Improving Behavioral Health for Caregivers and Children After Pediatric Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
A caregiver whose primary language is not English
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).
Trial design
Treatments tested in this trial
- Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)
Treatment groups
348 Participants
are divided into 2 treatment groupsSponsors and collaborators
Medical University of South Carolina
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov