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

Traumatic Brain Injury Clinical Trial

— I-InTERACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214694
• Other study ID #: H133B090010--02
• Status: Completed
• Phase: N/A
• First received: September 1, 2010
• Last updated: March 7, 2016
• Start date: October 2009
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 9 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	The Children's Hospital, Denver	Aurora	Colorado
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (5)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Children's Hospital Colorado, MetroHealth Medical Center, Nationwide Children's Hospital, Rainbow Babies and Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent Report Measures		5 years	No
Secondary	Neuropsychological Testing		5 years	No