Improving Behavioral Health for Caregivers and Children After Pediatric Injury

NCT ID: NCT06856057

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 348 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-28
• Study Completion Date: 2028-08-31

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).

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Enhanced usual care (EUC)

Educational packet includes behavioral health education for children and families after pediatric traumatic injury(PTI).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

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).

Intervention Type: BEHAVIORAL

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 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Leigh Ridings

Assistant Professor-Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leigh Ridings, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

Kentucky Children's Hospital

Lexington, Kentucky, United States

Site Status: RECRUITING

C.S. Mott Children's Hospital

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Children's Memorial Hermann Hospital

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Leigh Ridings

Role: CONTACT

ridingle@musc.edu

(843) 792-5146

Ebonie Powell

Role: CONTACT

powelebo@musc.edu

Facility Contacts

Ryan Spurrier

Role: primary

rspurrier@chla.usc.edu

323.361.2322

Meghan Marsac

Role: primary

meghan.marsac@uky.edu

859-218-9113

Peter Ehrlich

Role: primary

pehrlich@med.umich.edu

(734) 763-2072

Linda Ewing-Cobbs

Role: primary

Linda.Ewing-Cobbs@uth.tmc.edu

713-500-3873

Other Identifiers

1R01HD117024-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00138482

Identifier Type: -

Identifier Source: org_study_id