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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Collaborators:
MetroHealth Medical Center
Nationwide Children's Hospital
Rainbow Babies & Children's Hospital
Children's Hospital Colorado
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01214694
First received: September 1, 2010
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Traumatic Brain Injury
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Internet-based Interacting Together Everyday, Recovery After Childhood TBI

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Parent Report Measures [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neuropsychological Testing [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2009
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Comparator: Internet Resources Comparison (IRC)
Participants will receive the Internet resource comparison group treatment
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.
Other Name: IRC
Experimental: I-InTERACT
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)
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.
Other Name: I-InTERACT
Experimental: I-InTERACT Express
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)
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.
Other Name: I-InTERACT Express

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.

  Eligibility

Ages Eligible for Study:   3 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214694

Contacts
Contact: Karen Oberjohn, MA 513-636-6264 karen.oberjohn@cchmc.org

Locations
United States, Colorado
The Children's Hospital, Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Robert Z. Blaha, MA    720-777-5896    robert.blaha@childrenscolorado.org   
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Karen Oberjohn, MA    513-636-6264    karen.oberjohn@cchmc.org   
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Britt Nielsen, PsyD    216-778-3734    bnielsen@metrohealth.org   
Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Elizabeth Roth, PhD    216-368-5783    elizabeth.roth@case.edu   
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: April Utt, MA    614-355-3471    april.utt@nationwidechildrens.org   
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
MetroHealth Medical Center
Nationwide Children's Hospital
Rainbow Babies & Children's Hospital
Children's Hospital Colorado
Investigators
Principal Investigator: Shari L Wade, PhD Children's Hospital Medical Center, Cincinnati
Principal Investigator: H. Gerry Taylor, PhD Rainbow Babies & Children's Hospital
Principal Investigator: Keith O. Yeates, PhD Nationwide Children's Hospital
Principal Investigator: Michael Kirkwood, PhD Children's Hospital Colorado
Principal Investigator: Terry Stancin, PhD MetroHealth Medical Center
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01214694     History of Changes
Other Study ID Numbers: H133B090010--02
Study First Received: September 1, 2010
Last Updated: October 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
cortical contusion
TBI
intracranial edema
brain edema
craniocerebral trauma
head injury
brain hemorrhage, traumatic
subdural hematoma
brain concussion
head injuries, closed
epidural hematoma
extra-axial hemorrhage
Additional relevant MeSH terms:
Craniocerebral Trauma
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 18, 2014