Attention Intervention Management (AIM)
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ClinicalTrials.gov Identifier: NCT01779427 |
Recruitment Status
:
Withdrawn
(Based on data from pilot study, the PI and program officer have determined that this study was not feasible.)
First Posted
: January 30, 2013
Last Update Posted
: March 8, 2016
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Condition or disease | Intervention/treatment | Phase |
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Traumatic Brain Injury (TBI) Attention Deficit Hyperactivity Disorder (ADHD) Head Injury Brain Concussion Head Injuries, Closed | Behavioral: AIM | Not Applicable |
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 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 |
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.
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Experimental: Wait List Control
Participants are in the Wait List Control group for 10 weeks and then they will participate in the AIM Intervention
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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.
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- Parent Report Measures [ Time Frame: 3 years ]
- Teacher Report Measures [ Time Frame: 3 years ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01779427
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229 |
Principal Investigator: | Shari L Wade, PhD | Cincinnati Children's Hosiptal Medical Center | |
Principal Investigator: | McKay M Sohlberg, PhD | University of Oregon |
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 Key Record Dates |
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 |