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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01118650
Other study ID # BBD0108
Secondary ID
Status Withdrawn
Phase N/A
First received May 5, 2010
Last updated April 17, 2012
Start date June 2010
Est. completion date April 2012

Study information

Verified date April 2012
Source BioBehavioral Diagnostics Company
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

To demonstrate concordance between the Quotient ADHD System Report and standard DSM-IV based parent and teacher reported rating/assessment scales, currently the accepted method of symptom measurement for subjects diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).


Description:

Public school based study for children ages 8 through 14 years of age.

Children previously identified and currently receiving an Individualized Education Program (IEP) or 504 accommodations in the classroom setting for symptoms of ADHD.

Open enrollment of 30 subjects, both male and female.

One study visit in which subjects will perform/receive the following assessments/evaluations:

1. Quotient ADHD System Test

2. Vanderbilt ADHD Diagnostic Teacher Rating Scale

3. Vanderbilt ADHD Diagnostic Parent Rating Scale

The primary analytical goal is to examine the extent of agreement of the Quotient ADHD System(either individual measures or in combination) with standard measures (Vanderbilt ADHD Diagnostic Teacher Rating Scale and Vanderbilt ADHD Diagnostic Parent Rating Scale) and to compare this agreement with that seen between the standard measures.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 14 Years
Eligibility Inclusion Criteria:

- A student attending one of three public elementary schools in the New Hampshire School Administrative Unit #44.

- Age 8 through 14 years old at time of enrollment.

- Pre-identified as receiving an Individualized Education Program (IEP) or 504 accommodations for symptoms of ADHD in the school setting by the Special Education Coordinator in the school district.

- A parent/guardian of the child must be willing to participate.

Exclusion Criteria:

- No subject will be excluded from participation based on race, ethnicity, or gender. Anyone meeting inclusion criteria, who are willing to sign consent and participate, will be included in the study.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder
  • Hyperkinesis

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
BioBehavioral Diagnostics Company New Hampshire School Administrative Unit #44
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