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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
No Placebo-Only Group

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.
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.
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 below
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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 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Anxiety
Parent depression
Parent post-traumatic symptoms
+1 more
Secondary study objectives
Child Socioemotional Functioning
Traumatic injury
Family Functioning
+2 more
Other study objectives
Moderators of treatment effects

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
839 Previous Clinical Trials
6,565,403 Total Patients Enrolled
Nationwide Children's HospitalOTHER
348 Previous Clinical Trials
5,227,610 Total Patients Enrolled
Shari Wade, PhDPrincipal InvestigatorCCHMC
2 Previous Clinical Trials
157 Total Patients Enrolled

Media Library

Road-to-recovery Clinical Trial Eligibility Overview. Trial Name: NCT05622461 — N/A
Brain Swelling Research Study Groups: Road-to-recovery group (R2R), Internet resources comparison group (IRC)
Brain Swelling Clinical Trial 2023: Road-to-recovery Highlights & Side Effects. Trial Name: NCT05622461 — N/A
Road-to-recovery 2023 Treatment Timeline for Medical Study. Trial Name: NCT05622461 — N/A
~71 spots leftby Dec 2025
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