mHealth CAARE Program for Traumatic Injury Recovery

LR
Overseen ByLeigh Ridings, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to create and test a support program called Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) to assist families with children hospitalized due to traumatic injuries. The program focuses on improving the emotional and behavioral well-being of both children and their caregivers. It targets caregivers of children under 12 who have experienced an accident or other traumatic event and who speak English. Families dealing with injuries from self-harm or abuse are not eligible. The goal is to develop a model that trauma centers can use to enhance family support and recovery. As an unphased trial, this study allows families to contribute to developing a new support model that could benefit many others in similar situations.

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.

What prior data suggests that the CAARE program is safe for families?

Research has shown that the Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) program helps children and their caregivers emotionally heal after a traumatic injury. Studies have found that caregivers play a crucial role in children's recovery, and this program aims to strengthen that support.

Regarding safety, no specific reports of problems have emerged from using CAARE. The program has been developed and tested on a small scale to ensure it is safe and helpful. Since it focuses on emotional and behavioral support rather than medication, the risks are generally lower compared to medical treatments.

Overall, CAARE is designed to assist families without significant safety concerns. It aims to improve quality of life and emotional health, and initial evaluations have shown positive results.12345

Why are researchers excited about this trial?

Researchers are excited about the mHealth CAARE Program because it offers a novel approach to supporting recovery from pediatric traumatic injuries by directly involving caregivers in the healing process. Unlike traditional treatments that focus solely on medical interventions for the child, this program emphasizes empowering families to actively participate in their child's recovery journey. By using mobile health (mHealth) technology, CAARE provides accessible, real-time support and resources to caregivers, which could lead to improved recovery outcomes and reduced stress for both children and their families. This innovative method not only targets the physical aspects of recovery but also addresses the emotional and psychological needs, offering a more holistic approach than typical medical care.

What evidence suggests that the CAARE program is effective for traumatic injury recovery?

Research has shown that about one in three children develop symptoms of PTSD (post-traumatic stress disorder) and depression after a traumatic injury. Additionally, more than half of their caregivers experience high levels of stress and PTSD. In this trial, families will receive the Caregivers' Aid to Accelerate Recovery after Pediatric Emergencies (CAARE) program, designed to address these emotional and behavioral challenges. The program supports both children and their caregivers, which is crucial since many trauma centers primarily focus on physical recovery. This approach can enhance the quality of life and emotional well-being for families dealing with children's injuries.23678

Are You a Good Fit for This Trial?

This trial is for caregivers over 18 and children under 12 who have experienced a traumatic injury. Caregivers must speak English and the injuries should not be self-inflicted or due to caregiver abuse/neglect.

Inclusion Criteria

I am under 12 years old.
I am a caregiver and I am over 18 years old.
You are taking care of a child who has been injured severely.

Exclusion Criteria

The person who takes care of you does not speak English as their main language.
You have intentionally harmed yourself.
You have injuries caused by someone who was supposed to take care of you, but didn't.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Model Finalization and Usability Testing

Finalization of the CAARE model and usability testing with caregivers to refine mHealth components

4-6 weeks

Open Trial

Implementation of the full CAARE intervention with families to evaluate its effectiveness

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)
Trial Overview The study is testing CAARE, a program designed to help caregivers and their injured children recover emotionally after trauma. It aims to improve mental health outcomes and quality of life post-injury.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Families receiving interventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

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

Collaborator

Trials
2,103
Recruited
2,760,000+

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 ...
Behavioral Health Intervention for Pediatric InjuryThis N/A medical study run by Medical University of South Carolina is evaluating whether Caregivers' Aid to Accelerate Recovery after pediatric Emergencies ...
Caregivers' and Young Children's Emotional Health Needs ...Pediatric traumatic injury (PTI) is associated with emotional health difficulties, but most US trauma centers do not adequately address emotional recovery needs ...
Comparing Two Approaches to Improve Families ...In this study, the research team compared two approaches to provide care for children with traumatic injuries arriving at a non-pediatric ...
Improving Quality of Life and Behavioral Health Service ...This proposal builds on evidence from an NICHD K23 to develop and pilot CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies), a technology ...
Program at MUSC addresses mental health following ...Trauma Resilience and Recovery Program helps curb PTSD and depression after traumatic injury.
Family caregiver perspectives on strengths and challenges in ...The purpose of this study was to identify family member caregiver perspectives on strengths and challenges in pediatric injury care throughout hospitalization.
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