Intimate Partner Violence
Conditions
Brief 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.
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.
Interventions
BEHAVIORALF4C
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.
BEHAVIORALBIP
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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion Rate | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reflective Functioning | 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. |
| Child Maltreatment | 18 weeks | Child maltreatment risk will be assessed using TimeLine Follow-back to assess the frequency of behaviors characterized as child maltreatment. |
| Emotional Regulation | 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. |
| Intimate Partner Violence | 18 weeks | The TimeLine Follow-back-Spousal Violence will be used to characterize the frequency of intimate partner violence. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Fathers for Change | Total | Duluth Domestic Violence Program (BIP) |
|---|---|---|---|
| Age, Continuous | 35.6 years STANDARD_DEVIATION 7.7 | 33.1 years STANDARD_DEVIATION 7.9 | 30.6 years STANDARD_DEVIATION 7.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 32 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 15 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) White | 4 Participants | 7 Participants | 3 Participants |
| Region of Enrollment United States | 30 participants | 60 participants | 30 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 30 Participants | 60 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 3 / 30 | 1 / 30 |
| serious Total, serious adverse events | 3 / 30 | 1 / 30 |
Outcome results
Primary
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.
Time frame: 18 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fathers for Change | Client Satisfaction Sum Score | 7.75 score on a scale | Standard Deviation 0.68 |
| Duluth Domestic Violence Program (BIP) | Client Satisfaction Sum Score | 7.33 score on a scale | Standard Deviation 0.84 |
p-value: 0.08ANOVA
Primary
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.
Time frame: 18 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fathers for Change | Completion Rate | 20 Participants |
| Duluth Domestic Violence Program (BIP) | Completion Rate | 21 Participants |
Primary
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.
Time frame: 8 weeks
Population: Working Alliance was measured at 8 weeks from start of the interventions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fathers for Change | Working Alliance Inventory Sum Score | 62.52 score on a scale | Standard Deviation 8.96 |
| Duluth Domestic Violence Program (BIP) | Working Alliance Inventory Sum Score | 55.82 score on a scale | Standard Deviation 6.77 |
p-value: <0.01ANOVA
Secondary
Child Maltreatment
Child maltreatment risk will be assessed using TimeLine Follow-back to assess the frequency of behaviors characterized as child maltreatment.
Time frame: 18 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fathers for Change | Child Maltreatment | 1.19 Events/weeks | Standard Deviation 2.47 |
| Duluth Domestic Violence Program (BIP) | Child Maltreatment | 3.48 Events/weeks | Standard Deviation 12.5 |
p-value: 0.35ANOVA
Secondary
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.
Time frame: Baseline and 18 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fathers for Change | Emotional Regulation | Baseline | 34.61 score on a scale | Standard Error 2.07 |
| Fathers for Change | Emotional Regulation | Post-Treatment | 29.20 score on a scale | Standard Error 1.71 |
| Duluth Domestic Violence Program (BIP) | Emotional Regulation | Baseline | 28.64 score on a scale | Standard Error 2.12 |
| Duluth Domestic Violence Program (BIP) | Emotional Regulation | Post-Treatment | 28.32 score on a scale | Standard Error 1.76 |
p-value: <0.05Mixed Models Analysis
Secondary
Intimate Partner Violence
The TimeLine Follow-back-Spousal Violence will be used to characterize the frequency of intimate partner violence.
Time frame: 18 weeks
Population: imputation for missing data across weeks to increase sample size.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fathers for Change | Intimate Partner Violence | 1.70 Events/weeks | Standard Deviation 4.57 |
| Duluth Domestic Violence Program (BIP) | Intimate Partner Violence | 4.28 Events/weeks | Standard Deviation 7.41 |
p-value: 0.13ANOVA
Secondary
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.
Time frame: Baseline and 18 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fathers for Change | Reflective Functioning | Baseline | 2.46 score on a scale | Standard Error 0.157 |
| Fathers for Change | Reflective Functioning | Posttreatment | 2.39 score on a scale | Standard Error 0.121 |
| Duluth Domestic Violence Program (BIP) | Reflective Functioning | Baseline | 2.57 score on a scale | Standard Error 0.165 |
| Duluth Domestic Violence Program (BIP) | Reflective Functioning | Posttreatment | 2.23 score on a scale | Standard Error 0.127 |
p-value: 0.116Repeated Measures Analysis of Variance