Clinical trial NCT06856057: Improving Behavioral Health for Caregivers and Children After Pediatric Injury
Official title: Improving Quality of Life and Behavioral Health Service Access for Caregivers and Young Children After Pediatric Traumatic Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Quality of Life
PTSD
Depression Not Otherwise Specified
Child Externalizing Behavior
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2025-03-04
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 (\&lt;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).

Detailed description: Annually, \~8 million children receive emergency care due to injury, over 125,000 of whom experience pediatric traumatic injury (PTI) - injuries so severe that they are hospitalized, typically after motor vehicle crashes, falls, animal attacks, gunshot wounds, or being struck by a car or other object. Roughly 1 in 3 develop posttraumatic stress disorder (PTSD) and/or depression after PTI - risk factors for poor physical recovery, social and school-related impairment, and disruption of roles and routines. Moreover, \&gt;50% of caregivers of children with PTI are highly distressed in the acute stages of recovery and themselves have high risk of PTSD and depression. This is concerning because caregivers' mental health is highly correlated with children's outcomes. Interventions that improve families' quality of life and emotional and behavioral recovery after PTI are a public health priority. However, trauma centers do not currently have best-practice interventions in place to address this need. Studies led by our team found that few Level 1 pediatric trauma centers have embedded behavioral health programs and that there is high interest in learning how to implement such programs. Many centers are eager to implement cost-efficient models of care. The 2022 American College of Surgeons guidelines explicitly recommend mental health intervention. Pediatric trauma centers therefore are ideally positioned and motivated to embed best-practice care to address the emotional and behavioral needs of children and families.

Eligibility criteria: Inclusion Criteria:

* Caregivers (≥18 years old) of children hospitalized with pediatric injury
* Children hospitalized with pediatric injury \&lt;12 years old
* Screen positive on the ASC-Kids (aged 8-11 years) or PDI Caregiver measure of acute distress.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Change in scores in child self-report and caregiver proxy-report of child Quality of Life (QOL)
timeFrame: From enrollment (baseline) to 3-month, to 6-month, until end of treatment at 12-month
measure: Change in scores in caregiver self-report of PTSD
timeFrame: From 3-month, to 6-month, until end of treatment at 12-month
measure: Change in scores in caregiver self-report of caregiver depression
timeFrame: From 3-month, to 6-month, until end of treatment at 12-month
measure: Change of child externalizing problems from 3 month to 12 month
timeFrame: From 3-month, to 6-month, until end of treatment at 12-month
measure: Change in scores in child self-report and caregiver proxy-report of child PTSD
timeFrame: From 3-month, to 6-month, until end of treatment at 12-month
measure: Change in scores in child self-report (ages 6-11) of child depression
timeFrame: From 3-month, to 6-month, until end of treatment at 12-month
Secondary outcomes:
measure: Number of caregivers with service engagement
timeFrame: From 3-month, to 6-month, until end of treatment at 12-month
measure: Mean number of child missed daycare/school days due to pediatric traumatic injury
timeFrame: At 3-month, 6-month, and 12-month
measure: Change in caregiver health status
timeFrame: From enrollment (baseline) to 3-month, to 6-month, to end of treatment at 12-month
measure: Change in caregiver work and productivity status
timeFrame: From enrollment (baseline) to 3-month, to 6-month, to end of treatment at 12-month
measure: Number of children with service engagement
timeFrame: From 3-month, to 6-month, until end of treatment at 12-month
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Leigh Ridings, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: