Road-to-Recovery: web support for families after a child's traumatic brain injury
Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery, A Randomized Control Trial
This project will try a web-based Road-to-Recovery program to help caregivers of children (3 months–18 years) recovering from complicated mild to severe traumatic brain injury, compared with usual medical care plus online resources.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT05622461 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial compares usual medical care plus internet resources (IRC) to usual care plus the web-based Road-to-Recovery (R2R-TBI) intervention for caregivers. Caregivers will be randomized to one of the two groups and complete measures at baseline, one month, and six months post-randomization. The R2R-TBI program targets parental self-care, positive parent–child interactions, and awareness of potential longer-term behavioral and psychosocial concerns and is delivered via any web-enabled device with optional tablet access in outpatient settings. The trial enrolls English-speaking caregivers of children aged 3 months to 18 years who were hospitalized overnight for complicated mild to severe TBI and are within 0–3 months post-discharge.
Who should consider this trial
Good fit: Ideal participants are English-speaking caregivers aged 18 or older who live with a child aged 3 months to 18 years hospitalized overnight for a complicated mild to severe TBI (per GCS/imaging criteria) and who are 0–3 months post-discharge.
Not a fit: Caregivers of children who did not survive, who sustained non-blunt injuries (e.g., gunshot wounds), who do not live with the child for the study duration, who are not English-speaking, who are beyond three months post-discharge, or who cannot access/participate in the program are unlikely to benefit.
Why it matters
Potential benefit: If successful, the program could reduce caregiver stress, improve parent–child interactions, and help identify and address children's behavioral and psychosocial needs earlier, potentially improving child recovery.
How similar studies have performed: Web-based caregiver and parent-focused interventions for pediatric chronic conditions have shown benefits for caregiver mental health and parenting, but R2R-TBI is a tailored program for pediatric TBI with limited prior randomized evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Shari Wade, PhD — Cchmc
- Study coordinator: Shari Wade, PhD
- Email: Shari.Wade@cchmc.org
- Phone: 5134610952
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.