Improving Behavioral Health for Caregivers and Children After Pediatric Injury

Conditions

• Child Externalizing Behavior
• Depression Not Otherwise Specified
• PTSD
• Quality of Life

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) — BEHAVIORAL
  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), and provide a referral and warm hand-off to mental health services if needed (Step 4).

Study Details

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).

Key Dates

Start date

May 28, 2025

Status verified

Jul 2025

Primary completion

Aug 31, 2028

Completion

Aug 31, 2028

Study Design

Enrollment

348 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Enhanced usual care (EUC)
  Educational packet includes behavioral health education for children and families after pediatric traumatic injury(PTI).
• 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.

Primary Outcome Measure

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 ]

Central Contacts

• Leigh Ridings
  (843) 792-5146
  [email protected]
• Ebonie Powell
  [email protected]

Locations (4)

Find similar trials in Los Angeles, CA

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