Road-to-Recovery for Families After Pediatric Traumatic Brain Injury

This study is testing a web-based program called "Road-to-Recovery (R2R-TBI)" for families of children who have had a traumatic brain injury (TBI). The program aims to help caregivers with their psychological well-being, parenting skills, and overall family functioning in the first three months after their child's injury. You might be able to join if you are a caregiver over 18 and your child, aged 3 months to 18 years, had a complicated mild to severe TBI and was admitted to the hospital overnight. The study will look at how the R2R-TBI program affects parent anxiety and depression over 6 months. This study is currently unclear on its recruitment status and plans to enroll 200 participants.

Study design
This study is an interventional, randomized controlled trial comparing usual medical care plus internet resources to usual medical care plus the R2R-TBI program. It aims to enroll 200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after the intervention to measure parent anxiety and depression.

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NCT05622461

Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery

Recruiting
NAAges 18+InterventionalTreatment
Children's Hospital Medical Center, Cincinnati
~200 participants
Updated 2025-06-25 on ClinicalTrials.gov
What's tested:Road-to-recovery

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Parent anxiety
Measured over Change from baseline at 4-6 weeks post-intervention
+7 more outcomes measured
Traumatic Brain Injury
Head Injury
Head Injuries, Closed
Brain Hemorrhage, Traumatic
Brain Edema
Intracranial Edema
1 sites across 1 states
Ohio1
  • Shari Wade, PhD · PRINCIPAL_INVESTIGATOR · CCHMC

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Eligibility criteria

Inclusion

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

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
  • Parent anxietyChange 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 anxietyChange 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 depressionChange 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 depressionChange 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-efficacyChange 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-efficacyChange 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 symptomsChange 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 symptomsChange 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