Response Variability in Children With Attention Deficit Hyperactivity Disorder (ADHD)
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Purpose
Children with Attention Deficit Hyperactivity Disorder (ADHD) have numerous areas of neuropsychological dysfunction including response inhibition, working memory, and attention. One neuropsychological outcome measure that consistently reveals between-group differences is response variability. However, until recently, differences in response variability have been reported as an ancillary finding or viewed as a nuisance in the analyses. The specific aims of the present study are to 1) Examine response variability in ADHD patients across neuropsychological tasks to understand the breadth of this specific deficit and to understand the relation between response variability and other neuropsychological outcome measures; 2) Assess whether response variability deficits are specific to either or both of the two most prevalent ADHD subtypes (i.e., Combined Type [CT] and Predominantly Inattentive Type [PIT]); 3) Determine whether response variability in ADHD patients is affected by either medication or a variety of environmental manipulations (e.g., reward); and 4) Understand the relationship between neuropsychological measures of response variability and naturalistic instances of variable performance. Forty-five children (aged 7-11) with ADHD-CT, 45 children with ADHD-PIT, and 45 normal controls will be recruited to examine response variability across a wide range of neuropsychological tests. Task parameters such as event rate, stimulus saliency, and the presence of operant reward will be modified on each test to determine the conditions under which response variability is manifested in children with ADHD. In addition, all children with ADHD will participate in a placebo-controlled, randomized medication trial with a psychostimulant medication to assess the effects of medication on response variability. Advanced analytic methods utilizing non-Gaussian distributions and fast Fourier Transforms of the reaction time data will be used to conduct detailed analyses of RT patterns across the ADHD and normal control groups. Further, the effects of task parametric manipulations and medication on response variability will be examined. Finally, relations between response variability on neuropsychological tests and response variability in a variety of real-world analog situations will be examined to evaluate the ecological validity of these deficits.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder |
Drug: Methylphenidate Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | Response Variability in Children With ADHD |
- Attention Deficit / Hyperactivity Disorder Total Sum Score of All 18 ADHD Symptom Items [ Time Frame: end of first week, end of second week, end of third week, end of fourth week. Total of 4 weeks. ] [ Designated as safety issue: No ]
Parent and teacher Vanderbilt ADHD Rating Scales - Attention Deficit / Hyperactivity Disorder Total sum score of all 18 ADHD symptom items - range equals 0-54
O - No ADHD symptoms 54 - Highest ADHD symptoms
| Enrollment: | 96 |
| Study Start Date: | June 2006 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: placebo
Placebo
|
|
Active Comparator: Low Dose Methylphenidate
Low dose: 18 mg methylphenidate
|
Drug: Methylphenidate
18 mg methylphenidate
Other Name: Concerta
|
|
Active Comparator: Medium Dose Methylphenidate
Medium Dosage: 36 mg if more than 50 kg and 27 mg if less than 50 kg
|
Drug: Methylphenidate
36 mg methylphenidate
Other Name: Concerta
|
|
Active Comparator: High Dose Methylphenidate
54 mg if more than 50 kg and 36 mg if less than 50 kg
|
Drug: Methylphenidate
54 mg methylphenidate
Other Name: Concerta
|
Eligibility| Ages Eligible for Study: | 7 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
More Information
No publications provided by Children's Hospital Medical Center, Cincinnati
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT01238822 History of Changes |
| Other Study ID Numbers: | R01MH074770 |
| Study First Received: | November 9, 2010 |
| Results First Received: | July 14, 2011 |
| Last Updated: | April 2, 2012 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Methylphenidate |
Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013