Recruiting

R2R-TBI

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT05622461

Conditions

Traumatic Brain Injury

Head Injury

Head Injuries, Closed

Brain Hemorrhage, Traumatic

Brain Edema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Road-to-recovery

Study Details

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).

Conditions

Traumatic Brain Injury

Head Injury

Head Injuries, Closed

Brain Hemorrhage, Traumatic

Brain Edema

Study ID

NCT05622461

Start date

Feb 13, 2023

Status verified date

Jun, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Road-to-recovery group (R2R)

Usual medical care plus the R2R-TBI intervention (self-guided web-program)

active comparator: Internet resources comparison group (IRC)

Usual medical care plus internet resources

Interventions

Road-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.

Primary outcome measure

  • Parent anxiety [ Time Frame: Change from baseline at 4-6 weeks post-intervention ]
  • Parent anxiety [ Time Frame: Change from baseline at 6 months ]
  • Parent depression [ Time Frame: Change from baseline at 4-6 weeks post-intervention ]
  • Parent depression [ Time Frame: Change from baseline at 6 months ]
  • Parenting self-efficacy [ Time Frame: Change from baseline at 4-6 weeks post-intervention ]
  • Parenting self-efficacy [ Time Frame: Change from baseline at 6 months ]
  • Parent post-traumatic symptoms [ Time Frame: Change from baseline at 4-6 weeks post-intervention ]
  • Parent post-traumatic symptoms [ Time Frame: Change from baseline at 6 months ]

Central Contacts and Locations

Central contacts

Shari Wade, PhD

5134610952Shari.Wade@cchmc.org

Stacey Raj

rajs@xavier.edu

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229-3036

Contacts

Shari Wade

5134610952Shari.Wade@cchmc.org

Stacey Raj

rajs@xavier.edu

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Jun 25, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2025-06-25.