NCT05622461 · Children's Hospital Medical Center, Cincinnati
Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery
What this study is about
This study has two main goals: 1) to refine and enhance the R2R-TBI intervention; and 2) to examine the effectiveness of the R2R-TBI intervention in a randomly assigned control trial. To achieve the second goal, we will employ a between-groups randomly assigned treatment design with repeated measures at baseline, one-month post-randomization, and at a six-month follow-up.
View original scientific description
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).
Interventions
BEHAVIORAL
Road-to-recovery
R2R-TBI is a self-guided web-based intervention that targets caregiver psychological functioning, parenting behaviors, and family functioning in the first three months following pediatric traumatic brain injury.
Primary outcome measures
Parent anxiety
Time frame: Change from baseline at 4-6 weeks post-intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure 4a; scores range from 4-20 with higher score indicating greater symptoms of anxiety
Parent anxiety
Time frame: Change from baseline at 6 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure 4a; scores range from 4-20 with higher score indicating greater symptoms of anxiety
Parent depression
Time frame: Change from baseline at 4-6 weeks post-intervention
Center for Epidemiological Studies Depression Scale (CES-D; 10-items); scores range from 0 -30 with higher scores indicating of higher levels of depressive symptomatology
Parent depression
Time frame: Change from baseline at 6 months
Center for Epidemiological Studies Depression Scale (CES-D; 10-items); scores range from 0 -30 with higher scores indicating of higher levels of depressive symptomatology
Parenting self-efficacy
Time frame: Change from baseline at 4-6 weeks post-intervention
Caregiver self-efficacy scale (CSES); scores range from 25-100, higher scores indicate greater parenting self efficacy
Parenting self-efficacy
Time frame: Change from baseline at 6 months
Caregiver self-efficacy scale (CSES); scores range from 25-100, higher scores indicate greater parenting self efficacy
Parent post-traumatic symptoms
Time frame: Change from baseline at 4-6 weeks post-intervention
Primary Care PTSD Screen for DSM-5 (PC-PTSD-5); scores rage from 0-5 with higher scores indicating greater experience of post-traumatic stress symptoms
Parent post-traumatic symptoms
Time frame: Change from baseline at 6 months
Primary Care PTSD Screen for DSM-5 (PC-PTSD-5); scores rage from 0-5 with higher scores indicating greater experience of post-traumatic stress symptoms
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Cincinnati, Ohio
Collaborators
Nationwide Children's Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2025 · Source of record for eligibility and locations