Communication Intervention for Traumatic Stress Disorders
(EFTI Trial)
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.12345Why 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.12678
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention Development
Co-development and refinement of a clinician coaching communication intervention with feedback from caregivers and clinicians
Intervention Implementation
Clinicians receive the communication intervention, including didactics, audio-recorded clinical encounters, feedback sessions, and post-intervention interviews
Follow-up
Participants are monitored for the impact of the intervention on communication quality, caregiver trust, caregiver satisfaction, and hospital readmissions
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?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Citations
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).
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 ...
Promoting Youth Mental Health Through Equity-Centered ...
The youth mental health crisis is reaching epidemic proportions, stemming from both single and complex traumatic experiences.
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 ...
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. •.
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.pdfKey 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/s12888-025-06473-4Recovery-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 ...
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