Road-to-Recovery Program for Traumatic Brain Injury

Overseen By Stacey Raj

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Child deceased, Non-blunt trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4-6 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new program called Road-to-Recovery, designed to help children recover more effectively from traumatic brain injury (TBI). Researchers aim to compare the effectiveness of this program against standard medical care and online resources. The trial includes two groups: one will use the Road-to-Recovery web program alongside usual care, while the other will receive only usual care and access to internet resources. It suits caregivers of children who recently left the hospital after a complicated mild to severe TBI and are within three months of discharge. As an unphased trial, this study provides caregivers a unique chance to contribute to innovative research that could improve recovery options for children with TBI.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems like you can continue your usual medical care while participating.

What prior data suggests that the Road-to-Recovery program is safe for traumatic brain injury patients?

Research has shown that the Road-to-Recovery (R2R) program for traumatic brain injury (TBI) has been tested in previous studies to ensure ease of use and safety. The program is user-friendly and beneficial without causing harm. As a self-guided web program, R2R generally has fewer side effects than traditional medical treatments. Research has reported no negative effects, suggesting participants handle the program well.

Being an online program, it aids recovery by providing education and resources. This type of treatment typically carries a very low safety risk. However, individual experiences can vary, so participants should discuss any concerns with their healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Road-to-Recovery program for traumatic brain injury because it offers a unique, self-guided web-based intervention. Unlike traditional rehabilitation methods that often require in-person therapy sessions, this program provides flexibility and accessibility, allowing patients to engage with the treatment at their own pace and from the comfort of their home. By integrating usual medical care with a digital platform, it aims to enhance recovery outcomes through interactive, personalized content that can be tailored to individual needs. This innovative approach could potentially revolutionize recovery by making high-quality resources more widely available and convenient for patients.

What evidence suggests that the Road-to-Recovery program is effective for traumatic brain injury?

Research has shown that the Road-to-Recovery (R2R) program for traumatic brain injury (TBI) appears promising. Early results from small studies indicate that this self-guided, online program can help families adjust positively after a child experiences a brain injury. In this trial, participants in the Road-to-Recovery group will receive usual medical care plus the R2R-TBI intervention. The program supports caregivers, who play a crucial role in the recovery process, especially immediately after the injury. Families who used the program reported that it helped them better manage the challenges of a child's brain injury. These early findings suggest that R2R might effectively aid recovery by providing practical tools and resources. ^{1 2 6 7 8}

Who Is on the Research Team?

Shari Wade, PhD

Principal Investigator

CCHMC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion Criteria

English is not the main language spoken in my home.

Child does not reside with parent/caregiver for study duration

The child passed away due to the injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the R2R-TBI intervention or access to internet resources for 4-6 weeks

4-6 weeks

Web-based access, optional in-person access during outpatient therapies

Follow-up

Participants are monitored for changes in parenting self-efficacy, anxiety, depression, and other outcomes

6 months

Assessments at 1 month and 6 months post-randomization

What Are the Treatments Tested in This Trial?

Interventions

• Road-to-recovery

Trial Overview 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.

How Is the Trial Designed?

Group I: Road-to-recovery group (R2R) Experimental Treatment 1 Intervention

Usual medical care plus the R2R-TBI intervention (self-guided web-program)

Group II: Internet resources comparison group (IRC) Active Control 1 Intervention

Usual medical care plus internet resources

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Nationwide Children's Hospital

Collaborator

Trials

354

Recruited

5,228,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05622461

Setting Families on a Positive Path to Recovery After ... 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 ...

2. dam.assets.ohio.gov dam.assets.ohio.gov/image/upload/ems.ohio.gov/links/R2R_TBI.pdf

Final Grant Report Promoting Positive Family Adaptation ... The aim of this pilot study was to develop and conduct usability testing of a self-guided responsive web design (RWD) program, i.e., the Road to Recovery for ...

3. withpower.com withpower.com/trial/road-to-recovery-program-for-traumatic-brain-injury-16882

Road-to-Recovery Program for Traumatic Brain Injury 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 ...

4. trialx.com trialx.com/clinical-trials/listings/235400/setting-families-on-a-positive-path-to-recovery-after-pediatric-tbi-road-to-recovery/

Setting Families on a Positive Path to Recovery After ... 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 ...

5. researchgate.net researchgate.net/publication/353939508_Road-to-recovery-TBI_Pilot_trial_of_an_eHealth_intervention_for_caregivers_after_pediatric_brain_injury

Road-to-Recovery-TBI: Pilot Trial of an eHealth ... We developed and pilot tested road-to-recovery-TBI (R2R-TBI), a self-guided, eHealth intervention to support caregivers during the acute phase following ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10427240/

Traumatic brain injury: progress and challenges in prevention ... A major research challenge is to identify patients at risk for incomplete recovery early after mild TBI to facilitate timely intervention to improve outcome.

7. cdc.gov cdc.gov/traumaticbraininjury/pdf/tbi_report_to_congress_epi_and_rehab-a.pdf

Traumatic Brain Injury In the United States: Epidemiology ... For persons living with TBI-related health effects, rehabilitation goals are structured to improve their independence in activities of daily living, social ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10947151/

The BETTER Traumatic Brain Injury Transitional Care ... Overall and mental QOL scores did not differ over time but physical QOL scores did improve over time (baseline: 30.3, 8-weeks: 46.5, 16-weeks: ...