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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT05622461
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Road-to-recovery — BEHAVIORAL
    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.

Study Details

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).

Key Dates

Start date
Feb 13, 2023
Status verified
Jun 2025
Primary completion
Mar 1, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Parent anxiety [ Time Frame: Change from baseline at 4-6 weeks post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-3036
Shari Wade
[email protected]
5134610952
Stacey Raj
[email protected]

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Cincinnati Children's Hospital Medical Center· Cincinnati, OH

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