Helping children and caregivers cope with traumatic injuries
Pediatric and Caregiver Traumatic Stress Intervention: A Path Forward After Injury for Pediatric Survivors and Their Caregivers
This study tests a new program to help children and their caregivers cope with the emotional effects of traumatic injuries, like accidents or burns, to see if it works better than regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 1 Year to 6 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT06366282 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a caregiver-child intervention designed to reduce symptoms of post-traumatic stress disorder and depression in both pediatric trauma patients and their caregivers. The intervention involves dyadic screening and counseling for caregivers of children who have experienced traumatic injuries, such as burns or accidents. Participants will be compared to those receiving standard care to assess improvements in mental health outcomes. The study focuses on identifying and addressing the psychological needs of both the child and caregiver following a traumatic event.
Who should consider this trial
Good fit: Ideal candidates include English-speaking children requiring inpatient treatment for unintentional injuries and their caregivers who screen positive for distress.
Not a fit: Patients and caregivers with cognitive deficits, psychotic symptoms, or those refusing treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health outcomes for children and their caregivers following traumatic injuries.
How similar studies have performed: Other studies have shown promise in using caregiver interventions to improve outcomes in pediatric trauma, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Child requires inpatient treatment for an unintentional injury (e.g. burns, dog bite, road traffic accident) in the pediatric trauma and/or pediatric burns units * English-speaking adults, with English denoted as the primary language in the electronic medical record (EMR) * Caregiver-child dyads who screen positive with the Peritraumatic Distress Inventory (PDI) Tools will be invited to participate in the randomized controlled trial. Exclusion Criteria: * Patients and/or caregivers with cognitive deficits, with psychotic symptoms, refusing treatment, and leaving the hospital against medical advice (AMA) were unable to participate in counseling interventions by condition or by choice and are excluded from the study population
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth Shilling, PhD — Wake Forest University Health Sciences
- Study coordinator: Liz White, MA, LCMHCS
- Email: Elizabeth.B.White@Advocatehealth.org
- Phone: 336-716-2801
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.