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Attention Intervention Management (AIM)

Cincinnati Children's Hospital Medical Center logo

Cincinnati Children's Hospital Medical Center

Status

Withdrawn

Conditions

Head Injury
Head Injuries, Closed
Attention Deficit Hyperactivity Disorder (ADHD)
Brain Concussion
Traumatic Brain Injury (TBI)

Treatments

Behavioral: AIM

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01779427
H133B090010--03

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

10 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

AIM Intervention
Experimental group
Treatment:
Behavioral: AIM
Wait List Control
Experimental group
Description:
Participants are in the Wait List Control group for 10 weeks and then they will participate in the AIM Intervention
Treatment:
Behavioral: AIM

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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