Clinical trial NCT04165291: Comparing a Fatherhood Focused Individual Intervention to Batterer Intervention to Reduce IPV and Child Maltreatment
Official title: Comparing a Fatherhood Focused Individual Intervention to Batterer Intervention to Reduce IPV and Child Maltreatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intimate Partner Violence
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-11-15
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Completion Rate
timeFrame: 18 weeks
measure: Working Alliance Inventory Sum Score
timeFrame: 8 weeks
measure: Client Satisfaction Sum Score
timeFrame: 18 weeks
Secondary outcomes:
measure: Reflective Functioning
timeFrame: Baseline and 18 weeks
measure: Emotional Regulation
timeFrame: Baseline and 18 weeks
measure: Intimate Partner Violence
timeFrame: 18 weeks
measure: Child Maltreatment
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Hamden
country: United States
facility: Carla Stover
state: Connecticut
Study officials:
affiliation: Associate Professor at the Yale University School of Medicine Child Study Center
name: Carla Stover, PhD
role: PRINCIPAL_INVESTIGATOR
References: