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

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

Plain Language Summary

Simplified for easier understanding

This study is testing a behavioral health program designed to help caregivers and young children cope with emotional distress after a child has been injured and hospitalized. The goal is to reduce stress and anxiety for both children and their families. **You may be eligible if...** - You are an adult caregiver (18+) of a child under 12 who was hospitalized due to an injury - Your child screened positive for signs of emotional distress following the injury (using a validated screening tool) **You may NOT be eligible if...** - Your primary language is not English - You or your child have a cognitive difficulty that would prevent understanding or consent - The injury was self-inflicted - The injury resulted from caregiver abuse or neglect (these cases follow a separate care pathway) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).


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

View Full Details on ClinicalTrials.gov

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NCT06856057


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