Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01779427
Study type Interventional
Source Children's Hospital Medical Center, Cincinnati
Contact
Status Withdrawn
Phase N/A
Start date January 2013
Completion date January 2014

See also
  Status Clinical Trial Phase
Completed NCT02299128 - Effectiveness of Early Physical Therapy Intervention for Patients With Dizziness After a Sports-Related Concussion N/A
Completed NCT02383472 - LED Therapy for the Treatment of Concussive Brain Injury N/A
Recruiting NCT06112093 - Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches N/A
Terminated NCT02597504 - Development of a Neurocognitive Screening Test N/A
Completed NCT00409058 - Teen Online Problem Solving (TOPS) - An Online Intervention Following TBI N/A
Completed NCT00295074 - The Effect of Mild Traumatic Brain Injury on Recovery From Injury N/A
Completed NCT00483444 - Telephone Follow-Up on Outcome After Mild Traumatic Brain Injury N/A
Completed NCT03319966 - Eyetracking and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury
Completed NCT04681742 - Feasibility Testing of Cognitive Strategy Training in Post-Concussive Syndrome N/A
Completed NCT03759223 - Enhanced Problem-Solving Training N/A
Completed NCT00857207 - Metacognitive Training to Enhance Strategy Use in Blast-Related TBI N/A
Not yet recruiting NCT06131242 - The s100β Levels in Patients With Mild Brain Injury.
Completed NCT02368366 - Comparative Effectiveness of Family Problem-Solving Therapy (F-PST) for Adolescent TBI N/A
Completed NCT02858544 - Concussion in Motor Vehicle Accidents: The Concussion Identification Index N/A
Completed NCT00142090 - Use of Salt-Water Solution to Improve Symptoms in Concussion N/A
Recruiting NCT05837676 - Problem-Solving Training for Concussion N/A
Recruiting NCT06015451 - Exercise in Postconcussion Symptoms and Posttraumatic Headache N/A
Completed NCT00724607 - Brain Injury Outcomes (BIO) Study
Completed NCT02486003 - Testing mTBI in Athletes N/A
Unknown status NCT02699359 - Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion N/A