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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01779427
Other study ID # H133B090010--03
Secondary ID
Status Withdrawn
Phase N/A
First received December 10, 2012
Last updated March 7, 2016
Start date January 2013
Est. completion date January 2014

Study information

Verified date March 2016
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 18 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


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.

Locations

Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (3)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati U.S. Department of Education, University of Oregon

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Parent Report Measures 3 years No
Secondary Teacher Report Measures 3 years No
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