Behavioral Health Intervention for Pediatric Injury

Recruiting at 3 trial locations

Overseen By Ebonie Powell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Non-English, Cognitive challenges, Self-afflicted, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

348 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

Leigh Ridings, Ph.D.

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for children under 12 hospitalized with pediatric injury and their caregivers who show signs of acute distress. It's not suitable for those who don't meet the age requirement or distress criteria.

Inclusion Criteria

My child is under 12 and hospitalized due to an injury.

My child shows signs of acute distress according to a specific test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the CAARE intervention, which includes bedside screening, digital health tools, and follow-up for behavioral health management

12 months

Multiple visits as needed for intervention steps

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, and 12 months

12 months

Assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The CAARE program, a technology-assisted behavioral health intervention, is being tested against enhanced usual care to see if it can improve emotional and physical recovery after a child's traumatic injury.

How Is the Trial Designed?

Group I: Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) Experimental Treatment 1 Intervention

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 II: Enhanced usual care (EUC) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+