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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Children's Hospital Medical Center, Cincinnati

Current Primary Outcome: Parent Report Measures [ Time Frame: 5 years ]

Original Primary Outcome:

• Parent-Child Interaction [ Time Frame: Measured at 3 months post baseline ]
  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 ]
  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.

Current Secondary Outcome: Neuropsychological Testing [ Time Frame: 5 years ]

Original Secondary Outcome:

• Parental Psychological Distress [ Time Frame: Measured at 3 months and 6 months post baseline ]
  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 ]
  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 ]
  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 ]
  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.

Information By: Children's Hospital Medical Center, Cincinnati

Dates:
Date Received: September 1, 2010
Date Started: October 2009
Date Completion:
Last Updated: March 7, 2016
Last Verified: March 2016