Traumatic Brain InjuryNCT05622461
Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery
A study testing Road-to-recovery in people with Traumatic Brain Injury and Head Injury, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Head Injury, Head Injuries, Closed
- What is being tested?
- Road-to-recovery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2023to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stacey Raj contact
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3036
Shari Wade, 5134610952, Shari.Wade@cchmc.org
Stacey Raj, rajs@xavier.edu
About this study
Official title: Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery, A Randomized Control Trial
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).
Read the detailed description
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.
- Conditions
- Traumatic Brain Injury, Head Injury, Head Injuries, Closed, Brain Hemorrhage, Traumatic, Brain Edema, Intracranial Edema
- Being tested
- Road-to-recovery
- Medical subject headings
- Brain Injuries, Traumatic, Craniocerebral Trauma, Head Injuries, Closed, Brain Hemorrhage, Traumatic, Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Road-to-recoveryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Road-to-recovery group (R2R) | Experimental | Usual medical care plus the R2R-TBI intervention (self-guided web-program) Receives: Behavioral: Road-to-recovery |
| Internet resources comparison group (IRC) | Active comparator | Usual medical care plus internet resources Receives: Behavioral: Road-to-recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline at 6 months
Secondary outcomes (10)
Family Functioning
Family Assessment Device - Global Functioning Scale. Scores range from 1 to 4 with higher scores indicating poorer family functioning
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Change from baseline at 6 months
Parent resilience
Connor-Davidson Resilience Scale (CDRI); scores range from 0-40 with higher scored indicating greater resilience
Measured: 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
Measured: Change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start13 Feb 2023
- Primary completion1 Mar 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Shari Wade, PhD, Principal investigator, CCHMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622461
- Sponsor's protocol ID
- 2022-0221
- Status last verified
- Jun 2025
- First submitted
- 24 Oct 2022
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan is to share deidentified data as consistent with requirement of funding source (i.e., The National Institute on Disability and Rehabilitation Research).
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery, A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05622461
- Acronym / sponsor ID
- 2022-0221
- Conditions
- Traumatic Brain Injury, Head Injury, Head Injuries, Closed, Brain Hemorrhage, Traumatic, Brain Edema, Intracranial Edema
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Road-to-recovery group (R2R) | Experimental | Behavioral: Road-to-recoveryUsual medical care plus the R2R-TBI intervention (self-guided web-program) |
| Internet resources comparison group (IRC) | Active comparator | Behavioral: Road-to-recoveryUsual medical care plus internet resources |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Road-to-recoveryR2R-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. | Behavioural | Internet resources comparison group (IRC), Road-to-recovery group (R2R) |
Primary outcome
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
10 secondary outcomes
Family Functioning
Time frame: Change from baseline at 4-6 weeks post-intervention
Family Functioning
Time frame: Change from baseline at 6 months
Family Burden of Injury
Time frame: Change from baseline at 4-6 weeks post-intervention
Family Burden of Injury
Time frame: Change from baseline at 6 months
Child Socioemotional Functioning
Time frame: Change from baseline at 4-6 weeks post-intervention
Child Socioemotional Functioning
Time frame: Change from baseline at 6 months
Parent mindful self-care
Time frame: Change from baseline at 4-6 weeks post-intervention
Parent mindful self-care
Time frame: Change from baseline at 6 months
Parent resilience
Time frame: Change from baseline at 4-6 weeks post-intervention
Parent resilience
Time frame: Change from baseline at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Yes. Plan is to share deidentified data as consistent with requirement of funding source (i.e., The National Institute on Disability and Rehabilitation Research).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stacey Raj contact
Shari Wade, PhD principal investigator
CCHMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Road-to-recovery in people with Traumatic Brain Injury and Head Injury, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shari Wade, PhD (5134610952, Shari.Wade@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent anxiety (time frame: Change from baseline at 4-6 weeks post-intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.