RecruitingNot ApplicableNCT06856057

Improving Behavioral Health for Caregivers and Children After Pediatric Injury

Improving Quality of Life and Behavioral Health Service Access for Caregivers and Young Children After Pediatric Traumatic Injury

Sponsor

Medical University of South Carolina

Enrollment

348 participants

Start Date

May 28, 2025

Study Type

INTERVENTIONAL

Conditions

Quality of Life PTSD Depression Not Otherwise Specified Child Externalizing Behavior

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria4

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).

Interventions

BEHAVIORALCaregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)

CAARE is a technology-enhanced stepped model of care that is designed to deliver education at the bedside to caregivers of children under age 12 years hospitalized for pediatric injury about mental health recovery after pediatric injury as well as risk assessment and brief intervention for high-risk patients (Step 1), foster symptom self-monitoring and reinforcement of coping skills via mHealth tools (Step 2), screen for caregivers' and children's PTSD and depression 30 days post-injury (Step 3), and provide a referral and warm hand-off to mental health services if needed (Step 4).