Attention Intervention Management (AIM)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Traumatic Brain Injury (TBI); Attention Deficit Hyperactivity Disorder (ADHD); Head Injury; Brain Concussion; Head Injuries, Closed	Behavioral: AIM	Not Applicable

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Attention Intervention Management
Study Start Date :	January 2013
Actual Primary Completion Date :	January 2014
Actual Study Completion Date :	January 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: AIM 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.
Experimental: Wait List Control; Participants are in the Wait List Control group for 10 weeks and then they will participate in the AIM 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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Parent Report Measures [ Time Frame: 3 years ]

Secondary Outcome Measures :

1. Teacher Report Measures [ Time Frame: 3 years ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	10 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

U.S. Department of Education

University of Oregon

Investigators

Principal Investigator:	Shari L Wade, PhD	Cincinnati Children's Hosiptal Medical Center
Principal Investigator:	McKay M Sohlberg, PhD	University of Oregon

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:	NCT01779427 History of Changes
Other Study ID Numbers:	H133B090010--03
First Posted:	January 30, 2013
Last Update Posted:	March 8, 2016
Last Verified:	March 2016

Keywords provided by Children's Hospital Medical Center, Cincinnati:

traumatic brain injury (TBI); intracranial edema; brain edema; craniocerebral trauma; head injury; brain hemorrhage, traumatic; subdural hematoma; brain concussion; head injuries, closed	epidural hematoma; extra-axial hemorrhage; cortical contusion; wounds and injuries; disorders of environmental origin; trauma, nervous system; brain injuries; attention deficit hyperactivity disorder (ADHD); attention

Additional relevant MeSH terms:

Wounds and Injuries; Brain Injuries; Brain Injuries, Traumatic; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Craniocerebral Trauma; Brain Concussion; Head Injuries, Closed; Brain Diseases; Central Nervous System Diseases	Nervous System Diseases; Trauma, Nervous System; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Wounds, Nonpenetrating