Actively Recruiting

Phase Not Applicable
Age: 1Year - 6Years
All Genders
ID06366282

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

Age: 1Year - 6Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Outpatient Treatment

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

Follow-up

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

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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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