Improving Behavioral Health for Caregivers and Children After Pediatric Injury
Recruiting now · Not applicable
Conditions studied: Quality of Life, PTSD, Depression Not Otherwise Specified, Child Externalizing Behavior
In brief
Pediatric traumatic injury (PTI) is a public health priority, with more than 125,000 children experiencing injuries that require hospitalization each year. These children, and their caregivers, are affected in many ways that may affect quality of life, emotional and behavioral health, physical recovery, family roles and routines, and academic functioning; yet US trauma centers do not adequately address these outcomes and a scalable national model of care for these families is needed. This proposal builds on prior research from the investigative team to test a technology-assisted, stepped care behavioral health intervention for children (\<12 years) and their caregivers after PTI, CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies), via a hybrid type I effectiveness-implementation trial with 348 families randomly assigned to CAARE (n=174) vs. guideline-adherent enhanced usual care (EUC) (n=174).
Key facts
- Study ID
- NCT06856057
- Run by
- Medical University of South Carolina
- People needed
- 348
- Starts
- 2025-05-28
- Expected to finish
- 2028-08-31
- Last updated by the study team
- 2026-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Caregivers (≥18 years old) of children hospitalized with pediatric injury
- Children hospitalized with pediatric injury \<12 years old
- Screen positive on the ASC-Kids (aged 6-11 years) or PDI Caregiver measure of acute distress.
You may not qualify if…
- A caregiver whose primary language is not English or Spanish
- A cognitive challenge (caregiver or child) that would impair ability to consent
- Presence of a self-afflicted injury
- Presence of injuries resulting from caregiver abuse or neglect (these patients will follow an alternative treatment path).
Where it is running
- Children's Hospital Los Angeles — Los Angeles, California, United States (enrolling)
- Kentucky Children's Hospital — Lexington, Kentucky, United States (enrolling)
- C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States (enrolling)
- Children's Memorial Hermann Hospital — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.