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

Study Overview
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Brief Summary
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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.

Detailed Description
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The investigators will conduct a multi-site randomized controlled trial (RCT) comparing the efficacy of 7-week Internet-based Interacting Together Everyday, Recovery after Childhood Traumatic Brain Injury Express (I-InTERACT Express) and 24-week long web-based positive parenting skills programs Internet-based Interacting Together Everyday, Recovery after Childhood Traumatic Brain Injury (I-InTERACT) to an internet resource group (IRC) involving access to internet resources and education about brain injury. The project builds upon the feasibility and efficacy findings from an ongoing randomized trial comparing the efficacy of a 24-week positive parenting skills program to access to internet resources. However, it differs in size and scope by including multiple sites, and by including an abbreviated parenting skills training arm in response to family feedback that the existing 24-week intervention was excessively long, resulting in adherence difficulties. The investigators anticipate that the improvements in parenting skills and psychological functioning will translate into improved parent-child relationships and reductions in child behavior problems. Over time, such improvements in child and parent functioning should contribute to academic and social success and more successful community integration.

Official Title
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Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Internet-based Interacting Together Everyday, Recovery After Childhood TBI

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Behavioral: Internet-based Interacting Together Everyday: Recovery After Childhood TBI (I-InTERACT)
* Behavioral: Internet-based-Interacting Together Everyday, Recovery after Childhood TBI Express (I-InTERACT Express)
* Behavioral: Internet Resources Comparison (IRC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Comparator: Internet Resources Comparison (IRC)<br>Participants will receive the Internet resource comparison group treatment | Behavioral: Internet Resources Comparison (IRC)<br>* 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.<br>* Other names: IRC;|
| Experimental: I-InTERACT<br>Participants will receive a 24 week, 27 session internet-based parenting skills program | Behavioral: Internet-based Interacting Together Everyday: Recovery After Childhood TBI (I-InTERACT)<br>* 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.<br>* Other names: I-InTERACT;|
| Experimental: I-InTERACT Express<br>Participants will receive an abbreviated 7 week, 14 session version of the I-InTERACT parenting skills program. | Behavioral: Internet-based-Interacting Together Everyday, Recovery after Childhood TBI Express (I-InTERACT Express)<br>* 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.<br>* Other names: I-InTERACT Express;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent Report Measures |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological Testing |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TBI, intracranial edema, brain edema, craniocerebral trauma, head injury, brain hemorrhage, traumatic, subdural hematoma, brain concussion, head injuries, closed, epidural hematoma, extra-axial hemorrhage, cortical contusion, Additional relevant MeSH terms:, Nervous System Diseases, Wounds and Injuries, Disorders of Environmental Origin, Central Nervous System Diseases, Trauma, Nervous System, Brain Diseases, Brain Injuries