Clinical trial NCT06071299: Impact of Family-Centered Care for Intimate Partner Violence (IPV)
Official title: Impact of Family-Centered Care for Intimate Partner Violence (IPV)
Study type: INTERVENTIONAL
Overall status: RECRUITING
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: 2023-10-06
Enrollment: 335
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An anticipated 100 caregivers and 100-150 children of these caregivers, and 85 professionals. Participants will be randomized (1:1) child-caregiver dyads who are reported to the New Haven, Milford and Hartford child protective services (CPS) offices after identified exposure to IPV to either the FCC model or usual child-focused care.
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of caregivers with follow-up visits with an IPV advocate
timeFrame: up to 3 months post visit 1
Secondary outcomes:
measure: Percentage of evaluated children who complete a skeletal survey
timeFrame: up to 4 weeks post visit 1
measure: Perceptions of survivor-defined practice using the Survivor Defined Practice Scale (SDPS)
timeFrame: up to 4 weeks post visit 1
measure: Perceptions of safety-related empowerment using the Measure of Victim Empowerment Related to Safety (MOVERS) scale.
timeFrame: up to 4 weeks post visit 1
measure: Immunization status determined by the number of participants that received all recommended vaccinations
timeFrame: up to 1 year post visit 1, until child is 2 years of age
measure: Number of instances of medical neglect
timeFrame: up to 1 year post visit 1, until child is 2 years of age
measure: Frequency of IPV-related episodes assessed using the Psychological Maltreatment of Women Inventory (PMWI)- Short form
timeFrame: up to 1 year post visit 1, until child is 2 years of age
measure: Frequency of IPV-related episodes assessed using the Conflict Tactic Scale 2 (CTS2) for partner's behaviors
timeFrame: up to 1 year post visit 1, until child is 2 years of age
measure: Number of reports to Child Protective Services (CPS) for IPV
timeFrame: up to 1 year post visit 1
measure: Providers acceptability of the FCC model of care
timeFrame: from 3 months post visit 1, up to 1 year
measure: Providers feasibility of the FCC model of care
timeFrame: from 3 months post visit 1, up to 1 year
Other outcomes:
Locations:
city: Hartford
country: United States
facility: SCAN Clinic
state: Connecticut
city: New Haven
country: United States
facility: The South Central Child Advocacy Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Gunjan Tiyyagura, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: