Recruiting

Improving Behavioral Health for Caregivers and Children After Pediatric Injury

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…

ClinicalTrials.gov IDNCT06856057
PhaseNA
Enrollment348
SponsorMedical University of South Carolina
Age18 Years
SexALL
I'm interested View official listing

Conditions studied

Quality of Life, PTSD, Depression Not Otherwise Specified, Child Externalizing Behavior

About this study

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).

Interventions

Primary outcomes

Eligibility information

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).

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.