Trial record 8 of 11 for:    Open Studies | "Contusions"

Attention Intervention Management (AIM)

This study is currently recruiting participants.
Verified January 2014 by Children's Hospital Medical Center, Cincinnati
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: January 13, 2014
Last verified: January 2014
  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:


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 ]

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

Contacts
Contact: Holly MacPherson 513-636-2981 holly.macpherson@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Holly MacPherson    513-636-2981    holly.macpherson@cchmc.org   
Principal Investigator: Shari L Wade, PhD         
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

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: January 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
cortical contusion
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
wounds and injuries
disorders of environmental origin
trauma, nervous system
brain injuries
attention deficit hyperactivity disorder (ADHD)
attention

Additional relevant MeSH terms:
Brain Concussion
Craniocerebral Trauma
Attention Deficit Disorder with Hyperactivity
Head Injuries, Closed
Brain Injuries
Hyperkinesis
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds, Nonpenetrating
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014