Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06856057
NA

Improving Behavioral Health for Caregivers and Children After Pediatric Injury

Sponsor: Medical University of South Carolina

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

348

Start Date

2025-05-28

Completion Date

2028-08-31

Last Updated

2025-07-10

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Caregivers' 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).

Locations (4)

Children's Hospital Los Angeles

Los Angeles, California, United States

Kentucky Children's Hospital

Lexington, Kentucky, United States

C.S. Mott Children's Hospital

Ann Arbor, Michigan, United States

Children's Memorial Hermann Hospital

Houston, Texas, United States