An interventional study of Road-to-recovery in Traumatic Brain Injury, Head Injury and Head Injuries, Closed, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-25.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment
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).
The early recovery period constitutes a critical window to set families on a positive road-to-recovery by supporting parental self-care, positive parent-child interactions, and awareness of potential longer-term concerns. The latter would facilitate parental recognition of behavioral and psychosocial needs that might otherwise go unmet.
Recognizing that (1) caregivers of children who have sustained TBI are at risk of worsening psychological health and that (2) caregiver functioning and parenting behaviors have a direct impact on child recovery and outcomes; intervening and supporting caregivers in the acute phase following injury may set children and families on a positive path to recovery. Intervening at the acute phase may reduce the cascading effects of parental burden/distress and concomitant negative parent-child interactions on child recovery and functioning over time.
Because families of children with TBI and other chronic health conditions may have difficulty accessing services due to transportation and cost issues, particularly lower income families, the R2R-TBI program is designed to be accessed via any web-enabled device (e.g., smartphone, computer, tablet) with any form of internet connection. We will also offer the intervention (via tablet) to parents while they wait for their child to complete outpatient therapies (e.g., speech, physical, and occupational therapy). Delivery of web-based behavioral health interventions may reduce barriers to help-seeking and promote evidence-based interventions that are both accessible and efficient.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 200 is above the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Caregivers will be eligible if they are over 18 years of age, and if their child meets all of the following criteria:
Exclusion Criteria:
The caregiver will be excluded from participation if any of the following occur:
Usual medical care plus the R2R-TBI intervention (self-guided web-program)
Behavioral: Road-to-recovery
Usual medical care plus internet resources
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.
Parent anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure 4a; scores range from 4-20 with higher score indicating greater symptoms of anxiety
Time frame: Change from baseline at 4-6 weeks post-intervention
Parent anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure 4a; scores range from 4-20 with higher score indicating greater symptoms of anxiety
Time frame: Change from baseline at 6 months
Parent depression
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
Time frame: Change from baseline at 4-6 weeks post-intervention
Parent depression
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
Time frame: Change from baseline at 6 months
Parenting self-efficacy
Caregiver self-efficacy scale (CSES); scores range from 25-100, higher scores indicate greater parenting self efficacy
Time frame: Change from baseline at 4-6 weeks post-intervention
Parenting self-efficacy
Caregiver self-efficacy scale (CSES); scores range from 25-100, higher scores indicate greater parenting self efficacy
Time frame: Change from baseline at 6 months
Parent post-traumatic symptoms
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
Time frame: Change from baseline at 4-6 weeks post-intervention
Parent post-traumatic symptoms
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
Time frame: Change from baseline at 6 months
Family Functioning
Family Assessment Device - Global Functioning Scale. Scores range from 1 to 4 with higher scores indicating poorer family functioning
Time frame: Change from baseline at 4-6 weeks post-intervention
Family Functioning
Family Assessment Device - Global Functioning Scale. Scores range from 1 to 4 with higher scores indicating poorer family functioning
Time frame: Change from baseline at 6 months
Family Burden of Injury
Family Burden of Injury Interview (FBII). Average scores range from 0-4; higher scores indicate greater injury-related burden
Time frame: Change from baseline at 4-6 weeks post-intervention
Family Burden of Injury
Family Burden of Injury Interview (FBII). Average scores range from 0-4; higher scores indicate greater injury-related burden
Time frame: Change from baseline at 6 months
Child Socioemotional Functioning
Pediatric Quality of Life Scale (PEDS-QL) - Psychosocial Health Summary Score (score range varies based on child age; higher scores indicate greater health related quality of life)
Time frame: Change from baseline at 4-6 weeks post-intervention
Child Socioemotional Functioning
Pediatric Quality of Life Scale (PEDS-QL) - Psychosocial Health Summary Score (score range varies based on child age; higher scores indicate greater health related quality of life)
Time frame: Change from baseline at 6 months
Parent mindful self-care
Mindful self-care scale (MSCS); scores range from 6 - 30, higher scores denote greater frequency in engaging in self-care behaviors
Time frame: Change from baseline at 4-6 weeks post-intervention
Parent mindful self-care
Mindful self-care scale (MSCS); scores range from 6 - 30, higher scores denote greater frequency in engaging in self-care behaviors
Time frame: Change from baseline at 6 months
Parent resilience
Connor-Davidson Resilience Scale (CDRI); scores range from 0-40 with higher scored indicating greater resilience
Time frame: Change from baseline at 4-6 weeks post-intervention
Parent resilience
Connor-Davidson Resilience Scale (CDRI); scores range from 0-40 with higher scored indicating greater resilience
Time frame: Change from baseline at 6 months
Moderators of treatment effects
Examining household income and baseline caregiver distress as moderator of treatment effects
Time frame: 4-6 weeks
Moderators of treatment effects
Examining household income and baseline caregiver distress as moderator of treatment effects
Time frame: 6 months
Plan to share: Yes — Plan is to share deidentified data as consistent with requirement of funding source (i.e., The National Institute on Disability and Rehabilitation Research).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Starting 6 months after publication
Access criteria: Plan is to share deidentified data as consistent with protocols of funding source (i.e., The National Institute on Disability and Rehabilitation Research).
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for Mar 2026, 36 months after the start.
Of 442 non-industry interventional studies with no phase under Brain Injuries, Traumatic, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 64. This study's planned 36 months is below that.
Counting every sponsor, half of 464 studies reached it within 40 months; a quarter within 22 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
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