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Response Variability in Children With Attention Deficit Hyperactivity Disorder (ADHD)

This study has been completed.
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati Identifier:
First received: November 9, 2010
Last updated: April 2, 2012
Last verified: April 2012
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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Response Variability in Children With ADHD

Resource links provided by NLM:

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • 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. ]

    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
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


Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria. Participants for the study must meet all of the following criteria:

  1. Consent: The family must provide signature of informed consent by parents or legal guardians.
  2. Age at time of Screening: 7 years to 11 years, inclusive
  3. Gender: includes male and female children.
  4. 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.
  5. 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).
  6. 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.
  7. 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:

  1. Understanding Level. The patient and parent cannot understand or follow instructions given in the study.
  2. History of Psychiatric Medications: Children who have a history of taking any medication for psychological or psychiatric problems will be excluded from participation.
  3. Exclusionary Psychiatric Conditions: Children whose primary diagnosis is something other than ADHD will be excluded from participation.
  4. 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).
  5. 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
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Please refer to this study by its identifier: NCT01238822

United States, Ohio
Cincinnati Childrens Hospital
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Children's Hospital Medical Center, Cincinnati Identifier: NCT01238822     History of Changes
Other Study ID Numbers: R01MH074770 ( U.S. NIH Grant/Contract )
Study First Received: November 9, 2010
Results First Received: July 14, 2011
Last Updated: April 2, 2012

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents processed this record on September 21, 2017