NCT05622461 Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery
| NCT ID | NCT05622461 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-02-13 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-02-13 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Shari Wade, PhD
PRINCIPAL INVESTIGATOR
CCHMC
Frequently Asked Questions
Who can join the NCT05622461 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05622461 currently recruiting?
Yes, NCT05622461 is actively recruiting participants. Contact the research team at Shari.Wade@cchmc.org for enrollment information.
Where is the NCT05622461 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT05622461 clinical trial?
NCT05622461 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Shari Wade, PhD at CCHMC. The trial plans to enroll 200 participants.