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

Overview

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).

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.

Interventions

• Behavioral Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)
  CAARE is a technology-enhanced stepped model of care that is designed to deliver education at the bedside to caregivers of children under age 12 years hospitalized for pediatric injury about mental health recovery after pediatric injury as well as risk assessment and brief intervention for high-risk patients (Step 1), foster symptom self-monitoring and reinforcement of coping skills via mHealth tools (Step 2), screen for caregivers' and children's PTSD and depression 30 days post-injury (Step 3)

Primary outcome measures

• Change in scores in child self-report and caregiver proxy-report of child Quality of Life (QOL) [Time frame: From enrollment (baseline) to 3-month, to 6-month, until end of treatment at 12-month]
• Change in scores in caregiver self-report of PTSD [Time frame: From 3-month, to 6-month, until end of treatment at 12-month]
• Change in scores in caregiver self-report of caregiver depression [Time frame: From 3-month, to 6-month, until end of treatment at 12-month]
• Change of child externalizing problems from 3 month to 12 month [Time frame: From 3-month, to 6-month, until end of treatment at 12-month]
• Change in scores in child self-report and caregiver proxy-report of child PTSD [Time frame: From 3-month, to 6-month, until end of treatment at 12-month]
• Change in scores in child self-report (ages 6-11) of child depression [Time frame: From 3-month, to 6-month, until end of treatment at 12-month]

Secondary outcome measures (5)

• Number of caregivers with service engagement [Time frame: From 3-month, to 6-month, until end of treatment at 12-month]
• Mean number of child missed daycare/school days due to pediatric traumatic injury [Time frame: At 3-month, 6-month, and 12-month]
• Change in caregiver health status [Time frame: From enrollment (baseline) to 3-month, to 6-month, to end of treatment at 12-month]
• Change in caregiver work and productivity status [Time frame: From enrollment (baseline) to 3-month, to 6-month, to end of treatment at 12-month]
• Number of children with service engagement [Time frame: From 3-month, to 6-month, until end of treatment at 12-month]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 4 centers

• Children's Hospital Los Angeles — Los Angeles
• Kentucky Children's Hospital — Lexington
• C.S. Mott Children's Hospital — Ann Arbor
• Children's Memorial Hermann Hospital — Houston

Identifiers

NCT: NCT06856057 · Pro00138482 · 1R01HD117024-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