An interventional study of Internet-based Interacting Together Everyday: Recovery After Childhood TBI and Internet Resources Comparison in Traumatic Brain Injury, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 3 Years to 9 Years. Per ClinicalTrials.gov, last updated 2014-10-28.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment
The purpose of this study is to test an on-line intervention for families of young children who have experienced moderate or severe traumatic brain injury (TBI). Previous interventions were not designed to address the needs of young children with TBI, and feedback revealed a desire for more examples and materials appropriate for families of younger children. 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 group 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.
Five million young children suffer from traumatic brain injury (TBI) each year resulting in new child behavior problems, parental distress, and family dysfunction. Recent studies provide evidence that online skill building interventions can reduce caregiver distress and improve child adjustment following TBI. The investigators hypothesize that the I-InTERACT group will exhibit more effective parenting skills as well as better child functioning and lower levels of parental distress at follow-up than will the IRC group. The investigators overarching goal is to reduce the risk of long-term behavioral problems and disability in young children following TBI by equipping parents with increased coping and parenting skills in a cost effective fashion. Findings will be disseminated via presentations and peer-reviewed publications, a website and newsletter, workshops with advocacy groups, and technical assistance to interested parties
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 41 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive the Internet resource comparison group treatment
Behavioral: Internet Resources Comparison
Participants will receive the internet-based parenting skills program.
Behavioral: Internet-based Interacting Together Everyday: Recovery After Childhood TBI
Families in I-InTERACT will look through 10 web-sessions (like chapters) and participate in 10 family meetings focusing on education about traumatic brain injury, parenting skills, communication, behavior strategies, and stress management. Meetings will be conducted in their home using a computer hook-up with a trained therapist. Families will also be contacted two times per month by the counselor to discuss individual problems or concerns.
Also known as: I-InTERACT
Families in the IRC group will receive computers, high speed internet access, and links to brain injury information and resources. The resources are available for families to access as often as they choose.
Also known as: IRC
Parent Self Report Measures
Time frame: 3 years
Videotaped parent-child interactions
Time frame: 3 years
Neuropsychological testing
Time frame: 3 years
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati