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Clinical Trials/NCT01779427
NCT01779427
Withdrawn
Not Applicable

Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Attention Intervention Management

Children's Hospital Medical Center, Cincinnati1 site in 1 countryJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury (TBI)
Sponsor
Children's Hospital Medical Center, Cincinnati
Locations
1
Primary Endpoint
Parent Report Measures
Status
Withdrawn
Last Updated
10 years ago

Overview

Brief Summary

This is a research study to learn if a computer-based intervention that provides direct attention and metacognitive strategy development can improve attention, memory, and executive control in adolescents with moderate-to-severe TBI who are experiencing attention difficulties post injury.

Detailed Description

Impairments in attention are among the symptoms most frequently reported by parents and teachers following pediatric traumatic brain injury (TBI_. These cognitive disabilities are responsible for a wide range of academic and adjustment issues. Broadly defined, attention encompasses all of the mental processes, operations, and systems requisite for acquiring and applying information. It interacts with other cognitive functions including perception, memory/learning, organization, and reasoning; attention is core to the integration of those systems. A number of different attentional subcomponents with interconnected neural systems have been identified and shown to be differentially disrupted following trauma and other brain disorders, including maintenance or sustained attention, attentional selectivity, attentional capacity, and ability to effectively shift attention. Given the prevalence of attention difficulties and secondary attention deficit hyperactivity disorder (ADHD) following TBI, it is imperative to identify treatments to effectively address attention impairments. The study will develop and pilot the Attention Intervention and Management program (AIM). AIM focuses on direct attention training in conjunction with metacognitive strategy training. Strategies are designed to improve focus and self regulation, reduce distractions, and enhance problem solving in academic settings. Integration of attention training and metacognitive strategies will help to ensure that the student can apply the skills across settings and situations. The Randomized Controlled Trial (RCT) in Phase 2 of this project will address two interrelated hypotheses: Hypothesis 1: Children receiving the Attention Intervention and Management (AIM) program will evidence better performance on standardized tests of attention and executive functions (EF) than those in the wait list control (WLC) group. Hypothesis 2: Children receiving AIM will have fewer attention and EF problems than those in the WLC on parent and teacher rating scales of attention and EF. Participants will include children ages 10-18 with significant evidence of attentional impairments.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
January 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ages 10-18
  • significant evidence of attentional impairments
  • moderate to severe TBI
  • time since injury at least 6 months
  • completion of inpatient rehabilitation (if needed
  • English as the primary spoken language in the home.

Exclusion Criteria

  • Child does not live with parents or guardian
  • Child or parent has history of hospitalization for psychiatric problem
  • TBI is a result of child abuse
  • 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

Outcomes

Primary Outcomes

Parent Report Measures

Time Frame: 3 years

Secondary Outcomes

  • Teacher Report Measures(3 years)

Study Sites (1)

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