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Recruiting NCT06856057

Improving Behavioral Health for Caregivers and Children After Pediatric Injury

Trial Parameters

Condition Quality of Life
Sponsor Medical University of South Carolina
Study Type INTERVENTIONAL
Phase N/A
Enrollment 348
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-05-28
Completion 2028-08-31
Interventions
Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)

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).

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