Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery (NCT05622461) | Clinical Trial Compass
RecruitingNot Applicable
Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery
United States200 participantsStarted 2023-02-13
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Parent anxiety
Timeframe: Change from baseline at 4-6 weeks post-intervention
2
Parent anxiety
Timeframe: Change from baseline at 6 months
3
Parent depression
Timeframe: Change from baseline at 4-6 weeks post-intervention
4
Parent depression
Timeframe: Change from baseline at 6 months
5
Parenting self-efficacy
Timeframe: Change from baseline at 4-6 weeks post-intervention
6
Parenting self-efficacy
Timeframe: Change from baseline at 6 months
7
Parent post-traumatic symptoms
Timeframe: Change from baseline at 4-6 weeks post-intervention
8
Trial details
NCT IDNCT05622461
SponsorChildren's Hospital Medical Center, Cincinnati