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

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ClinicalTrials.gov Identifier: NCT04165291
Recruitment Status : Not yet recruiting
First Posted : November 15, 2019
Last Update Posted : November 15, 2019
Sponsor:
Collaborator:
National Institute of Child Health and Human Development/NIH/DHHS
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Intimate Partner Violence Behavioral: F4C Behavioral: BIP Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing a Fatherhood Focused Individual Intervention to Batterer Intervention to Reduce IPV and Child Maltreatment
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2023

Arm Intervention/treatment
Experimental: F4C
Participants randomized to the Fathers for Change (F4C) program.
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.

Active Comparator: BIP
Participants randomized to the Batterer Intervention Program (BIP).
Behavioral: 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.




Primary Outcome Measures :
  1. Completion Rate [ Time Frame: 16 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.

  2. Working Alliance [ Time Frame: 16 weeks ]
    To test the hypothesis that fathers randomized to F4C will report greater working alliance, analysis of variance will be used to test between group differences in working alliance between F4C and BIP.

  3. Client Satisfaction [ Time Frame: 16 weeks ]
    To test the hypothesis that fathers randomized to F4C will report greater client satisfaction, analysis of variance will be used to test between group differences in client satisfaction between F4C and BIP.


Secondary Outcome Measures :
  1. Reflective Functioning [ Time Frame: 16 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.

  2. Emotional Regulation [ Time Frame: 16 weeks ]
    Emotional regulation will be assessed with the Difficulties in Emotion Regulation Scale (DERS). The DERS is a 36-item self-report measure scored on a 5-point Likert-type scale where higher scores indicate greater difficulty in emotional regulation.

  3. Intimate Partner Violence [ Time Frame: 16 weeks ]
    The TimeLine Follow-back-Spousal Violence will be used to characterize the frequency of intimate partner violence.

  4. Child Maltreatment [ Time Frame: 16 weeks ]
    Child maltreatment risk will be assessed using TimeLine Follow-back to assess the frequency of behaviors characterized as child maltreatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04165291


Contacts
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Contact: Carla Stover, PhD (203) 785-3486 carla.stover@yale.edu
Contact: Tami Sullivan, PhD (203) 789-7645 tami.sullivan@yale.edu

Sponsors and Collaborators
Yale University
National Institute of Child Health and Human Development/NIH/DHHS
Investigators
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Principal Investigator: Carla Stover, PhD Associate Professor at the Yale University School of Medicine Child Study Center

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04165291     History of Changes
Other Study ID Numbers: 2000026789
1R21HD099318-01A1 ( Other Grant/Funding Number: National Institute of Child Health and Human Development/NIH/DHHS )
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No