Trial Outcomes & Findings for Comparing a Fatherhood Focused Individual Intervention to Batterer Intervention to Reduce IPV and Child Maltreatment (NCT NCT04165291)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

18 weeks

Results posted on

2024-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	Fathers for Change Participants randomized to the Fathers for Change (F4C) program. F4C: 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 18 weeks.	Duluth Domestic Violence Program (BIP) Participants randomized to the Batterer Intervention Program (BIP). BIP: The Batterer Intervention Program (BIP) is a psychoeducational intervention that will be delivered in 50- 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 role plays to teach anger management skills.
Overall Study STARTED	30	30
Overall Study COMPLETED	20	21
Overall Study NOT COMPLETED	10	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fathers for Change n=30 Participants Participants randomized to the Fathers for Change (F4C) program. F4C: 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 18 weeks.	Duluth Domestic Violence Program (BIP) n=30 Participants Participants randomized to the Batterer Intervention Program (BIP). BIP: The Batterer Intervention Program (BIP) is a psychoeducational intervention that will be delivered in 50- 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 role plays to teach anger management skills.	Total n=60 Participants Total of all reporting groups
Age, Continuous	35.6 years STANDARD_DEVIATION 7.7 • n=5 Participants	30.6 years STANDARD_DEVIATION 7.4 • n=7 Participants	33.1 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Fathers for Change n=30 Participants Participants randomized to the Fathers for Change (F4C) program. F4C: 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 18 weeks.	Duluth Domestic Violence Program (BIP) n=30 Participants Participants randomized to the Batterer Intervention Program (BIP). BIP: The Batterer Intervention Program (BIP) is a psychoeducational intervention that will be delivered in 50- 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 role plays to teach anger management skills.
Completion Rate	20 Participants	21 Participants

PRIMARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Outcome measures
Measure	Fathers for Change n=25 Participants Participants randomized to the Fathers for Change (F4C) program. F4C: 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 18 weeks.	Duluth Domestic Violence Program (BIP) n=23 Participants Participants randomized to the Batterer Intervention Program (BIP). BIP: The Batterer Intervention Program (BIP) is a psychoeducational intervention that will be delivered in 50- 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 role plays to teach anger management skills.
Working Alliance Inventory Sum Score	62.52 score on a scale Standard Deviation 8.96	55.82 score on a scale Standard Deviation 6.77

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Fathers for Change n=24 Participants Participants randomized to the Fathers for Change (F4C) program. F4C: 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 18 weeks.	Duluth Domestic Violence Program (BIP) n=18 Participants Participants randomized to the Batterer Intervention Program (BIP). BIP: The Batterer Intervention Program (BIP) is a psychoeducational intervention that will be delivered in 50- 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 role plays to teach anger management skills.
Client Satisfaction Sum Score	7.75 score on a scale Standard Deviation .68	7.33 score on a scale Standard Deviation .84

SECONDARY outcome

Timeframe: Baseline and 18 weeks

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.

Outcome measures

Outcome measures
Measure	Fathers for Change n=22 Participants Participants randomized to the Fathers for Change (F4C) program. F4C: 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 18 weeks.	Duluth Domestic Violence Program (BIP) n=20 Participants Participants randomized to the Batterer Intervention Program (BIP). BIP: The Batterer Intervention Program (BIP) is a psychoeducational intervention that will be delivered in 50- 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 role plays to teach anger management skills.
Reflective Functioning Baseline	2.46 score on a scale Standard Error .157	2.57 score on a scale Standard Error .165
Reflective Functioning Posttreatment	2.39 score on a scale Standard Error .121	2.23 score on a scale Standard Error .127

SECONDARY outcome

Timeframe: Baseline and 18 weeks

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.

Outcome measures

Outcome measures
Measure	Fathers for Change n=22 Participants Participants randomized to the Fathers for Change (F4C) program. F4C: 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 18 weeks.	Duluth Domestic Violence Program (BIP) n=21 Participants Participants randomized to the Batterer Intervention Program (BIP). BIP: The Batterer Intervention Program (BIP) is a psychoeducational intervention that will be delivered in 50- 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 role plays to teach anger management skills.
Emotional Regulation Baseline	34.61 score on a scale Standard Error 2.07	28.64 score on a scale Standard Error 2.12
Emotional Regulation Post-Treatment	29.20 score on a scale Standard Error 1.71	28.32 score on a scale Standard Error 1.76

SECONDARY outcome

Timeframe: 18 weeks

Population: imputation for missing data across weeks to increase sample size.

