Attention Intervention Management (AIM)

This study has been withdrawn prior to enrollment.

(Based on data from pilot study, the PI and program officer have determined that this study was not feasible.)

Sponsor:

Collaborators:

U.S. Department of Education

University of Oregon

Information provided by (Responsible Party):

Children's Hospital Medical Center, Cincinnati

ClinicalTrials.gov Identifier:

NCT01779427

First received: December 10, 2012

Last updated: March 7, 2016

Last verified: March 2016

History of Changes

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
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

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder Concussion Head Injuries Traumatic Brain Injury

U.S. FDA Resources

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:

Parent Report Measures [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Teacher Report Measures [ Time Frame: 3 years ] [ Designated as safety issue: No ]


Enrollment:	0
Study Start Date:	January 2013
Study Completion Date:	January 2014
Primary Completion Date:	January 2014 (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.
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.

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 (Child, Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779427

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


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:	March 7, 2016
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:


Wounds and Injuries Brain Injuries 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

ClinicalTrials.gov processed this record on September 26, 2016

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