Internet-based Interacting Together Everyday, Recovery After Childhood TBI (I-InTERACT)--RRTC
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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 |
- Parent-Child Interaction [ Time Frame: Measured at 3 months post baseline ] [ Designated as safety issue: No ]Parents receiving I-InTERACT or I-InTERACT Express will display more positive parenting behaviors (warmth, responsiveness), and fewer negative parenting behaviors (criticism) than parents in the IRC group
- Parent-Child Interaction [ Time Frame: Measured at 6 months post-baseline ] [ Designated as safety issue: No ]Parents receiving I-InTERACT or I-InTERACT Express will display more positive parenting behaviors (warmth, responsiveness)and fewer negative parenting behaviors (criticism) than parents in the IRC group.
- Parental Psychological Distress [ Time Frame: Measured at 3 months and 6 months post baseline ] [ Designated as safety issue: No ]Families receiving I-InTERACT or I-InTERACT Express will have lower levels of parental distress and fewer child behavior problems than those in the IRC group.
- Parental Psychological Distress [ Time Frame: Measured at 6 months post baseline ] [ Designated as safety issue: No ]Families receiving I-InTERACT or I-InTERACT Express will have lower levels of parental distress and fewer child behavior problems than those in the IRC group.
- Child Adjustment and Adaptive Functioning [ Time Frame: Measured at 3 months post baseline ] [ Designated as safety issue: No ]The investigators anticipate that these 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.
- Child Adjustment and Adaptive Functioning [ Time Frame: Measured at 6 months post baseline ] [ Designated as safety issue: No ]The investigators anticipate that these 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.
| Estimated Enrollment: | 120 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2013 (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 |
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| Contact: Karen Oberjohn, MA | 513-636-6264 | karen.oberjohn@cchmc.org |
| 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 | |
| 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: | June 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital Medical Center, Cincinnati:
|
brain concussion TBI intracranial edema brain edema craniocerebral trauma head injury brain hemorrhage, traumatic subdural hematoma head injuries, closed epidural hematoma extra-axial hemorrhage |
cortical contusion 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 Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013