RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study has two main goals: 1) to refine and enhance the R2R-TBI intervention; and 2) to examine the efficacy of the R2R-TBI intervention in a randomized control trial. To achieve the second goal, we will employ a between-groups randomized treatment design with repeated measures at baseline, one-month post-randomization, and at a six-month follow-up. The two conditions will be: a) usual medical care plus access to internet resources regarding pediatric brain injury (Internet Resources Comparison group, IRC), and b) usual medical care plus the R2R-TBI intervention (Road-to-Recovery group, R2R-TBI).

Official Title

Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery, A Randomized Control Trial

Quick Facts

Study Start:2023-02-13
Study Completion:2024-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05622461

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages 3 months to 18 years at time of discharge from hospital
  2. * 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
  3. * Admitted overnight to the hospital
  4. * 0-3 months post-discharge
  1. * Child did not survive the injury
  2. * Child sustained a non-blunt head trauma (e.g. gunshot wound)
  3. * Child does not reside with parent/caregiver for study duration
  4. * English is not primary language spoken in the home

Contacts and Locations

Study Contact

Shari Wade, PhD
CONTACT
5134610952
Shari.Wade@cchmc.org
Stacey Raj
CONTACT
rajs@xavier.edu

Principal Investigator

Shari Wade, PhD
PRINCIPAL_INVESTIGATOR
CCHMC

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3036
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Shari Wade, PhD, PRINCIPAL_INVESTIGATOR, CCHMC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-13
Study Completion Date2024-10-30

Study Record Updates

Study Start Date2023-02-13
Study Completion Date2024-10-30

Terms related to this study

Additional Relevant MeSH Terms

  • Traumatic Brain Injury
  • Head Injury
  • Head Injuries, Closed
  • Brain Hemorrhage, Traumatic
  • Brain Edema
  • Intracranial Edema