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Road-to-Recovery Program for Traumatic Brain Injury
N/A
Recruiting
Led By Shari Wade, PhD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
0-3 months post-discharge
Child aged 3 months to 18 years at time of discharge from hospital
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will study the effectiveness of a new TBI intervention vs. usual medical care plus online resources. Two groups will be compared with follow-up assessments.
Who is the study for?
This trial is for caregivers over 18 with a child aged 3 months to 18 years who's been hospitalized due to mild to severe TBI, including brain swelling or bleeding. The child must have stayed overnight in the hospital and be within 0-3 months post-discharge. Excluded are non-English speaking households, cases of non-blunt trauma like gunshot wounds, or if the child won't stay with the caregiver during the study.Check my eligibility
What is being tested?
The 'Road-to-Recovery' (R2R-TBI) intervention is being tested against usual medical care plus internet resources on pediatric brain injury. Participants will be randomly assigned to one of these two groups and evaluated at baseline, one month after randomization, and six months later.See study design
What are the potential side effects?
Since this trial involves an educational intervention rather than a drug treatment, traditional side effects are not applicable. However, there may be emotional or psychological impacts from participating in such programs that should be monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was discharged from the hospital within the last 3 months.
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My child is between 3 months and 18 years old at hospital discharge.
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My child was admitted to the hospital overnight.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anxiety
Parent depression
Parent post-traumatic symptoms
+1 moreSecondary outcome measures
Child Socioemotional Functioning
Traumatic injury
Family Functioning
+2 moreOther outcome measures
Moderators of treatment effects
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Road-to-recovery group (R2R)Experimental Treatment1 Intervention
Usual medical care plus the R2R-TBI intervention (self-guided web-program)
Group II: Internet resources comparison group (IRC)Active Control1 Intervention
Usual medical care plus internet resources
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Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,391 Total Patients Enrolled
Nationwide Children's HospitalOTHER
341 Previous Clinical Trials
5,220,306 Total Patients Enrolled
Shari Wade, PhDPrincipal InvestigatorCCHMC
2 Previous Clinical Trials
157 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- English is not the main language spoken in my home.My child is between 3 months and 18 years old at hospital discharge.A child had a head injury with certain symptoms and test results, like changes in brain imaging or a certain score on a test called the Glasgow Coma Scale.I was discharged from the hospital within the last 3 months.I am a caregiver and I am over 18 years old.My child was admitted to the hospital overnight.The child passed away due to the injury.A child has experienced a head injury that was not caused by a blunt force (like a fall or a bump).
Research Study Groups:
This trial has the following groups:- Group 1: Road-to-recovery group (R2R)
- Group 2: Internet resources comparison group (IRC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings within this research endeavor?
"Per the information provided on clinicaltrials.gov, enrollment for this medical trial is still open. The first posting date was February 13th 2023 and the last update occurred on May 31st of that same year."
Answered by AI
How many individuals are being recruited to participate in this clinical trial?
"Affirmative, there is an open call for participants in the trial as revealed by clinicaltrials.gov. It was first listed on February 13th 2023 and last amended May 31st of that same year. The goal is to find 200 individuals from a single research centre."
Answered by AI
What do researchers hope to achieve through this clinical experiment?
"The primary assessment of this trial is the parent's depression score measured at 6 months from baseline. Secondary outcomes include Family Burden of Injury Interview (FBII) with scores ranging 0-4, Pediatric Quality of Life Scale for Child Socioemotional Functioning, and Mindful self-care scale (MSCS) to measure Parent mindful self-care; all higher scores indicate greater health efficacy."
Answered by AI
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