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

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet-based Interacting Together Everyday: Recovery After Childhood TBI (I-InTERACT)
Internet-based-Interacting Together Everyday, Recovery after Childhood TBI Express (I-InTERACT Express)
Internet Resources Comparison (IRC)
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring 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

Eligibility Criteria

3 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Children's Hospital, Denver
  • Cincinnati Children's Hospital Medical Center
  • Rainbow Babies and Children's Hospital
  • MetroHealth Medical Center
  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Active Comparator: Internet Resources Comparison (IRC)

I-InTERACT

I-InTERACT Express

Arm Description

Participants will receive the Internet resource comparison group treatment

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

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

Outcomes

Primary Outcome Measures

Parent Report Measures

Secondary Outcome Measures

Neuropsychological Testing

Full Information

First Posted
September 1, 2010
Last Updated
March 7, 2016
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
MetroHealth Medical Center, Nationwide Children's Hospital, Rainbow Babies and Children's Hospital, Children's Hospital Colorado
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1. Study Identification

Unique Protocol Identification Number
NCT01214694
Brief Title
Internet-based Interacting Together Everyday, Recovery After Childhood TBI (I-InTERACT)--RRTC
Acronym
I-InTERACT
Official Title
Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Internet-based Interacting Together Everyday, Recovery After Childhood TBI
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
MetroHealth Medical Center, Nationwide Children's Hospital, Rainbow Babies and Children's Hospital, Children's Hospital Colorado

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator: Internet Resources Comparison (IRC)
Arm Type
Experimental
Arm Description
Participants will receive the Internet resource comparison group treatment
Arm Title
I-InTERACT
Arm Type
Experimental
Arm Description
Participants will receive a 24 week, 27 session internet-based parenting skills program
Arm Title
I-InTERACT Express
Arm Type
Experimental
Arm Description
Participants will receive an abbreviated 7 week, 14 session version of the I-InTERACT parenting skills program.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based Interacting Together Everyday: Recovery After Childhood TBI (I-InTERACT)
Other Intervention Name(s)
I-InTERACT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based-Interacting Together Everyday, Recovery after Childhood TBI Express (I-InTERACT Express)
Other Intervention Name(s)
I-InTERACT Express
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet Resources Comparison (IRC)
Other Intervention Name(s)
IRC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parent Report Measures
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Neuropsychological Testing
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shari L Wade, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
H. Gerry Taylor, PhD
Organizational Affiliation
Rainbow Babies and Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keith O. Yeates, PhD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Kirkwood, PhD
Organizational Affiliation
Children's Hospital Colorado
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Terry Stancin, PhD
Organizational Affiliation
MetroHealth Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital, Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30499926
Citation
Aguilar JM, Cassedy AE, Shultz EL, Kirkwood MW, Stancin T, Yeates KO, Taylor HG, Wade SL. A Comparison of 2 Online Parent Skills Training Interventions for Early Childhood Brain Injury: Improvements in Internalizing and Executive Function Behaviors. J Head Trauma Rehabil. 2019 Mar/Apr;34(2):65-76. doi: 10.1097/HTR.0000000000000443.
Results Reference
derived
PubMed Identifier
29096775
Citation
Wade SL, Cassedy AE, Shultz EL, Zang H, Zhang N, Kirkwood MW, Stancin T, Yeates KO, Taylor HG. Randomized Clinical Trial of Online Parent Training for Behavior Problems After Early Brain Injury. J Am Acad Child Adolesc Psychiatry. 2017 Nov;56(11):930-939.e2. doi: 10.1016/j.jaac.2017.09.413. Epub 2017 Sep 14.
Results Reference
derived

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

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