Help for caregivers and children to speed emotional recovery after serious pediatric injury
Official title: Improving Quality of Life and Behavioral Health Service Access for Caregivers and Young Children After Pediatric Traumatic Injury
Run by Medical University of South Carolina · NCT06856057 · Data updated 2026-11-12
This project will test CAARE, a technology-assisted, stepped-care program, to help children under 12 hospitalized for serious injuries and their caregivers recover emotionally compared with enhanced usual care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 348 (estimated) |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 4 sites (Los Angeles, California and 3 other locations) |
| Status | Recruiting |
| Started | May 28, 2025 |
| Main results expected | August 31, 2028 |
| Study ends | August 31, 2028 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT06856057 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Caregivers aged 18 or older with a child under 12 hospitalized for a traumatic injury who screen positive for acute distress are the intended participants.
✕Probably not a fit
Caregivers who do not speak English, have significant cognitive impairment, or whose child's injury was self-inflicted or due to caregiver abuse are excluded and may not benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a hybrid type I effectiveness-implementation randomized trial enrolling 348 families to compare CAARE, a technology-assisted stepped-care behavioral health program, versus guideline-adherent enhanced usual care. Families are randomized 1:1 and receive screening and stepped interventions tailored to caregiver and child distress levels, with care pathways delivered via digital tools plus clinical support. The trial focuses on outcomes including posttraumatic stress, depression, child externalizing behavior, and family quality of life following pediatric traumatic injury. Implementation outcomes and feasibility at multiple U.S. pediatric trauma centers are also measured to support potential wider adoption.
Why it matters
Potential benefit: If successful, CAARE could reduce PTSD and depression symptoms and improve emotional recovery and family quality of life after pediatric injury.
How similar studies have gone: The intervention builds on prior work by the investigative team and aligns with American College of Surgeons guidance, but large randomized tests of technology-assisted stepped-care specifically in pediatric trauma remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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's running
-
Children's Hospital Los Angeles
Los Angeles, California, United States Recruiting -
Kentucky Children's Hospital
Lexington, Kentucky, United States Recruiting -
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States Recruiting -
Children's Memorial Hermann Hospital
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Leigh Ridings, Ph.D. — Medical University of South Carolina
- Study coordinator: Leigh Ridings
- Email: ridingle@musc.edu
- Phone: (843) 792-5146
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.