NCT06071299

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Jan 2024Dec 2026

First Submitted

Initial submission to the registry

September 29, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

January 10, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Expected
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

September 29, 2023

Last Update Submit

December 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Percentage of evaluated children who complete a skeletal survey

    up to 4 weeks post visit 1

  • Perceptions of survivor-defined practice using the Survivor Defined Practice Scale (SDPS)

    up to 4 weeks post visit 1

  • Perceptions of safety-related empowerment using the Measure of Victim Empowerment Related to Safety (MOVERS) scale.

    up to 4 weeks post visit 1

  • Frequency of IPV-related episodes assessed using the Psychological Maltreatment of Women Inventory (PMWI)- Short form

    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

    up to 1 year post visit 1, until child is 2 years of age

  • +1 more secondary outcomes

Study Arms (2)

FCC model

EXPERIMENTAL

Participants will receive family-focused care.

Behavioral: FCC

CCC model

ACTIVE COMPARATOR

Participants will receive the usual child-focused care.

Behavioral: CCC

Interventions

FCCBEHAVIORAL

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.

FCC model
CCCBEHAVIORAL

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.

CCC model

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Have a child \< 5-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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

SCAN Clinic

Hartford, Connecticut, 06106, United States

Location

The South Central Child Advocacy Center

New Haven, Connecticut, 06520, United States

Location

Study Officials

  • Gunjan Tiyyagura, MD, MHS

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 6, 2023

Study Start

January 10, 2024

Primary Completion

February 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations