Clinical trial NCT01779427: Attention Intervention Management
Official title: Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Attention Intervention Management
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: 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
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
name: University of Oregon
First posted: 2013-01-30
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Parent Report Measures
timeFrame: 3 years
Secondary outcomes:
measure: Teacher Report Measures
timeFrame: 3 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Children's Hosiptal Medical Center
name: Shari L Wade, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oregon
name: McKay M Sohlberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: