Attention Intervention Management (AIM)
Primary Purpose
Traumatic Brain Injury (TBI), Attention Deficit Hyperactivity Disorder (ADHD), Head Injury
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AIM
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury (TBI) focused on measuring 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
Eligibility 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
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AIM Intervention
Wait List Control
Arm Description
Participants are in the Wait List Control group for 10 weeks and then they will participate in the AIM Intervention
Outcomes
Primary Outcome Measures
Parent Report Measures
Secondary Outcome Measures
Teacher Report Measures
Full Information
NCT ID
NCT01779427
First Posted
December 10, 2012
Last Updated
March 7, 2016
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
U.S. Department of Education, University of Oregon
1. Study Identification
Unique Protocol Identification Number
NCT01779427
Brief Title
Attention Intervention Management
Acronym
AIM
Official Title
Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Attention Intervention Management
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Based on data from pilot study, the PI and program officer have determined that this study was not feasible.
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
U.S. Department of Education, University of Oregon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury (TBI), Attention Deficit Hyperactivity Disorder (ADHD), Head Injury, Brain Concussion, Head Injuries, Closed
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AIM Intervention
Arm Type
Experimental
Arm Title
Wait List Control
Arm Type
Experimental
Arm Description
Participants are in the Wait List Control group for 10 weeks and then they will participate in the AIM Intervention
Intervention Type
Behavioral
Intervention Name(s)
AIM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parent Report Measures
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Teacher Report Measures
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shari L Wade, PhD
Organizational Affiliation
Cincinnati Children's Hosiptal Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
McKay M Sohlberg, PhD
Organizational Affiliation
University of Oregon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
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Attention Intervention Management
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