Internet-based Interacting Together Everyday, Recovery After Childhood TBI (I-InTERACT)--RRTC (NCT01214694) | Clinical Trial Compass
CompletedNot Applicable
Internet-based Interacting Together Everyday, Recovery After Childhood TBI (I-InTERACT)--RRTC
United States117 participantsStarted 2009-10
Plain-language summary
The purpose of this study is to test two on-line interventions for families of young children who have experienced moderate or severe traumatic brain injury (TBI). This project builds upon the investigators' previous research by modifying the online intervention content to address the needs of young children with TBI. The goal of this project is to develop an intervention that will encourage positive parenting behaviors, improve child behaviors, and reduce parent distress and burden following TBI. The investigators hypothesize that the intervention groups will exhibit more effective parenting skills as well as better child functioning and lower levels of parental distress at follow-up than will the active comparison group.
Who can participate
Age range
3 Years – 9 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Moderate to severe TBI that occurred within the last 24 months
* Overnight hospital stay
* English-speaking
* Parent must be willing to provide informed consent
Exclusion Criteria:
* Child does not live with parents or guardian
* Child or parent has history of hospitalization for psychiatric problem
* Child suffered a non-blunt injury (e.g., projectile wound, stroke, drowning, or other form of asphyxiation)
* Diagnosed with moderate or severe mental retardation, autism, or a significant developmental disability
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focused on an internet-based program for families after childhood traumatic brain injury — since it's already completed, would my child's care team have access to any published results or findings from this study that could inform our treatment plan?
2The study measured outcomes through parent report measures, meaning parents were central to tracking recovery — how would my role as a caregiver factor into the rehabilitation approach my child's team is recommending, and are there similar family-focused programs available now?
3Since this was a non-drug, behavioral intervention delivered over the internet, are there any currently active or comparable online programs for supporting recovery after pediatric TBI that my family might be eligible for?
4This trial was specifically designed for children recovering from traumatic brain injury — given my child's age, injury severity, and current stage of recovery, would a program like this have been appropriate for us, and does something equivalent exist today?
5The study title mentions 'recovery' and family interaction as key themes — can you help me understand what the evidence says about how parental involvement and structured support programs affect long-term outcomes after childhood TBI?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Parent Report Measures
Timeframe: 5 years
Trial details
NCT IDNCT01214694
SponsorChildren's Hospital Medical Center, Cincinnati