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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
California
Children's Hospital Los Angeles
RECRUITING
Los Angeles
Kentucky
Kentucky Children's Hospital
RECRUITING
Lexington
Michigan
C.S. Mott Children's Hospital
RECRUITING
Ann Arbor
Texas
Children's Memorial Hermann Hospital
RECRUITING
Houston
Contact Information
Primary
Leigh Ridings
ridingle@musc.edu
(843) 792-5146
Backup
Ebonie Powell
powelebo@musc.edu
Time Frame
Start Date: 2025-05-28
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 348
Treatments
No_intervention: Enhanced usual care (EUC)
Educational packet includes behavioral health education for children and families after pediatric traumatic injury(PTI).
Experimental: Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)
CAARE provides bedside screening and education, digital health tools to help caregivers track and manage emotional and behavioral recovery, and timely follow-up to facilitate screening and referrals (if needed). The 4 steps are: (1) a brief bedside intervention for caregivers and children with positive acute stress risk screens designed to provide coping skills and reduce distress; (2) technology resources including (a) a text message-based tool to facilitate symptom self-monitoring and (b) an mHealth application with embedded learning, coping skills, and service locator tools; (3) a 30-day behavioral health screening, and (4) referral to evidence-based treatment for children and caregivers with positive screens.
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina
Collaborators: National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov