Status:
COMPLETED
Response Variability in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
7-11 years
Phase:
PHASE4
Brief Summary
Children with Attention Deficit Hyperactivity Disorder (ADHD) have numerous areas of neuropsychological dysfunction including response inhibition, working memory, and attention. One neuropsychological...
Eligibility Criteria
Inclusion
- Inclusion Criteria. Participants for the study must meet all of the following criteria:
- Consent: The family must provide signature of informed consent by parents or legal guardians.
- Age at time of Screening: 7 years to 11 years, inclusive
- Gender: includes male and female children.
- ADHD Diagnostic Status: ADHD patients must meet DSM-IV criteria for ADHD, Inattentive or Combined subtype. Normal controls must not meet DSM-IV criteria for ADHD, any subtype. Section D.4 below describes in detail the diagnostic process for arriving at diagnosis.
- Cognitive Functioning: IQ of greater than 80 as estimated by Vocabulary and Block Design subtests of the Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV).
- Learning Disability: All children will be administered the abbreviated WIAT including the Spelling, Reading, and Math subtests. Children must score above 80 on all three WIAT subtests.
- School: Children must be enrolled in a school setting from which teacher ratings can be obtained.
- Exclusion Criteria. Potential participants will be excluded if they meet any of the following criteria:
- Understanding Level. The patient and parent cannot understand or follow instructions given in the study.
- History of Psychiatric Medications: Children who have a history of taking any medication for psychological or psychiatric problems will be excluded from participation.
- Exclusionary Psychiatric Conditions: Children whose primary diagnosis is something other than ADHD will be excluded from participation.
- Developmental Disabilities. As a result of scores on the IQ screening, additional assessments, or the judgment of the study clinicians, patients will be excluded if they are deemed to be significantly developmentally delayed. This includes clinically significant delays in cognitive function or the presence of other Pervasive Developmental Disorders (PDD).
- Organic Brain Injury: Children must not have a history of head trauma, neurological disorder, or any other organic disorder that could possibly affect brain function.
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01238822
Start Date
June 1 2006
End Date
June 1 2009
Last Update
April 4 2012
Active Locations (1)
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1
Cincinnati Childrens Hospital
Cincinnati, Ohio, United States, 45229