Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Road-to-Recovery: web support for families after a child's traumatic brain injury

Official title: Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery, A Randomized Control Trial

Run by Children's Hospital Medical Center, Cincinnati · NCT05622461 · Data updated 2026-11-12

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.

More Traumatic Brain Injury trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorChildren's Hospital Medical Center, Cincinnati
Academic / other
Locations1 site (Cincinnati, Ohio)
StatusRecruiting
StartedFebruary 13, 2023
Main results expectedMarch 1, 2026
Study endsAugust 31, 2026
Registry record updatedJune 25, 2025
Trial IDNCT05622461 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.