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Traumatic Brain Injury | Internet-based Interacting Together Everyday, Recovery After Childhood TBI (I-InTERACT)--RRTC

Traumatic Brain Injury research study

What is the primary objective of this study?

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 is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Traumatic Brain Injury

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Internet-based Interacting Together Everyday: Recovery After Childhood TBI (I-InTERACT)Families in I-InTERACT will view 10 web-sessions (like chapters) and participate in 27 family meetings over the course of 24 weeks focusing on increasing positive parenting skills, reducing parenting stress, and improving child behavior problems. Meetings will be conducted in their home using a computer hook-up with a trained therapist.

Behavioral:Internet-based-Interacting Together Everyday, Recovery after Childhood TBI Express (I-InTERACT Express)Families in I-InTERACT Express will view 10 web-sessions (like chapters) and participate in 14 family meetings over the course of 7 weeks focusing on increasing positive parenting skills, reducing parenting stress, and improving child behavior problems. Meetings will be conducted in their home using a computer hook-up with a trained therapist.

Behavioral:Internet Resources Comparison (IRC)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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Active Comparator: Internet Resources Comparison (IRC)Participants will receive the Internet resource comparison group treatment

I-InTERACTParticipants will receive a 24 week, 27 session internet-based parenting skills program

I-InTERACT ExpressParticipants will receive an abbreviated 7 week, 14 session version of the I-InTERACT parenting skills program.

Study Status

Completed

Start Date: October 2009

Completed Date: December 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Parent Report Measures

Secondary Outcome: Neuropsychological Testing

Study sponsors, principal investigator, and references

Principal Investigator: Shari L Wade, PhD

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Collaborator: MetroHealth Medical Center

More information:https://clinicaltrials.gov/show/NCT01214694

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