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

Sponsor
Yale University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06071299
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
335
2
2
48
167.5
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: FCC
  • Behavioral: CCC
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
335 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Impact of Family-Centered Care for Intimate Partner Violence (IPV)
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2027
Anticipated Study Completion Date :
Nov 1, 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Percentage of caregivers with follow-up visits with an IPV advocate [up to 3 months post visit 1]

    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.

Secondary Outcome Measures

  1. Percentage of evaluated children who complete a skeletal survey [up to 4 weeks post visit 1]

    Percentage of evaluated children <1 yr who complete a skeletal survey up to 4 weeks after the initial visit.

  2. Perceptions of survivor-defined practice using the Survivor Defined Practice Scale (SDPS) [up to 4 weeks post visit 1]

    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.

  3. Perceptions of safety-related empowerment using the Measure of Victim Empowerment Related to Safety (MOVERS) scale. [up to 4 weeks post visit 1]

    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.

  4. Immunization status determined by the number of participants that received all recommended vaccinations [up to 1 year post visit 1, until child is 2 years of age]

    Immunization status determined by the number of participants that received all recommended vaccinations at well-child visits by age 2

  5. Number of instances of medical neglect [up to 1 year post visit 1, until child is 2 years of age]

    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?"

  6. 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]

    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.

  7. 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]

    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.

  8. Number of reports to Child Protective Services (CPS) for IPV [up to 1 year post visit 1]

    Number of reports called in to Child Protective Services (CPS) for IPV that identified child as a victim within one year of visit.

  9. Providers acceptability of the FCC model of care [from 3 months post visit 1, up to 1 year]

    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.

  10. Providers feasibility of the FCC model of care [from 3 months post visit 1, up to 1 year]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 3 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 SCAN Clinic Hartford Connecticut United States 06106
2 The South Central Child Advocacy Center New Haven Connecticut United States 06520

Sponsors and Collaborators

  • Yale University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Gunjan Tiyyagura, MD, MHS, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT06071299
Other Study ID Numbers:
  • 2000035185
  • 1K23HD107178-01A1
First Posted:
Oct 6, 2023
Last Update Posted:
Oct 6, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 6, 2023