Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Strattera and Behavior Therapy on the School and Home Functioning of Elementary School Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: Background: Multiple studies have found Atomoxetine (Strattera) to be efficacious but there is only one published study specifically designed to evaluate its efficacy in school settings. In this 7 week placebo-controlled study, Atomoxetine (ATX) at mean dose of 1.3 mg/kg, significantly reduced teacher rated ADHD symptoms (Weiss et al., 2005). However, children are typically referred for treatment because of "real life" problems in functioning, not symptoms (Pelham, Fabiano, \& Massetti, 2005). While ATX has been found to produce functional improvements at home, the Weiss study found limited results in this area at school.

Furthermore, almost no research has examined the effects of combining ATX and behavior therapy (BT). In the MTA, adding BT to stimulants improved teacher ratings of hyperactivity/impulsivity and increased the number of subjects reaching optimal response (Swanson et al., 2001). Therefore, it is possible that the addition of BT to ATX may improve functional performance in the classroom. The effects of combined therapy may be even larger for ATX as monotherapy with nonstimulants produces smaller effect sizes than with stimulants.

Objective: The primary objective was to evaluate the effects of ATX alone and in combination with BT on the school functioning of 56 children ages 6-12 with ADHD. Outcomes were assessed using traditional symptoms measures as well as functional measures of academic and behavioral improvements in the classroom.


Options:
A: Inclusion Criteria:

1. meet DSM-IV diagnostic criteria for ADHD-combined type;
2. estimated IQ of 75 or higher;
3. agree to comply with the randomly assigned treatment condition;
4. enrolled in full time school at first grade level or higher; AND
5. have a primary teacher available to complete ratings for the entire study duration.

Exclusion Criteria:

1. current or past history of seizures (not including benign febrile seizures) or other neurological disorders;
2. physical conditions that preclude administration of Strattera or other medical illness that might confound study results or increase the safety risk to subjects exposed to study treatments (i.e. marked cardiac conduction delay, etc.);
3. prior failed trial of Strattera defined as 3 weeks or more on a daily dose of Strattera of at least .8mg/kg or a documented inability to tolerate at least .8mg/kg/day;
4. serious forms of psychopathology other than ADHD, such autism, bipolar disorder, schizophrenia or any other psychopathology requiring urgent treatment with psychotropic medication; OR
5. children for whom discontinuation of their current psychotropic medication would represent a serious risk to themselves or others.

The presence of Oppositional Defiant Disorder (ODD), Conduct Disorder (CD) or learning disabilities will not result in exclusion from the study as they are commonly occurring comorbidities that have not been found to moderate response to ADHD treatments (Jensen et al., 2001). Enrollment in special education services will also not be an exclusionary criteria as work by this research group has found that such services do not affect response to ADHD treatments (Niemic, Fabiano, Pelham, \& Fuller, 2002).
B: Inclusion Criteria:

* ADHD combined subtype with evidence of depressive or manic-like symptoms, as assessed by CDRS, YMRS, and Washington University in St. Louis Kiddie Schedule for Affective Disorders and Schizophrenia, that persist after stimulant treatment

Exclusion Criteria:

* Full Scale IQ less than 80
* Current seizure disorder or history of seizures requiring treatment or other significant neurological problems
* History of other medical problems for which stimulant treatment may involve considerable risk, including cardiac arrhythmias, hypertension, Tourette's disorder, or history of severe tic exacerbations caused by stimulant exposure (Note: child with uncomplicated tic disorders or a family history of tic disorders will not be excluded as stimulants are well tolerated in a majority of such cases)
* Meets full criteria for Type I or II bipolar disorder or any child manifesting mood symptoms (manic or depressive), such as significant suicidal ideation or psychotic symptoms that require emergent pharmacological treatment or hospitalization
* History or concurrent diagnosis of any of the following disorders: pervasive developmental disorder, schizophrenia or other psychotic disorders, post-traumatic stress disorder, sexual disorders, organic mental disorder, or eating disorder
* No longer manifests impairing manic/depressive symptoms after stimulant therapy based on CDRS-R greater than 27 or YMRS greater than 11 with Clinical Global Impressions-Severity 3 or greater
C: Inclusion Criteria:

* clinical diagnosis of child ADHD
* full-scale intelligence quotient (FSIQ) ≥70
* stable on medication for ADHD children at least 3 months

Exclusion Criteria:

* individuals with major neurological disorders
* a diagnosis of schizophrenia, epilepsy, mental retardation or other brain disorders
D: Inclusion Criteria:

1. The parents should be interested in taking part in parental groups in Børnepsykiatrisk Ambulatorium in Holbæk.
2. The patients (and the parents) must understand and speak Danish language to an extent where a translator is not needed in order to be able to complete the assessment and the treatment.
3. The patients´ parents must give informed consent to participate in the trial.
4. The children must be between 8-12 years old by the time of the start of the assessment.
5. Both boys and girls can participate.
6. Children with a total verbal or nonverbal IQ\>80 according to the WISC III.
7. The children must fulfil research criteria for the diagnosis ADHD according to DSM IV (1994): 314.00, 314.01,314.02 or 314.9.
8. The parents must be prepared to the fact that their children have to receive medical treatment for their ADHD.

Exclusion Criteria:

Patients with the following diagnoses according to DSM IV:

1. Schizophrenia:

   295.30(Paranoid type) 295.10(Disorganized type) 295.20(Catatonic type) 295.90(Undifferentiated type) 295.60(Residual type) 295.70(Schizoaffective Disorder) 297.1(Delusional Disorder) 298.8(Brief Psychotic Disorder) 297.3(Shared Psychotic Disorder) 298.9(Psychotic Disorder Not Otherwise Specified)
2. Children with autism according to DSM IV:

   299.00 (Autistic Disorder) 299.10 (Childhood Disintegrative Disorder) 299.80 (Asperger´s Disorder) or a cut of score on both the SCQ questionnaires \>15.
3. Violent and criminal youngsters.
4. Children with a total verbal or nonverbal IQ\<80 according to WISC III
5. Strong resistance from the child against participating.
6. Previous started medical treatment for ADHD.

Answer: A