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Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Nov 14, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial, called "Road-to-Recovery," is designed to help families of children who have suffered a traumatic brain injury (TBI) find better ways to support their recovery. The study has two main goals: first, to improve the support program called R2R-TBI, and second, to see how effective this program is in helping families compared to just accessing information online about brain injuries. Families will be randomly assigned to one of two groups: one will receive the usual medical care along with the R2R-TBI program, while the other will receive usual care plus online resources. Researchers will check in with participants at the start of the study, one month later, and again six months later to see how things are going.

To participate in this trial, caregivers need to be over 18 years old and have a child between 3 months and 18 years who was hospitalized after a serious brain injury. The child must have had a complicated TBI, meaning they showed certain signs of injury during their hospital stay. However, this study is not open to families whose child did not survive the injury or those whose child experienced specific types of head trauma, like a gunshot wound. Participants can expect to be part of an important research project that aims to improve recovery for children with brain injuries, while also gaining access to valuable resources and support for their family.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Caregivers will be eligible if they are over 18 years of age, and if their child meets all of the following criteria:
  • Ages 3 months to 18 years at time of discharge from hospital
  • Sustained a complicated mild to severe TBI as defined by a Glasgow Coma Scale (GCS) of 13-15 with imagining abnormalities or GCS 3-12 with or without imaging abnormalities
  • Admitted overnight to the hospital
  • 0-3 months post-discharge
  • Exclusion Criteria:
  • The caregiver will be excluded from participation if any of the following occur:
  • Child did not survive the injury
  • Child sustained a non-blunt head trauma (e.g. gunshot wound)
  • Child does not reside with parent/caregiver for study duration
  • English is not primary language spoken in the home

About Children's Hospital Medical Center, Cincinnati

Children's Hospital Medical Center in Cincinnati is a leading pediatric healthcare institution dedicated to advancing child health through innovative clinical research and comprehensive patient care. Renowned for its commitment to excellence, the center conducts a wide range of clinical trials aimed at developing and evaluating new treatments and therapies for pediatric populations. With a focus on multidisciplinary collaboration and ethical research practices, Children's Hospital Medical Center strives to improve health outcomes for children while contributing to the broader scientific understanding of pediatric medicine.

Locations

Cincinnati, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Shari Wade, PhD

Principal Investigator

CCHMC

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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