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?

This trial explores a new approach to help children under 12 and their caregivers recover emotionally and behaviorally after serious injuries requiring hospitalization. Researchers aim to determine if a support system called CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies) can better assist families than standard care, with a focus on emotional health and family routines. Families will receive either the CAARE intervention, which includes tools and follow-up support, or enhanced usual care with educational materials. The trial seeks caregivers of children hospitalized due to injury who show signs of acute stress. As an unphased trial, this study offers families the chance to contribute to pioneering research that could improve recovery support for children and caregivers.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this behavioral health intervention is safe for children and their caregivers?

Research has shown that the Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) program is generally safe for both children and their caregivers. This program aids families in managing emotional and behavioral recovery after a child sustains an injury. It provides support at the hospital, digital tools, and follow-up care.

Studies suggest that caregivers play a crucial role in a child's recovery by reducing distress and managing trauma-related symptoms. Although specific negative events are not mentioned in the sources, the emphasis on support and education indicates a low risk of problems. This approach empowers caregivers to assist in their child's recovery, offering a safe and supportive environment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) protocol because it offers a comprehensive approach to addressing emotional and behavioral recovery after pediatric injuries, which is not typically emphasized in standard care. Unlike traditional treatments that might focus solely on physical recovery, CAARE includes bedside interventions to provide coping skills, integrates digital health tools for ongoing support, and ensures timely follow-up and referrals to evidence-based treatments. This holistic focus not only aids in quicker emotional recovery but also empowers caregivers with resources and skills to support their children effectively.

What evidence suggests that the CAARE intervention is effective for pediatric traumatic injury?

Research has shown that after a serious injury, about one in three children may develop PTSD or depression. More than half of their caregivers also experience high stress and PTSD symptoms. In this trial, participants may receive the CAARE program, designed to help both children and caregivers recover by providing support at the hospital, digital tools, and follow-up care. Early results from similar programs suggest these methods can reduce stress and mental health issues. The CAARE program includes training in coping skills and offers tech resources, such as a mobile app, to help track and manage recovery. Studies have demonstrated that these tools effectively support emotional health. ^{1 2 4 6 7}

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+

Citations

1. nursing.musc.edu nursing.musc.edu/research/funded-projects/behavioral-health-service-access

Improving Quality of Life and Behavioral Health Service ... One in three children endorse PTSD and/or depression symptoms after PTI, and over 50% of caregivers develop high distress and significant PTSD ...

2. nursing.musc.edu nursing.musc.edu/research/funded-projects/pediatric-traumatic-injury

A Scalable mHealth Resource to Facilitate Behavioral and ... The candidate proposes to develop and systematically evaluate CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies), an intervention ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9329229/

Caregivers' and Young Children's Emotional Health Needs ... In the United States, roughly 9.2 million children receive emergency care due to pediatric injury annually, with nearly 300,000 experiencing pediatric traumatic ...

4. muschealth.org muschealth.org/health-professionals/progressnotes/2022/fall/mental-health-following-severe-injury

Program at MUSC addresses mental health following ... Trauma Resilience and Recovery Program helps curb PTSD and depression after traumatic injury.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11546349/

Family Health Care Needs in a Pediatric Population 6 Months ... Caregivers play a crucial role in supporting children following pediatric physical injury, and younger children receive more caregiver ...

6. withpower.com withpower.com/clinical-trials/for-post-traumatic-stress-disorder?page=4

Top Post-Traumatic Stress Disorder Clinical Trials | Power Pediatric traumatic injury (PTI) is a public health priority, with more than 125,000 children experiencing injuries that require hospitalization each year.

7. publications.aap.org publications.aap.org/pediatrics/article/136/4/e1120/73908/Providing-Psychosocial-Support-to-Children-and

Providing Psychosocial Support to Children and Families ... This clinical report provides practical suggestions on how to identify common adjustment difficulties in children in the aftermath of a disaster.