Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06856057

Improving Behavioral Health for Caregivers and Children After Pediatric Injury

Led by Medical University of South Carolina · Updated on 2025-07-10

348

Participants Needed

4

Research Sites

170 weeks

Total Duration

On this page

Sponsors

M

Medical University of South Carolina

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Improving Behavioral Health for Caregivers and Children After Pediatric Injury

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Caregivers 18 years or older of children hospitalized with pediatric injury
  • Children hospitalized with pediatric injury younger than 12 years old
  • Positive screen on ASC-Kids (ages 8-11) or PDI Caregiver measure of acute distress
Not Eligible

You will not qualify if you...

  • Caregiver's primary language is not English
  • Cognitive challenges in caregiver or child impairing consent ability
  • Self-inflicted injury present
  • Injury resulting from caregiver abuse or neglect (alternative treatment path followed)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Children's Hospital Los Angeles

Los Angeles, California, United States, 90027

Actively Recruiting

2

Kentucky Children's Hospital

Lexington, Kentucky, United States, 40536

Actively Recruiting

3

C.S. Mott Children's Hospital

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

4

Children's Memorial Hermann Hospital

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

L

Leigh Ridings

CONTACT

E

Ebonie Powell

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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