NCT04165291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
7 months until next milestone

Results Posted

Study results publicly available

April 4, 2024

Completed
Last Updated

April 4, 2024

Status Verified

March 1, 2024

Enrollment Period

2.9 years

First QC Date

November 14, 2019

Results QC Date

January 29, 2024

Last Update Submit

March 7, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (4)

  • Reflective Functioning

    Baseline and 18 weeks

  • Emotional Regulation

    Baseline and 18 weeks

  • Intimate Partner Violence

    18 weeks

  • Child Maltreatment

    18 weeks

Study Arms (2)

F4C

EXPERIMENTAL

Participants randomized to the Fathers for Change (F4C) program.

Behavioral: F4C

BIP

ACTIVE COMPARATOR

Participants randomized to the Batterer Intervention Program (BIP).

Behavioral: BIP

Interventions

F4CBEHAVIORAL

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.

F4C
BIPBEHAVIORAL

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.

BIP

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carla Stover

Hamden, Connecticut, 06514, United States

Location

Results Point of Contact

Title
Carla Stover
Organization
Yale University Child Study Center

Study Officials

  • Carla Stover, PhD

    Associate Professor at the Yale University School of Medicine Child Study Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 15, 2019

Study Start

September 1, 2020

Primary Completion

July 30, 2023

Study Completion

August 30, 2023

Last Updated

April 4, 2024

Results First Posted

April 4, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations