Recruiting

CAARE vs. EUC

Sponsor:

Medical University of South Carolina

Code:

NCT06856057

Conditions

Quality of Life

PTSD

Depression Not Otherwise Specified

Child Externalizing Behavior

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)

Study Details

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 (\<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

Study ID

NCT06856057

Start date

May 28, 2025

Status verified date

Jul, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

348 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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), and provide a referral and warm hand-off to mental health services if needed (Step 4).

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Leigh Ridings

(843) 792-5146ridingle@musc.edu

Ebonie Powell

powelebo@musc.edu

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Ryan Spurrier

323.361.2322rspurrier@chla.usc.edu

Kentucky Children's Hospital

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Meghan Marsac

859-218-9113meghan.marsac@uky.edu

C.S. Mott Children's Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Peter Ehrlich

(734) 763-2072pehrlich@med.umich.edu

Children's Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Linda Ewing-Cobbs

713-500-3873Linda.Ewing-Cobbs@uth.tmc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-07-09.