Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multimodal Treatment Study of Children With ADHD
Brief Summary: This trial is a continuation of the Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder (MTA Study). Continuation Aim 1 is to track the persistence of intervention-related effects as the MTA sample matures into mid-adolescence, including subsequent mental-health and school-related service utilization patterns as a function of MTA treatment experience (treatment assignment) and outcome (degree of treatment success at 14 mo.). Aim 2 is to test specific hypotheses about predictors, mediators, and moderators of long-term outcome among children with ADHD (e.g., comorbidity; family functioning; cognitive skills; peer relations) that may influence adolescent functioning (either independent of or through initial treatment assignment and/or 14-month treatment outcomes); and to compare how these predictors, mediators, and moderators are similar or dissimilar within the normal comparison group. Aim 3 is to track the patterns of risk and protective factors (including their mediation or moderation by initial treatment assignment and/or outcome) involved in early and subsequent stages of developing substance-related disorders and antisocial behavior. Aim 4 is to examine the effect of initial treatment assignment and degree of treatment success on later academic performance, achievement, school conduct, tendency to drop out, and other adverse school outcomes.

In the original MTA design, patients were randomly assigned to 1 of 4 treatment conditions: (1) medication only; (2) psychosocial only; (3) combined (medication and psychosocial); or (4) Assessment-and-Referral condition. All but the latter were treated intensively for 14 months, with assessments for all subjects at baseline, 3, 9, 14, and 24 months. The original MTA design thus provides short-term (10 months post-treatment) follow-up at 24 months. This continuation extends the follow-up to assessments at 36, 60, and 84 months after treatment.

A child may be eligible for this study if he/she:

Is 7 - 9 years old, and has Attention Deficit Hyperactivity Disorder (ADHD).


Options:
A: Inclusion Criteria:

-

Patients must have:

Rigorously diagnosed Attention Deficit Hyperactivity Disorder (ADHD).
B: Inclusion Criteria:

* Subjects have primary diagnosis of ADHD
* Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test
* Subject has an IQ score of \>_ 80
* Subject is able to complete as least the Basic Test of the PERMP assessment

Exclusion Criteria:

* Subject has a comorbid psychiatric diagnosis such as Axis II disorders or severe Axis I disorders
* Subject is taking Strattera(r)
* Subject has a recent history of suspected substance abuse or dependence disorder
C: Inclusion Criteria:

* DSM-IV diagnosis of ADHD, any subtype
* DSM-IV diagnosis of a disruptive behavior disorder, including CD or ODD
* Evidence of serious physical aggression, as rated on the Overt Aggression Scale-Modified, and as determined by parent or guardian ratings on the NCBRF D-Total Score. In addition, the blinded clinician must assign a clinical global impressions severity score of 4 or greater for aggression.
* Prior to random assignment, participants must be free of all psychotropic medicines for 2 weeks for most drugs (such as most antidepressants, alpha agonists, beta blockers, anxiolytics, mood stabilizers, and antihistamines), and 4 weeks for depot antipsychotics and fluoxetine.

Exclusion Criteria:

* Full-scale IQ below 71
* Pregnancy or a history of seizure disorder or other neurological or medical disorders for which medication may present a considerable risk
* Abnormal liver function
* Pervasive developmental disorder, schizophrenia or other psychotic disorders, or eating disorders
* Currently taking other psychotropic medications from which discontinuation would present a significant risk. Participants may not discontinue a satisfactory medication to participate.
* Presence or history of major depressive disorder
* Diagnosis of bipolar disorder
* A hypomanic/biphasic score of 36 or greater as rated by child's parent on the General Behavior Inventory and confirmed by clinician as indication of mood disorder
* Active substance abuse disorder or lack of control of substance use that does not allow for safe medication administration
* Evidence of current child abuse or neglect
* History of suicide attempt in the past year or current suicidal ideation with plan and/or intent
* Family history of type II diabetes in two or more first degree relatives, defined as biological parents and/or full biological siblings
D: Inclusion Criteria:

* Males and females ages 6 up to 18
* ADHD diagnosis with ADHD Rating Scale - 4th Edition scores ≥ 90th percentile
* In need of treatment for ADHD and able to have 2-day washout from previous medication
* Females of child-bearing potential not pregnant and practice birth control
* Subject and parent/guardian willing to comply with protocol
* Signed consent and assent

Exclusion Criteria:

* Estimated Full Scale intellectual level below 80 using Wechsler Abbreviated Scale of Intelligence (WASI)
* Current primary psychiatric diagnosis of other listed disorders
* Chronic medical illnesses: seizure, hypertension, thyroid disease, cardiac, family history of sudden death, glaucoma
* Use of psychotropic central nervous system (CNS) meds having effect exceeding 14 days from screening
* Planned use of prohibited drugs
* Is pregnant or breast-feeding
* Significant ECG or laboratory abnormalities
* Experimental drug or medical device within 30 days prior to screening
* Hypersensitivity to methylphenidate
* Inability or unwillingness to comply with protocol
* Well controlled on current ADHD treatment
* Inability to take oral capsules

Answer: A