Interacting Together Everyday: Recovery After Childhood Traumatic Brain Injury (TBI) "I-InTERACT

Not Applicable

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Behavioral: Internet Resources Comparison

• Registration Number: NCT01056146
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

The purpose of this study is to test an on-line intervention for families of young children who have experienced moderate or severe traumatic brain injury (TBI). Previous interventions were not designed to address the needs of young children with TBI, and feedback revealed a desire for more examples and materials appropriate for families of younger children. 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 group 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

Five million young children suffer from traumatic brain injury (TBI) each year resulting in new child behavior problems, parental distress, and family dysfunction. Recent studies provide evidence that online skill building interventions can reduce caregiver distress and improve child adjustment following TBI. The investigators hypothesize that the I-InTERACT group will exhibit more effective parenting skills as well as better child functioning and lower levels of parental distress at follow-up than will the IRC group. The investigators overarching goal is to reduce the risk of long-term behavioral problems and disability in young children following TBI by equipping parents with increased coping and parenting skills in a cost effective fashion. Findings will be disseminated via presentations and peer-reviewed publications, a website and newsletter, workshops with advocacy groups, and technical assistance to interested parties

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-22
• Study First Posted: 2010-01-26
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2014-09
• Last Update Submitted: 2014-10-27
• Last Update Posted: 2014-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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
• Diagnosed with moderate or severe mental retardation, autism, or a significant developmental disability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet Resources Comparison (IRC)	Internet Resources Comparison	Participants will receive the Internet resource comparison group treatment

Primary Outcome Measures

Name	Time	Method
Videotaped parent-child interactions	3 years
Parent Self Report Measures	3 years

Secondary Outcome Measures

Name	Time	Method
Neuropsychological testing	3 years

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States