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Recruiting NCT05622461

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

Trial Parameters

Condition Traumatic Brain Injury
Sponsor Children's Hospital Medical Center, Cincinnati
Study Type INTERVENTIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-02-13
Completion 2026-03-01
Interventions
Road-to-recovery

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

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