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

Intimate Partner Violence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04165291
• Other study ID #: 2000026789
• Secondary ID: 1R21HD099318-01A
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: August 30, 2023

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intimate Partner Violence

Intervention

Behavioral:
• 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 16 weeks.
• BIP
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.

Locations

Country	Name	City	State
United States	Carla Stover	Hamden	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	18 weeks
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.	8 weeks
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.	18 weeks
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.	Baseline and 18 weeks
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.	Baseline and 18 weeks
Secondary	Intimate Partner Violence	The TimeLine Follow-back-Spousal Violence will be used to characterize the frequency of intimate partner violence.	18 weeks
Secondary	Child Maltreatment	Child maltreatment risk will be assessed using TimeLine Follow-back to assess the frequency of behaviors characterized as child maltreatment.	18 weeks