Attention Deficit DisorderNCT00776737
Studies of Measures of Attention
An observational study of Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2008to 14 Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Medically normal subjects, ages 6 to 60, who have a score of 25 or less on the Five Minute Hearing Test
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read the 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.
- Keywords
- Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder, Computer Aided Learning, Attention Deficits, Healthy Volunteer, HV
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study start16 Oct 2008
- Study completion14 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776737
- Sponsor's protocol ID
- 090002
- Other IDs
- 09-DC-0002
- Status last verified
- 14 Jan 2011
- First submitted
- 18 Oct 2008
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Rowland AS, Lesesne CA, Abramowitz AJ. The epidemiology of attention-deficit/hyperactivity disorder (ADHD): a public health view. Ment Retard Dev Disabil Res Rev. 2002;8(3):162-70. doi: 10.1002/mrdd.10036.
PubMed 12216060Polanczyk G, Jensen P. Epidemiologic considerations in attention deficit hyperactivity disorder: a review and update. Child Adolesc Psychiatr Clin N Am. 2008 Apr;17(2):245-60, vii. doi: 10.1016/j.chc.2007.11.006.
PubMed 18295145Polanczyk G, Rohde LA. Epidemiology of attention-deficit/hyperactivity disorder across the lifespan. Curr Opin Psychiatry. 2007 Jul;20(4):386-92. doi: 10.1097/YCO.0b013e3281568d7a.
PubMed 17551354
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of Measures of Attention
- ClinicalTrials.gov ID
- NCT00776737
- Acronym / sponsor ID
- 090002
- Keywords
- Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder, Computer Aided Learning, Attention Deficits, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)US National Institutes of Health
- Study start
- 16 Oct 2008
- Study completion
- 14 Jan 2011
- First posted
- 21 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Medically normal subjects, ages 6 to 60, who have a score of 25 or less on the Five Minute Hearing Test
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 12216060Rowland AS, Lesesne CA, Abramowitz AJ. The epidemiology of attention-deficit/hyperactivity disorder (ADHD): a public health view. Ment Retard Dev Disabil Res Rev. 2002;8(3):162-70. doi: 10.1002/mrdd.10036.
- Background: PubMed 18295145Polanczyk G, Jensen P. Epidemiologic considerations in attention deficit hyperactivity disorder: a review and update. Child Adolesc Psychiatr Clin N Am. 2008 Apr;17(2):245-60, vii. doi: 10.1016/j.chc.2007.11.006.
- Background: PubMed 17551354Polanczyk G, Rohde LA. Epidemiology of attention-deficit/hyperactivity disorder across the lifespan. Curr Opin Psychiatry. 2007 Jul;20(4):386-92. doi: 10.1097/YCO.0b013e3281568d7a.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00776737, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.