Educational Program for Domestic Violence Survivors

Overseen By Maureen Sanderson, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Meharry Medical College

Disqualifiers: Not Black female, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate a new program designed to support Black women in middle Tennessee who have experienced intimate partner violence. It will test a special care approach called Trauma and Violence Informed Care Intervention, comparing it with the usual care provided. Women who are patients at Meharry or Matthew Walker Comprehensive Health Center, identify as Black, and have survived intimate partner violence may be eligible to join. Participants need to speak English or Spanish to take part in the study.

As an unphased trial, this study offers participants the chance to contribute to innovative care solutions that could significantly enhance support for survivors of intimate partner violence.

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 prior data suggests that this educational program is safe for participants?

Research has shown that trauma and violence-informed care programs are generally safe and well-received. These programs help individuals heal from past trauma, such as domestic violence, by fostering a supportive environment that acknowledges the impact of trauma on well-being.

The Substance Abuse and Mental Health Services Administration (SAMHSA) has established guidelines for trauma-informed care, demonstrating that these approaches can be beneficial without causing harm. No major reports of negative effects from these programs have emerged. Instead, they are designed to be sensitive to survivors' needs, ensuring participants feel safe and supported throughout.

Overall, trauma and violence-informed care is considered safe for participants, as it prioritizes their emotional and psychological safety while aiding recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Trauma and Violence Informed Care (TVIC) Intervention because it offers a more holistic approach to supporting domestic violence survivors. Unlike traditional care, which often focuses solely on physical safety and immediate needs, TVIC emphasizes understanding the deep, lasting impact of trauma and violence on survivors. This method aims to integrate emotional and psychological support with practical assistance, potentially leading to more comprehensive healing and empowerment. By addressing the root causes and effects of trauma, TVIC has the potential to significantly improve the well-being and resilience of survivors compared to usual care approaches.

What evidence suggests that this trauma and violence informed care intervention is effective for domestic violence survivors?

Research has shown that Trauma and Violence Informed Care (TVIC), which participants in this trial may receive, can help people who have experienced violence. This approach works by understanding how trauma and social factors affect a person's health. For survivors of domestic violence, TVIC can improve mental health and overall well-being. It has been successfully used in regular health care settings, reducing trauma symptoms effectively. Similar therapies focused on trauma have proven effective for various types of interpersonal violence, including domestic violence. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for Black women who are patients at Meharry or Matthew Walker Comprehensive Health Center, can communicate fluently in English or Spanish, and identify themselves as survivors of intimate partner violence. It's not open to those who don't meet these specific criteria.

Inclusion Criteria

Meharry or Matthew Walker Comprehensive Health Center female patients

Self-identify as Black

Self-identify as intimate partner violence survivors

Exclusion Criteria

Not Black female intimate partner violence survivor of Meharry or Matthew Walker Comprehensive Health Center

Those without English or Spanish language fluency

Timeline for a Trial Participant

Stakeholder Engagement

Engage a stakeholder committee of patients, providers, and experts to adapt a TVIC intervention for Black women and their healthcare providers

2 years

Provider-Level Implementation

Implement and evaluate the adapted TVIC intervention at the healthcare provider-level, measuring changes in self-efficacy and alignment with TIC knowledge, attitudes, and practices

1 year

Patient-Level Implementation

Implement the adapted TVIC intervention at the patient-level to provide trauma-informed IPV screening, brief interventions, and referrals to treatment, and evaluate its impact

2 years

Follow-up

Participants are monitored for the effectiveness of the intervention and its impact on patient-perceived usefulness and clinic-level changes

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Trauma and Violence Informed Care Intervention

Trial Overview

The study is testing educational materials tailored for Black women who have experienced domestic violence. The goal is to adapt and assess how trauma and violence informed care interventions work within this community in middle Tennessee.

How Is the Trial Designed?

Group I: TVIC Intervention Experimental Treatment 1 Intervention

Group II: Usual Care Active Control 1 Intervention

Trauma and Violence Informed Care Intervention is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Trauma-Informed Care for:

• Domestic violence services
• Intimate partner violence support
• Trauma recovery

Approved in Canada as Trauma- and Violence-Informed Care for:

• Victim services
• Trauma support
• Violence prevention

Approved in European Union as Trauma-Informed Practice for:

• Mental health services
• Social work
• Healthcare settings

Who Is Running the Clinical Trial?

Meharry Medical College

Lead Sponsor

Trials

19

Recruited

6,000+

Matthew Walker Comprehensive Health Center

Collaborator

Trials

3

Recruited

1,300+

Published Research Related to This Trial

The integration of a violence intervention program (VIP) into two Level 1 Pediatric Trauma Centers significantly increased provider-driven referrals from 34.8% to 86.8% over four years, indicating improved identification of patients needing support.

Participants in the educational workshops reported a 21% increase in comfort levels with trauma-informed care (TIC), with medical students showing the greatest improvement, suggesting that the curriculum effectively enhanced understanding and application of TIC principles among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training Hospital Personnel in Trauma-Informed Care: Assessing an Interprofessional Workshop With Patients as Teachers. McNamara, M., Cane, R., Hoffman, Y., et al.[2021]

Trauma-informed care (TIC) is recognized as the clinical standard for treating patients who have experienced sexual trauma, emphasizing the importance of understanding the impact of trauma on individuals.

TIC is built on five core principles: safety, choice, collaboration, trustworthiness, and empowerment, which guide healthcare providers in delivering sensitive and effective care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Can a Trauma-Informed Care Approach Be Applied to Patients With Gynecologic Cancer? Wilson, CM., Parrish, H.[2023]

A simulation-based training program for 17 medical students significantly improved their confidence in applying trauma-informed care (TIC) principles in acute care settings, with statistically significant results (p ≤ .01).

Students reported feeling more familiar with TIC-specific skills, such as trauma screenings and history taking, indicating that simulation is an effective educational tool for preparing future healthcare providers to address trauma-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-Informed Care for Acute Care Settings: A Novel Simulation Training for Medical Students. Lee, CH., Santos, CD., Brown, T., et al.[2023]

Trauma- and violence-informed care (TVIC) education significantly improved health and social service providers' understanding of the connections between trauma, pain, and substance use, leading to more empathetic and effective care practices.

Participants reported that TVIC training fostered better interactions with service users, resulting in increased trust and satisfaction, although the changes in actual behaviors were less pronounced than changes in attitudes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impacts of trauma- and violence-informed care education: A mixed method follow-up evaluation with health & social service professionals. Wathen, CN., MacGregor, JCD., Beyrem, S.[2022]

A study involving 15 faculty interviews and surveys from 99 nursing students highlighted a strong consensus on the importance of trauma-informed care (TIC) education in nursing programs.

Despite recognizing the significance of TIC, nursing students expressed feeling unprepared to implement TIC practices in their future roles, indicating a gap in current nursing education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Faculty, Preceptor, and Students' Perceptions of the Need for Trauma-Informed Education: Recommendations for Implementation. Kuzma, EK., Cannon, LM., Coolidge, EM., et al.[2023]

A study involving 95 APRN students used Q methodology to identify four distinct viewpoints on trauma-informed care (TIC), highlighting the diversity in student perceptions and comfort levels regarding TIC in their learning experiences.

All students recognized the importance of learning about TIC for effective practice, indicating a universal acknowledgment of its relevance, but also revealing varying degrees of anxiety and confidence that educators need to address to support their learning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-informed care: Insights from a Q-methodology study of advanced practice registered nursing students. Tornwall, J., Holod, AF., Teall, AM., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9527731/

Trauma- and Violence-Informed Care: Orienting Intimate ...

Work from the US Substance Abuse and Mental Health Administration [34] specific to women, violence, and substance use helped establish the ...

2.

gtvincubator.uwo.ca

gtvincubator.uwo.ca/wp-content/uploads/2020/05/TVIC_Backgrounder_Fall2019r.pdf

Trauma- & Violence-Informed Care:

This integrated approach explicitly positions experiences of violence and trauma as highly linked to social/structural determinants of health – a fact supported ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10940237/

Effectiveness of Trauma-Informed Care Implementation in ...

Trauma Violence Abuse. 2021;22(5):1057–1067. 10.1177 ... Integrating trauma and violence informed care in primary health care settings ...

4.

link.springer.com

link.springer.com/article/10.1007/s10896-025-00989-9

Separate and Cumulative Impacts of Trauma-Informed ...

IPV, which can include physical violence, emotional abuse, sexual assault, stalking, control, use of one's children as a form of abuse, and/or ...

5.

tandfonline.com

tandfonline.com/doi/full/10.1080/10503307.2024.2353890

Trauma-focused treatments for victims of interpersonal ...

This study demonstrates that trauma-focused therapies are effective across different types of interpersonal violence, including sexual assault, domestic ...

6.

canada.ca

canada.ca/en/public-health/services/publications/health-risks-safety/trauma-violence-informed-approaches-policy-practice.html

Trauma and violence-informed approaches to policy ...

For example, child abuse, including neglect and exposure to intimate partner violence, can impact children's emotional and social development— ...

7.

nnedv.org

nnedv.org/spotlight_on/understanding-importance-trauma-informed-care/

Understanding the Importance of Trauma-Informed Care

It is no secret that survivors of domestic violence need time to feel safe again even after the danger of abuse is gone. However, meeting the needs of ...

8.

frontiersin.org

frontiersin.org/journals/global-womens-health/articles/10.3389/fgwh.2024.1404599/full

s-CAPE trauma recovery program: the need for a holistic ...

Domestic violence perpetrators tend to engage in a combination of these types of violent behaviour (5). The World Health Organization (WHO) ...