Clinical trial NCT01118650: Concordance of the Quotient Attention Deficit Hyperactivity Disorder (ADHD) System Report With Teacher and Parent Assessments for Symptoms of ADHD
Official title: Concordance of the Quotient ADHD System Report With Teacher and Parent Assessments in School-Aged Children Receiving an Individualized Education Program (IEP) or 504 Accommodations in the Classroom Setting for Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Inattention
Hyperactivity
Impulsivity
Lead sponsor: BioBehavioral Diagnostics Company
Sponsor class: INDUSTRY
Collaborators: name: New Hampshire School Administrative Unit #44
First posted: 2010-05-07
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Public School based study for children ages 8 through 14 years of age who have been identified and are currently receiving an Individualized Education Program (IEP) or 504 accommodations in the classroom setting for symptoms of Attention Deficit Hyperactivity Disorder

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: BioBehavioral Diagnostic Company
name: Calvin R Sumner, MD
role: PRINCIPAL_INVESTIGATOR
References: