RecruitingNot ApplicableNCT05622461

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

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


Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

200 participants

Start Date

Feb 13, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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
  • months post-discharge

Exclusion Criteria5

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALRoad-to-recovery

R2R-TBI is a self-guided web-based intervention that targets caregiver psychological functioning, parenting behaviors, and family functioning in the first three months following pediatric traumatic brain injury.


Locations(1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05622461


Related Trials