Interacting Together Everyday: Recovery After Childhood Traumatic Brain

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01056146
Study type	Interventional
Source	Children's Hospital Medical Center, Cincinnati
Contact
Status	Completed
Phase	N/A
Start date	June 2008
Completion date	December 2011

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms