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Studies of Measures of Attention

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ClinicalTrials.gov Identifier: NCT00776737
Recruitment Status : Completed
First Posted : October 21, 2008
Last Update Posted : July 2, 2017
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date October 18, 2008
First Posted Date October 21, 2008
Last Update Posted Date July 2, 2017
Study Start Date October 16, 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Studies of Measures of Attention
Official Title Studies of Measures of Attention
Brief Summary

This study will compare two tests for attention deficit disorder (ADD) - the Test of Variables of Attention (TOVA) and the NIH Test of Attention - to see if they produce the same results. There are a number of problems with existing tests for ADD. For example, TOVA, the most commonly used test, operates only on older computers and has other problems as well. Because of these problems, NIDCD developed the new NIH Test of Attention. This study will determine if the new test is valid for ADD and how the performance on this test compares to the performance on the TOVA in the general population.

Healthy volunteers between 6 and 60 years of age who have no problems with sight or hearing and are not taking medication for ADD may be eligible for this study.

After a brief interview, participants take the first of the two study tests. On a second visit, they take the other of the two tests. Both tests ask the subject to respond to things they hear and see on a computer screen. Each test takes 30 to 45 minutes to complete. Some participants are asked to take the NIH Test of Attention a second time, on a third visit. Participants also take a 15- to 20-minute subtest of the Weschler Intelligence Test.

Detailed Description

Characterization of a new test of attention

Objective - The objective of this protocol is to provide normative data for population performance on the NIH Test of Attention, and to compare performance on this test with subjects' performance on the traditional Test of Variables of Attention (TOVA). The NIH Test of Attention has been developed to provide a modernized test that can be made available to researchers, clinicians, and educators free of charge.

Study population - A screened medically normal population sample containing adults and children of both sexes and all ethnicities without frank mental or sensory disabilities

Design - Subjects will be enrolled by outreach designed to gather a random population sample. Subjects will take the NIH Test of Attention at one testing session and the TOVA at another session. The population distribution of scores on the NIH Test of Attention will be ascertained, the standard descriptive statistics will be calculated, and the correlation of NIH Test of Attention scores with the TOVA scores in each subject will be measured. No individual identifying information will be gathered, and no test results will be provided back to subjects.

Outcome measures - The outcome will be measured by statistical tests for significant differences from the null hypothesis, which is that there is a difference in subject performance on the TOVA compared to the NIH Test of Attention. Mean, median, variance, and standard deviation of test scores will be calculated. Score distribution and Intra-class correlations will be quantified. Correlation of scores on the NIH Test of Attention with TOVA scores will be determined using Pearson's r.

Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Attention Deficit Disorder
  • Attention Deficit Hyperactivity Disorder
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 26, 2010)
36
Original Enrollment
 (submitted: October 18, 2008)
400
Study Completion Date January 14, 2011
Primary Completion Date Not Provided
Eligibility Criteria
  • INCLUSION CRITERIA:

Medically normal subjects, ages 6 to 60, who have a score of 25 or less on the Five Minute Hearing Test

EXCLUSION CRITERIA:

Subjects currently taking medication for ADD/ADHD, those with mental disability, hearing or vision impairment to the degree that subjects would fall under the criteria of the Americans with Disabilities Act. No vulnerable subjects will be enrolled, nor will subjects with an individual or family history of epilepsy.

Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00776737
Other Study ID Numbers 090002
09-DC-0002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborators Not Provided
Investigators Not Provided
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date January 14, 2011