Behavioral Health Intervention for Pediatric Injury
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.12345Why 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.12467
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the CAARE intervention, which includes bedside screening, digital health tools, and follow-up for behavioral health management
Follow-up
Participants are monitored for safety and effectiveness after treatment, with 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?
2
Treatment groups
Experimental Treatment
Active Control
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.
Educational packet includes behavioral health education for children and families after pediatric traumatic injury(PTI).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Citations
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 ...
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 ...
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-injuryProgram at MUSC addresses mental health following ...
Trauma Resilience and Recovery Program helps curb PTSD and depression after traumatic injury.
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 ...
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-andProviding 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.
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