Improving Behavioral Health for Caregivers and Children After Pediatric Injury
Purpose
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).
Conditions
- Quality of Life
- PTSD
- Depression Not Otherwise Specified
- Child Externalizing Behavior
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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 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).
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
No Intervention Enhanced usual care (EUC) |
Educational packet includes behavioral health education for children and families after pediatric traumatic injury(PTI). |
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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. |
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Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
Lexington, Kentucky 40536
More Details
- NCT ID
- NCT06856057
- Status
- Recruiting
- Sponsor
- Medical University of South Carolina
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, >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.