Actively Recruiting
Pediatric and Caregiver Traumatic Stress Intervention: A Path Forward After Injury for Pediatric Survivors and Their Caregivers
Led by Wake Forest University Health Sciences · Updated on 2026-04-06
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
C
Childress Institute for Pediatric Trauma
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a caregiver-child screening and intervention approach to reduce traumatic stress and depression symptoms in children who survive traumatic injuries and their caregivers. This study compares a new intervention to the current standard care to better support families at risk of post-traumatic stress disorder or depression following pediatric injury. The trial focuses on pediatric trauma patients and their caregivers to understand how to improve emotional outcomes after injury. Participants are assigned randomly to one of two groups: one group receives screening with the Peritraumatic Distress Inventory (PDI) tool plus caregiver counseling that includes trauma narrative, education, coping skills, and resilience building during a single hospitalization. The other group receives screening with the same PDI tool but continues with the usual standard care provided by the counseling team. Interventions occur during the child's hospital stay. During the study, researchers assess changes in trauma and depression symptoms in both children and caregivers using tools like the Kessler 6, Patient Health Questionnaire-9 (PHQ-9), and Child and Adolescent Trauma Screen (CATS) from baseline through three months. Caregiver-child dyads are monitored to evaluate emotional health improvements, with data collection focusing on symptom changes over time. The total involvement includes initial screening, intervention during hospitalization, and follow-up measurement at three months.
CONDITIONS
Brief Title
Pediatric and Caregiver Traumatic Stress Intervention (PACTS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child requires inpatient treatment for an unintentional injury such as burns, dog bite, or road traffic accident in pediatric trauma or burns units
- Adult caregiver is English-speaking with English as the primary language in medical records
- Caregiver-child pairs who screen positive with the Peritraumatic Distress Inventory (PDI) tool are eligible for randomization
You will not qualify if you...
- Patients or caregivers with cognitive deficits or psychotic symptoms
- Patients or caregivers refusing treatment
- Patients or caregivers leaving the hospital against medical advice (AMA) and unable to participate in counseling interventions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - During single hospitalization
Participants receive caregiver counseling or standard of care focused on trauma and coping strategies during a single hospitalization.
1 to 2 visits during hospitalization
Duration - Up to 3 months after treatment
Participants are assessed for changes in traumatic stress and depressive symptoms up to 3 months after baseline.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
L
Liz White, MA, LCMHCS
D
D'Ann Hershel
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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