Attention Intervention Management

Brain Concussion Clinical Trial

— AIM  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01779427
• Other study ID #: H133B090010--03
• Status: Withdrawn
• Phase: N/A
• First received: December 10, 2012
• Last updated: March 7, 2016
• Start date: January 2013
• Est. completion date: January 2014

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

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)
• Brain Concussion
• Brain Injuries
• Craniocerebral Trauma
• Head Injuries, Closed
• Head Injury
• Hyperkinesis
• Traumatic Brain Injury (TBI)

Intervention

Behavioral:
• AIM
An online, 12 week 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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	U.S. Department of Education, University of Oregon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent Report Measures		3 years	No
Secondary	Teacher Report Measures		3 years	No

External Links

•   Center website