Score

Time frame: 18 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Fathers for Change n = 24	Duluth Domestic Violence Program (BIP) n = 18
Value	7.75 (.68)	7.33 (.84)

Fathers for Change vs Duluth Domestic Violence Program (BIP): p = .08, ANOVA

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 19 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fathers for Change	3 of 30 (10%)	3 of 30 (10%)	0 of 30
Duluth Domestic Violence Program (BIP)	1 of 30 (3.3%)	1 of 30 (3.3%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Intimate Partner Violence

Not yet recruiting
The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veterans
Alcohol Problems, Post-Traumatic Stress Disorder
Recruiting
Adjunctive Motivational Alcohol Intervention to Prevent IPV
Alcohol Use and Intimate Partner Violence
Recruiting
SER Familia: A Family-Based Intervention Addressing Syndemic Conditions Among Latino Families
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Recruiting
RISE Versus Advocacy-based Enhanced Care as Usual for Patients Experiencing IPV
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Not yet recruiting
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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. This study is not recruiting at the moment.

Carla Stover, PhD principal investigator

Associate Professor at the Yale University School of Medicine Child Study Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing F4C and BIP in people with Intimate Partner Violence, run by Yale University at 1 site 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 4 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion Rate (time frame: 18 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04165291.

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 4 Apr 2024.