NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Improving Behavioral Health for Caregivers and Children After Pediatric Injury
Improving Behavioral Health for Caregivers and Children After Pediatric Injury

NCT06856057

RecruitingNA

Sponsor: Medical University of South Carolina

Conditions: Quality of Life, PTSD, Depression Not Otherwise Specified, Child Externalizing Behavior

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

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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).
Locations (4)
  • Los Angeles, California, United States
  • Lexington, Kentucky, United States
  • Ann Arbor, Michigan, United States
  • Houston, Texas, United States