The TimeLine Follow-back-Spousal Violence will be used to characterize the frequency of intimate partner violence.

Outcome measures

Outcome measures
Measure	Fathers for Change n=27 Participants Participants randomized to the Fathers for Change (F4C) program. F4C: 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 18 weeks.	Duluth Domestic Violence Program (BIP) n=25 Participants Participants randomized to the Batterer Intervention Program (BIP). BIP: The Batterer Intervention Program (BIP) is a psychoeducational intervention that will be delivered in 50- 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 role plays to teach anger management skills.
Intimate Partner Violence	1.70 Events/weeks Standard Deviation 4.57	4.28 Events/weeks Standard Deviation 7.41

SECONDARY outcome

Timeframe: 18 weeks

Child maltreatment risk will be assessed using TimeLine Follow-back to assess the frequency of behaviors characterized as child maltreatment.

Outcome measures

Outcome measures
Measure	Fathers for Change n=27 Participants Participants randomized to the Fathers for Change (F4C) program. F4C: 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 18 weeks.	Duluth Domestic Violence Program (BIP) n=25 Participants Participants randomized to the Batterer Intervention Program (BIP). BIP: The Batterer Intervention Program (BIP) is a psychoeducational intervention that will be delivered in 50- 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 role plays to teach anger management skills.
Child Maltreatment	1.19 Events/weeks Standard Deviation 2.47	3.48 Events/weeks Standard Deviation 12.50

Adverse Events

Fathers for Change

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Duluth Domestic Violence Program (BIP)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fathers for Change n=30 participants at risk Participants randomized to the Fathers for Change (F4C) program. F4C: 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 18 weeks.	Duluth Domestic Violence Program (BIP) n=30 participants at risk Participants randomized to the Batterer Intervention Program (BIP). BIP: The Batterer Intervention Program (BIP) is a psychoeducational intervention that will be delivered in 50- 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 role plays to teach anger management skills.
Social circumstances Arrest and Incarceration	10.0% 3/30 • Number of events 4 • 19 weeks In our study we included arrest/incarceration as serious adverse events given the nature of our population with significant criminal histories.	3.3% 1/30 • Number of events 1 • 19 weeks In our study we included arrest/incarceration as serious adverse events given the nature of our population with significant criminal histories.
Injury, poisoning and procedural complications Hospitalization	0.00% 0/30 • 19 weeks In our study we included arrest/incarceration as serious adverse events given the nature of our population with significant criminal histories.	3.3% 1/30 • Number of events 1 • 19 weeks In our study we included arrest/incarceration as serious adverse events given the nature of our population with significant criminal histories.

Other adverse events

Other adverse events
Measure	Fathers for Change n=30 participants at risk Participants randomized to the Fathers for Change (F4C) program. F4C: 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 18 weeks.	Duluth Domestic Violence Program (BIP) n=30 participants at risk Participants randomized to the Batterer Intervention Program (BIP). BIP: The Batterer Intervention Program (BIP) is a psychoeducational intervention that will be delivered in 50- 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 role plays to teach anger management skills.
General disorders ER Visits	3.3% 1/30 • Number of events 2 • 19 weeks In our study we included arrest/incarceration as serious adverse events given the nature of our population with significant criminal histories.	3.3% 1/30 • Number of events 1 • 19 weeks In our study we included arrest/incarceration as serious adverse events given the nature of our population with significant criminal histories.
Injury, poisoning and procedural complications Car Accident	3.3% 1/30 • Number of events 1 • 19 weeks In our study we included arrest/incarceration as serious adverse events given the nature of our population with significant criminal histories.	0.00% 0/30 • 19 weeks In our study we included arrest/incarceration as serious adverse events given the nature of our population with significant criminal histories.
General disorders COVID diagnosis	3.3% 1/30 • Number of events 1 • 19 weeks In our study we included arrest/incarceration as serious adverse events given the nature of our population with significant criminal histories.	0.00% 0/30 • 19 weeks In our study we included arrest/incarceration as serious adverse events given the nature of our population with significant criminal histories.

Additional Information

Carla Stover

Yale University Child Study Center

Phone: 12037853486

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place