mHealth CAARE Program for Traumatic Injury Recovery

Overseen By Leigh Ridings, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Non-English speakers, Self-afflicted injury, Abuse, others

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

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Nearly 300,000 U.S. children experience injuries that require them to be hospitalized this year. These children, and their caregivers, are at high risk for emotional and behavioral problems, as well as poor quality of life. Trauma centers in the US have good outcomes for survival and physical recovery, but they typically do not have programs to address the emotional and behavioral needs of families. The purpose of this project is to develop a service that achieves this and that can serve as a good model for trauma centers to use. This project will develop, evaluate, and test CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies) to address the behavioral and emotional needs of caregivers and children.

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 data supports the effectiveness of the mHealth CAARE Program for Traumatic Injury Recovery treatment?

The study on improved concussion discharge instructions in a pediatric emergency department showed that providing caregivers with enhanced written materials increased their understanding of injury management by 24%. This suggests that better caregiver education, a component likely included in the CAARE program, can improve recovery outcomes for children after traumatic injuries. ^{1 2 3 4 5}

How is the mHealth CAARE Program for Traumatic Injury Recovery different from other treatments for pediatric trauma recovery?

The mHealth CAARE Program is unique because it uses a mobile health approach to support caregivers in accelerating recovery after pediatric emergencies, focusing on caregiver training and support through web-based and telehealth methods, which is not commonly emphasized in traditional treatments. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Families receiving intervention Experimental Treatment 1 Intervention

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Improved Concussion Discharge Instructions in a Pediatric Emergency Department. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Tools for the measurement of outcome after minor head injury in children: summary from the Ambulatory Pediatric Association/EMSC Outcomes Research Conference. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Improving Timeliness of Pediatric Emergency Department Admissions. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Benefits of strict rest after acute concussion: a randomized controlled trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Research Agenda to Advance Pediatric Emergency Care Through Enhanced Collaboration Across Emergency Departments. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

A web-based videoconferencing approach to training caregivers in rural areas to compensate for problems related to traumatic brain injury. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

A Telehealth Approach to Caregiver Self-Management Following Traumatic Brain Injury: A Randomized Controlled Trial. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Experiences from the development of a comprehensive family support program for pediatric trauma and rehabilitation patients. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a web-based early intervention for children and their parents following unintentional injury. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Families of children with traumatic injuries identify needs for research and training. [2014]