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Clinician Coaching Wait-List Control Arm-- Caregivers for Post-Traumatic Stress Disorder

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 during hospitalization
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~30-60 minutes before and 20-30 minutes after fcr
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30-60 minutes before and 20-30 minutes after fcr for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Caregiver Post-Traumatic Stress Symptoms as measured by the Impact of Events Scale at 30 days
Caregiver Post-Traumatic Stress Symptoms as measured by the Impact of Events Scale at 90 days
Child Post-Traumatic Stress Symptoms as measured by the Behavioral Assessment System for Children at 30 days
+1 more
Secondary outcome measures
Hydrocortisone
Number of Caregiver Participatory Behaviors
Number of participants with Hospital Readmission at 30 days
+1 more

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.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,364 Previous Clinical Trials
3,420,522 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,677 Total Patients Enrolled
Victoria M. Parente, MDPrincipal InvestigatorDuke University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals actively participating in this research endeavor?

"Indeed, the information found on clinicaltrials.gov indicates that this specific trial is actively seeking participants. Originally shared on February 1st, 2024 and last revised on February 20th, 2024, the study aims to enroll a total of 120 patients at one designated site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pilot Testing of an Equity Focused and Trauma-informed Communication Intervention During Family-centered Rounds
2024. "Pilot Testing of an Equity Focused and Trauma-informed Communication Intervention During Family-centered Rounds". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05618652.
All > Ptsd High Point
~80 spots leftby Jan 2025
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