Improving Behavioral Health for Caregivers and Children After Pediatric Injury

Recruiting · NCT06856057 · Interventional (participants receive a specific treatment) · Lead sponsor: Medical University of South Carolina

View the official record on ClinicalTrials.gov →

Depression

Interventions studied

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

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).

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

Yes - healthy volunteers may be accepted

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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).

Where it is running

4 locations listed across 4 US states.

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

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →