NCT06856057 Improving Behavioral Health for Caregivers and Children After Pediatric Injury
| NCT ID | NCT06856057 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Quality of Life |
| Study Type | INTERVENTIONAL |
| Enrollment | 348 participants |
| Start Date | 2025-05-28 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 348 participants in total. It began in 2025-05-28 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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 8-11 years) or PDI Caregiver measure of acute distress. Exclusion Criteria: * A caregiver whose primary language is not English * 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).
Contact & Investigator
Leigh Ridings, Ph.D.
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT06856057 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Quality of Life. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06856057 currently recruiting?
Yes, NCT06856057 is actively recruiting participants. Contact the research team at ridingle@musc.edu for enrollment information.
Where is the NCT06856057 trial being conducted?
This trial is being conducted at Los Angeles, United States, Lexington, United States, Ann Arbor, United States, Houston, United States.
Who is sponsoring the NCT06856057 clinical trial?
NCT06856057 is sponsored by Medical University of South Carolina. The principal investigator is Leigh Ridings, Ph.D. at Medical University of South Carolina. The trial plans to enroll 348 participants.