Impact of Family-Centered Care for Intimate Partner Violence (IPV)

The purpose of the study will be to determine how participation in Family-Centered Care (FCC) compared to Child-centered care (CCC) will affect caregiver engagement in IPV-based community services, caregiver perceptions of empowerment and survivor-defined practice, and clinical outcomes for children exposed to IPV.

Study Overview

• Status: Recruiting
• Conditions: Intimate Partner Violence
• Intervention / Treatment: Behavioral: FCC; Behavioral: CCC

Detailed Description

The study population includes victims of intimate partner violence whose children < 3-years old have been referred to Child Protective Services due to exposure to IPV and who have agreed to a medical evaluation for the child(ren) in the child advocacy center or the SCAN clinic and don't already have a connection to an IPV advocate. The study population will include adults who are primarily English or Spanish Language preferring. For professionals, the target audience will be local CPS investigators in the New Haven and Hartford CPS office, IPV advocates at the New Haven Umbrella Center for Intimate Partner Violence Services and The Hartford Interval House and child abuse pediatricians at Yale University School of Medicine and at the Connecticut Childrens Medical Center.

• Study Type: Interventional
• Enrollment (Estimated): 335
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gunjan Tiyyagura, MD, MHS; Phone Number: 203-464-6343; Email: gunjan.kamdar@yale.edu

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Not yet recruiting
      • SCAN Clinic
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • The South Central Child Advocacy Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have a child < 3-years-old who been reported to Child Protectives Services for IPV exposure
• Parent > 18 years old who has agreed to a medical evaluation for the child at the child advocacy center
• Does not already have a connection to an IPV advocate
• Able to speak English or Spanish fluently
• Not a ward of department of children and families

Exclusion Criteria:

• Ward of the state
• Language preference other than English or Spanish

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FCC model; Participants will receive family-focused care.	Behavioral: FCC; Children evaluated for abusive injuries. Caregiver offered meeting with IPV advocate during visit (survivor-centered care, immediate access to services; continued engagement with advocate for ongoing needs). Referral to Child-Study center for trauma follow up. Connection to pediatrician. Use of motivational interviewing to address IPV.
Active Comparator: CCC model; Participants will receive the usual child-focused care.	Behavioral: CCC; Children evaluated for abusive injuries. Medical provider offers IPV resources to caregiver. Referral to Child-Study center for trauma follow up. Connection to pediatrician. Use of motivational interviewing to address IPV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of caregivers with follow-up visits with an IPV advocate	Percentage of caregivers who have at least one follow-up visit with an IPV advocate by 3 months after the initial visit by self-report.	up to 3 months post visit 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of evaluated children who complete a skeletal survey	Percentage of evaluated children <1 yr who complete a skeletal survey up to 4 weeks after the initial visit.	up to 4 weeks post visit 1
Perceptions of survivor-defined practice using the Survivor Defined Practice Scale (SDPS)	The SDPS is a nine-item measure that assesses intimate partner violence survivors' perception of the degree to which their advocates help them achieve goals they set for themselves, facilitate a spirit of partnership, and show sensitivity to their individual needs and styles. Items are scored on a scale of 1-4 (strongly disagree to strongly agree). Total score range of 9-36. Higher scores indicate a better perception of advocates help.	up to 4 weeks post visit 1
Perceptions of safety-related empowerment using the Measure of Victim Empowerment Related to Safety (MOVERS) scale.	MOVERS is a 13-item scale that measures survivor empowerment within the domain of safety. MOVERS is composed of three subscales that assess distinct domains of safety related empowerment: Internal Tools, Expectation of Support, and Trade-offs. Participants respond to each item using a five-point Likert scale (from "never true" to "always true") with the Trade-offs subscale being reversed scored. Scores on each subscale are summed to produce total scores. Higher scores indicate an increase in safety related empowerment.	up to 4 weeks post visit 1
Immunization status determined by the number of participants that received all recommended vaccinations	Immunization status determined by the number of participants that received all recommended vaccinations at well-child visits by age 2	up to 1 year post visit 1, until child is 2 years of age
Number of instances of medical neglect	Number of instances of medical neglect will be assessed using a single question: "Please tell me how many times in the last year this has happened to you in trying to care for your child. How many times were you not able to make sure infant got to the doctor or hospital when he/she needed it?"	up to 1 year post visit 1, until child is 2 years of age
Frequency of IPV-related episodes assessed using the Psychological Maltreatment of Women Inventory (PMWI)- Short form	The PMWI is a 14 item questionnaire that assesses psychological maltreatment. Response options on a 5-point Likert scale, ranging from never (1) to very often (5), for the last 6 months. Total score range from 14-70 with higher scores indicating more psychologically abusive experiences.	up to 1 year post visit 1, until child is 2 years of age
Frequency of IPV-related episodes assessed using the Conflict Tactic Scale 2 (CTS2) for partner's behaviors	The physical assault portion of the CTS2 is a 12 item questionnaire assessing chronicity and prevalence of IPV. Each item is scored on an 7-point Likert scale, ranging from 0 (never) to 6 (>20 times). Only items referring to the partner's behaviors will be included. Total scores range from 0-300 (for chronicity) and 0-12 (for prevalence) with higher scores denoting increased frequency of intimate partner violence.	up to 1 year post visit 1, until child is 2 years of age
Number of reports to Child Protective Services (CPS) for IPV	Number of reports called in to Child Protective Services (CPS) for IPV that identified child as a victim within one year of visit.	up to 1 year post visit 1
Providers acceptability of the FCC model of care	Acceptability of the FCC model of care by providers will be assessed using the 4- question Acceptability of Intervention Measure (AIM) to assess approval and general liking of the Family-centered care model. Each question is scored on a 5-point Likert scale with a total score range of 4-20. Higher scores indicate more acceptability.	from 3 months post visit 1, up to 1 year
Providers feasibility of the FCC model of care	Feasibility of the FCC model of care by providers will be assessed using the 4-question Feasibility of Intervention Measure (FIM) to assess perceptions of practicability and ease of use of family-centered care. Each question is scored on a 5-point Likert scale with a total score range of 4-20. Higher scores indicate more acceptability.	from 3 months post visit 1, up to 1 year

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Gunjan Tiyyagura, MD, MHS, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: September 29, 2023
• First Submitted That Met QC Criteria: September 29, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2000035185; 1K23HD107178-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No