RECRUITING

Improving Behavioral Health for Caregivers and Children After Pediatric Injury

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-05-28
Study Completion:2028-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06856057

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Caregivers (≥18 years old) of children hospitalized with pediatric injury
  2. * Children hospitalized with pediatric injury \<12 years old
  3. * Screen positive on the ASC-Kids (aged 8-11 years) or PDI Caregiver measure of acute distress.
  1. * A caregiver whose primary language is not English
  2. * A cognitive challenge (caregiver or child) that would impair ability to consent
  3. * Presence of a self-afflicted injury
  4. * Presence of injuries resulting from caregiver abuse or neglect (these patients will follow an alternative treatment path).

Contacts and Locations

Study Contact

Leigh Ridings
CONTACT
(843) 792-5146
ridingle@musc.edu
Ebonie Powell
CONTACT
powelebo@musc.edu

Principal Investigator

Leigh Ridings, Ph.D.
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Kentucky Children's Hospital
Lexington, Kentucky, 40536
United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
United States
Children's Memorial Hermann Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Leigh Ridings, Ph.D., PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-28
Study Completion Date2028-08-31

Study Record Updates

Study Start Date2025-05-28
Study Completion Date2028-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Quality of Life
  • PTSD
  • Depression Not Otherwise Specified
  • Child Externalizing Behavior