Communication Intervention for Traumatic Stress Disorders

(EFTI Trial)

Overseen By Victoria M. Parente, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Child abuse/neglect evaluation, others

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

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new communication method to improve interactions between medical teams and caregivers of hospitalized children. It focuses on building better partnerships and trust with Black and Latinx caregivers by using trauma-informed care (care that understands and responds to trauma) and racial equity principles. Researchers aim to determine if this approach, called the Equity Focused and Trauma-Informed Communication Intervention, improves communication quality, caregiver satisfaction, and reduces hospital readmissions. Caregivers who are primary guardians of hospitalized Black or Latino children on the general pediatrics team are well-suited to participate. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance caregiver communication and satisfaction.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on improving communication between medical teams and caregivers.

What prior data suggests that this communication intervention is safe for caregivers and clinicians?

Research has shown that trauma-informed care, a component of the communication method being tested, is generally well-received. A review of studies found that trauma-informed practices in healthcare can improve outcomes without causing harm. This method focuses on understanding and addressing the effects of trauma, aiming to make patients feel safe and respected.

Additionally, strategies emphasizing fairness, also part of the method, have been used in schools to boost mental health and improve environments. These strategies focus on equal treatment, which can help build trust and satisfaction.

Overall, research suggests that these methods are safe for use in healthcare. They aim to enhance communication and support without introducing significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel communication intervention aimed at improving interactions between clinicians and caregivers of hospitalized children dealing with traumatic stress disorders. Unlike traditional treatments that might focus on medication or therapy for the child, this method emphasizes enhancing the communication skills of clinicians through coaching and feedback. This could lead to a more supportive and understanding hospital environment, potentially increasing the well-being of both the child and their caregivers. By focusing on equity and trauma-informed care, the intervention aims to ensure all families receive compassionate and effective support tailored to their unique experiences.

What evidence suggests that this communication intervention is effective for improving communication with caregivers of hospitalized children?

Research shows that trauma-informed care can enhance communication and build trust between medical teams and caregivers. This trial will evaluate an Equity Focused and Trauma-Informed Communication Intervention. A review of studies has found that trauma-informed approaches can reduce symptoms of PTSD (post-traumatic stress disorder), depression, and anxiety in patients. Trauma-informed care focuses on understanding and addressing the effects of trauma, leading to better interactions and care. By incorporating elements of racial fairness, this approach aims to address health disparities affecting children of color. Researchers believe it improves caregiver satisfaction and may reduce the likelihood of patients returning to the hospital. ^{1 2 6 7 8}

Who Is on the Research Team?

Victoria M. Parente, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking adults who are the primary caregivers of hospitalized Black or Latino children at Duke Children's Hospital. It excludes those involved in child abuse/neglect cases or when family-centered rounds aren't suitable.

Inclusion Criteria

I can understand and agree to the study's details.

I am a pediatrician providing care at Duke Children's Hospital.

I do not provide care to children in a hospital setting on the general pediatrics team.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Co-development and refinement of a clinician coaching communication intervention with feedback from caregivers and clinicians

Not specified

Intervention Implementation

Clinicians receive the communication intervention, including didactics, audio-recorded clinical encounters, feedback sessions, and post-intervention interviews

Up to 12 months

8 audio-recorded clinical encounters, 4 feedback sessions

Follow-up

Participants are monitored for the impact of the intervention on communication quality, caregiver trust, caregiver satisfaction, and hospital readmissions

Up to 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Equity Focused and Trauma-Informed Communication Intervention

Trial Overview The study tests a communication intervention aimed to enhance interactions between medical teams and caregivers during hospital rounds, focusing on partnership, respect, and collaboration with an emphasis on trauma-informed care and racial equity.

How Is the Trial Designed?

Group I: Clinician Coaching Wait-List Control Arm-- Caregivers Experimental Treatment 1 Intervention

Clinicians in the wait-list control arm will initially serve as the control arm then receive the intervention to provide feasibility and acceptability data. The clinicians randomized the control arm will undergo didactics and feedback once their pre-intervention audio-recordings are complete. Caregivers of hospitalized children will not know if their clinician has yet received the communication intervention. The investigators will recruit 40 caregivers in this arm prior to clinicians receiving the intervention.

Group II: Clinician Coaching Immediate Intervention Arm-- Caregivers Active Control 1 Intervention

Clinicians who receive the intervention will participate for up to 12 months, which includes completion of didactics, 8 audio-recorded clinical encounters, 4 feedback sessions, and completion of a post-intervention brief interview and survey. After completing didactic training elements, clinicians will receive coaching and professional feedback on their communication with caregivers of children in the hospital. The investigators will provide clinicians with illustrative examples from their encounters to prompt discussion and self-reflection. Caregivers of hospitalized children will not know if their clinician has received the communication intervention. The investigators will recruit 40 caregivers in this arm.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8219147/

Trauma informed interventions: A systematic review - PMC Fifteen studies found improvements in three main psychological outcomes including PTSD symptoms (11 of 23), depression (9 of 16), and anxiety (5 of 10).

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

Effectiveness of Trauma-Informed Care Implementation in ... This study aimed to understand the mechanisms and outcomes effective in implementing TIC across health systems using a systematic review of reviews and realist ...

3. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ps.20250126

Promoting Youth Mental Health Through Equity-Centered ... The youth mental health crisis is reaching epidemic proportions, stemming from both single and complex traumatic experiences.

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0252747

Trauma informed interventions: A systematic review | PLOS One Fifteen studies found improvements in three main psychological outcomes including PTSD symptoms (11 of 23), depression (9 of 16), and anxiety (5 ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/23727322211031583

Equity-Focused, Trauma-Informed Policy Can Mitigate ... COVID-19 exacerbates health disparities, including traumatic stress, that children of color already experience due to structural racism. •.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12198790/

Innovative approaches to equity research in trauma The Summit on the Advancement of Focused Equity Research in Trauma (SAFER-Trauma) convened to discuss strategies to support research to eliminate disparities ...

7. samhsa.gov samhsa.gov/sites/default/files/programs_campaigns/childrens_mental_health/atc-whitepaper-040616.pdf

Key Ingredients for Successful Trauma-Informed Care ... Health care providers and policymakers need more guidance on how to collect data and track outcomes specific to trauma-informed care. ... “Defining Trauma and ...

8. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-025-06473-4

Recovery-oriented and trauma-informed care for people with ... New approaches, such as recovery-oriented care (ROC) and trauma-informed care (TIC) emphasize the users' needs and experiences and promote autonomy and human ...