Attention Deficit Hyperactivity DisorderNCT01118650
Concordance of the Quotient Attention Deficit Hyperactivity Disorder (ADHD) System Report With Teacher and Parent Assessments for Symptoms of ADHD
An observational study of Attention Deficit Hyperactivity Disorder, run by BioBehavioral Diagnostics Company.
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). Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Apr 2012
- 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 8 to 14 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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)
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).
Read the 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:
- Quotient ADHD System Test
- Vanderbilt ADHD Diagnostic Teacher Rating Scale
- 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Inattention, Hyperactivity, Impulsivity
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Spasm, Impulsive Behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: No interest from school district
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioBehavioral Diagnostics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- New Hampshire School Administrative Unit #44
- Responsible party
- Sponsor
- Investigators
- Calvin R Sumner, MD, Principal investigator, BioBehavioral Diagnostic Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118650
- Sponsor's protocol ID
- BBD0108
- Status last verified
- Apr 2012
- First submitted
- 5 May 2010
- Last updated
- 18 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01118650
- Acronym / sponsor ID
- BBD0108
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Inattention, Hyperactivity, Impulsivity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No interest from school district
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BioBehavioral Diagnostics CompanyIndustry (pharma, biotech, devices)
- Collaborators
- New Hampshire School Administrative Unit #44
- Study start
- Jun 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 7 May 2010 (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.
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:
- Quotient ADHD System Test
- Vanderbilt ADHD Diagnostic Teacher Rating Scale
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2012.
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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.
Calvin R Sumner, MD principal investigator
BioBehavioral Diagnostic Company
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder, run by BioBehavioral Diagnostics Company.
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 4 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: withdrawn, as of the sponsor's last update on 18 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
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 18 Apr 2012.