Attention Intervention Management (AIM)
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Purpose
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 | Intervention |
|---|---|
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Traumatic Brain Injury (TBI) Attention Deficit Hyperactivity Disorder (ADHD) Head Injury Brain Concussion Head Injuries, Closed |
Behavioral: AIM |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Attention Intervention Management |
- Parent Report Measures [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Teacher Report Measures [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 5 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
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.
Eligibility| Ages Eligible for Study: | 10 Years to 18 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01779427
| Contact: Jessica King, BS | 513-636-9631 | jessica.king1@cchmc.org |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: Jessica King, BS 513-636-9631 jessica.king1@cchmc.org | |
| Principal Investigator: Shari L Wade, PhD | |
| Principal Investigator: | Shari L Wade, PhD | Cincinnati Children's Hosiptal Medical Center | |
| Principal Investigator: | McKay M Sohlberg, PhD | University of Oregon |
More Information
Additional Information:
No publications provided
| Responsible Party: | Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT01779427 History of Changes |
| Other Study ID Numbers: | H133B090010--03 |
| Study First Received: | December 10, 2012 |
| Last Updated: | October 27, 2014 |
| Health Authority: | United States: Institutional Review Board |
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:
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Attention Deficit Disorder with Hyperactivity Brain Concussion Brain Injuries Craniocerebral Trauma Head Injuries, Closed Attention Deficit and Disruptive Behavior Disorders Brain Diseases |
Central Nervous System Diseases Mental Disorders Mental Disorders Diagnosed in Childhood Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating |
ClinicalTrials.gov processed this record on February 27, 2015