Family-Centered Care for Domestic Violence

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Gunjan Tiyyagura, MD, MHS

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Yale University

Disqualifiers: Ward of state, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Family-Centered Care for Domestic Violence?

Family-centered care (FCC) is widely used in pediatric health care and is considered the standard by many clinical practices, as it involves the whole family in care planning and decision-making. Although its effectiveness hasn't been systematically measured, it is believed to improve health outcomes by fostering a partnership between families and healthcare providers. ^{1 2 3 4 5}

How is the Family-Centered Care treatment for domestic violence different from other treatments?

Family-Centered Care (FCC) is unique because it involves the entire family in the care process, focusing on participation, information sharing, and individualized care for each family member. This approach is different from traditional treatments that may focus solely on the individual, as it considers the impact on and involvement of the whole family. ^{1 3 4 6 7}

Research Team

Gunjan Tiyyagura, MD, MHS

Principal Investigator

Yale University

Eligibility Criteria

This trial is for parents over 18 with a child under 3 who's been exposed to domestic violence and reported to Child Protective Services. Participants must speak English or Spanish, agree to a medical evaluation for the child, and not already be connected to an IPV advocate or be a ward of the state.

Inclusion Criteria

Does not already have a connection to an IPV advocate

I am over 18 and agree to my child's medical evaluation at the advocacy center.

My child under 3 has been reported to CPS due to exposure to IPV.

Exclusion Criteria

Ward of the state

I prefer to communicate in a language other than English or Spanish.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Visit and Assessment

Participants undergo initial assessment and receive either family-focused care or child-focused care

1 day

1 visit (in-person)

Follow-up

Participants are monitored for engagement in IPV-based community services and clinical outcomes for children

up to 1 year

Multiple visits (in-person and virtual)

Evaluation and Outcome Measurement

Evaluation of caregiver engagement, empowerment, and child clinical outcomes

up to 1 year

Treatment Details

Interventions

• CCC (Behavioral Intervention)
• FCC (Behavioral Intervention)

Trial Overview The study compares Family-Centered Care (FCC) with Child-centered care (CCC) in terms of how they affect caregiver engagement in community services, feelings of empowerment, and clinical outcomes for children who have witnessed domestic violence.

Participant Groups

Group I: FCC model Experimental Treatment 1 Intervention

Participants will receive family-focused care.

Group II: CCC model Active Control 1 Intervention

Participants will receive the usual child-focused care.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Nancy J. Brown

Yale University

Chief Medical Officer since 2020

MD from Yale School of Medicine

Peter Salovey

Yale University

Chief Executive Officer since 2013

PhD in Psychology from Yale University

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

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

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

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

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

Findings from Research

The update of the Cochrane review found limited but moderate-quality evidence suggesting that family-centred care (FCC) can improve clinical care and parental satisfaction for hospitalized children, based on one unpublished RCT involving 288 children post-tonsillectomy.

The study indicated that children in a care-by-parent unit received better care and parents were more satisfied compared to standard inpatient care, with lower costs reported, but emphasized the need for larger, high-quality trials to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-centred care for hospitalised children aged 0-12 years. Shields, L., Zhou, H., Pratt, J., et al.[2022]

Family-centered care (FCC) for sick newborns is shifting the focus from provider-centered to client-centered care, aiming to enhance the therapeutic relationship between healthcare providers and families.

The FCC model not only empowers parents with caregiving skills during and after hospital stays but is also being tested at five sites nationwide, with outcomes expected to demonstrate its benefits for newborns, families, and healthcare staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-centered Care for Sick Newborns: A Thumbnail View. Maria, A., Dasgupta, R.[2020]

A study involving 193 parents and patients assessed the importance of family-centered care (FCC) interventions in maternal/child units, highlighting that feeling welcomed at the hospital was the most valued aspect by participants.

The results will guide the implementation of a family-centered care philosophy, addressing the challenges many institutions face in adopting this model of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenging the precepts of family-centered care: testing a philosophy. Galvin, E., Boyers, L., Schwartz, PK., et al.[2014]

A study involving 476 pediatric healthcare providers from the U.S., Australia, and Turkey found that attitudes towards family-centered care (FCC) were generally more positive when working with children compared to their parents, highlighting cultural differences in perceptions of FCC.

The study identified significant differences in FCC perceptions between nurses and physicians, as well as correlations with factors like age, number of children, and education, suggesting that these factors may influence the effectiveness of FCC implementation in different healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How is Family Centered Care Perceived by Healthcare Providers from Different Countries? An International Comparison Study. Feeg, VD., Paraszczuk, AM., Çavuşoğlu, H., et al.[2022]

Both mothers and nurses perceive barriers to family-centered care (FCC) at a moderate level, with no significant difference in their perceptions, based on a study involving 60 nurses and 82 mothers.

Factors such as the age of mothers and the child's admission history significantly influence mothers' perceptions of FCC barriers, indicating a need for targeted strategies to improve collaborative care in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mothers and nurses' perceptions of the family-centered care barriers in pediatric departments of an educational hospital in Iran. Farokhzadian, J., Forouzi, MA., Sheikhbardsiri, H.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Family-centred care for hospitalised children aged 0-12 years. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Family-centered Care for Sick Newborns: A Thumbnail View. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Challenging the precepts of family-centered care: testing a philosophy. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

How is Family Centered Care Perceived by Healthcare Providers from Different Countries? An International Comparison Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Family-centered care: current applications and future directions in pediatric health care. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Mothers and nurses' perceptions of the family-centered care barriers in pediatric departments of an educational hospital in Iran. [2021]

7. Iran pubmed.ncbi.nlm.nih.gov

Family centered care of hospitalized children: A hybrid concept analysis in Iran. [2020]