Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-27 @ 12:53 AM
Study NCT ID:
NCT01118650
Status:
WITHDRAWN
Last Update Posted:
2012-04-18
First Post:
2010-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concordance of the Quotient Attention Deficit Hyperactivity Disorder (ADHD) System Report With Teacher and Parent Assessments for Symptoms of ADHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D013035', 'term': 'Spasm'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No interest from school district', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-17', 'studyFirstSubmitDate': '2010-05-05', 'studyFirstSubmitQcDate': '2010-05-06', 'lastUpdatePostDateStruct': {'date': '2012-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inattention', 'Hyperactivity', 'Impulsivity'], 'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': 'Public school based study for children ages 8 through 14 years of age.\n\nChildren previously identified and currently receiving an Individualized Education Program (IEP) or 504 accommodations in the classroom setting for symptoms of ADHD.\n\nOpen enrollment of 30 subjects, both male and female.\n\nOne study visit in which subjects will perform/receive the following assessments/evaluations:\n\n1. Quotient ADHD System Test\n2. Vanderbilt ADHD Diagnostic Teacher Rating Scale\n3. Vanderbilt ADHD Diagnostic Parent Rating Scale\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A student attending one of three public elementary schools in the New Hampshire School Administrative Unit #44.\n* Age 8 through 14 years old at time of enrollment.\n* 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.\n* A parent/guardian of the child must be willing to participate.\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT01118650', 'briefTitle': 'Concordance of the Quotient Attention Deficit Hyperactivity Disorder (ADHD) System Report With Teacher and Parent Assessments for Symptoms of ADHD', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioBehavioral Diagnostics Company'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'BBD0108'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Calvin R Sumner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BioBehavioral Diagnostic Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioBehavioral Diagnostics Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'New Hampshire School Administrative Unit #44', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}