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Communication Intervention for Traumatic Stress Disorders (EFTI Trial)

N/A

Recruiting

Led By Victoria M. Parente, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to develop and test a coaching communication intervention that will improve communication between medical teams and caregivers of children in the hospital, particularly focusing on Black and Latinx caregivers. The intervention will incorporate trauma

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a communication intervention rather than a medical treatment, there may not be physical side effects. However, participants might experience emotional discomfort discussing traumatic experiences as part of the intervention.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM)

Appropriateness measured by the Intervention Appropriateness Measure (IAM)

Caregiver Reported Communication Quality measured by the Interpersonal Processes of Care Short Form

+9 more

Secondary study objectives

Caregiver ability to correctly identify child's diagnosis

Hydrocortisone

Number of Caregiver Participatory Behaviors

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Clinician Coaching Wait-List Control Arm-- CaregiversExperimental Treatment1 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-- CaregiversActive Control1 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.

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