Please select the eligibility criteria that correspond to the clinical trial below.
Title: Child/Adolescent Anxiety Multimodal Treatment Study
Brief Summary: This randomized, controlled trial compared the efficacy of the medication sertraline (Zoloft®), cognitive-behavioral therapy, the combination of these treatments, and placebo for youth with anxiety disorders.


Options:
A: Inclusion Criteria:

1. Outpatient children with an autism spectrum disorder (see #2 below) between the ages 11-16 years.
2. Meets criteria for a diagnosis of autism, Asperger syndrome (AS), or PDD-NOS using scores from the Autism Diagnostic Interview-Revised and the Childhood Autism Rating Scale.
3. Meets DSM-IV criteria for a diagnosis of one of the following anxiety disorders: separation anxiety disorder (SAD), generalized anxiety disorder (GAD), social phobia, or obsessive compulsive disorder (OCD) as determined by the ADIS-IV-C/P (with CSR 4) and all available information.
4. Minimum score of 13 on the PARS Severity Scale; this score indicates clinically significant anxiety symptom severity (RUPP, 2002) and has been used in recent major clinical trials (e.g., Walkup et al., 2008).
5. Child has a Full Scale and Verbal Comprehension IQ \> 80 as assessed on a commonly used IQ test.
6. Subjects with co-morbid depression, ADHD, tic disorder or disruptive behavior disorders will be acceptable as long as the anxiety disorder is primary (i.e., most impairing/distressing).

Exclusion Criteria:

1. Receiving concurrent psychotherapy, social skills training, or behavioral interventions (e.g., applied behavior analysis). Families will have the option of discontinuing such services to enroll in the study.
2. New Treatments: Initiation of an antidepressant within 12 weeks before study enrollment or an antipsychotic 6 weeks before study enrollment. No new alternative medications, nutritionals or therapeutic diets within 6 weeks of study enrollment.
3. Established Treatment changes: Any change in established psychotropic medication (e.g., antidepressants, anxiolytics) within 8 weeks before study enrollment (6 weeks for antipsychotic). Alternative medications that might have behavioral effects must be stable for 6 weeks prior to the study baseline assessment. Any medications that the adolescent is on must remain stable during treatment. If a potential participant is taking psychotropic medication at the time of the phone evaluation or the first in-person study assessment and wishes to discontinue this medication to enter the study, the patient will be asked to discuss this option with their prescribing physician to determine whether medication discontinuation would be safe and in the adolescent's best interest. In addition, we will obtain the patient's written consent to contact their treating clinician to determine the appropriateness of study participation. We will not influence the decision patients make with their prescribing physician. All pharmacotherapy recommendations will be made in consultation with Dr. Murphy.
4. (a) Current clinically significant suicidality or (b) individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention.
5. Lifetime DSM-IV bipolar, schizophrenia or schizoaffective disorders; or Substance abuse in past 6 months.
6. Unwillingness of parents to make the commitment to accompany their child for multiple study visits.
7. Presence of a significant and/or unstable medical illness which might lead to hospitalization during the study.
B: Inclusion Criteria:

* Clinical diagnosis of DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and Social Phobia (SP)

Exclusion Criteria:

* 1. IQ below 70 as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI).

  2. Requires current ongoing treatment with psychoactive medications including anxiolytics and antidepressants.

  3. Acutely suicidal or at risk for harm to self or others. 4. Any motor impairments or eye-hand coordination problems 5. Persons not suited for fMRI procedures including those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, IUDs, metal braces, or other metal objects in their body, especially in the eye. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. Pregnancy, determined by pregnancy tests on post-menarcheal females.

  6. History of head injury. 7. Neuromuscular or neurological disorder 8. Vision that is 20/40 and below that cannot be corrected by glasses or contacts.

Specific exclusion criteria for anxious participants includes:

1. Current comorbid diagnosis of: primary major depressive disorder (MDD) (subjects who have primary GAD with co-morbid MDD that is secondary in terms of course and functional impact are not excluded), obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), conduct disorder, substance abuse or dependence
2. Lifetime diagnosis of autism or Asperger syndrome, bipolar disorder, psychotic depression, schizophrenia, or schizoaffective disorder.

Specific exclusion criteria for controls includes:

1. Any current or lifetime DSM-IV diagnosis.
2. Having a parent with current or lifetime DSM-IV diagnosis of anxiety or mood disorders.
C: Inclusion Criteria:

* Primary diagnosis of SAD
* Age 5 to 13 years
* Knowledge of German language
* Consent to randomization and psychological testing

Exclusion Criteria:

* Comorbid Pervasive Developmental Disorders
* Active psychotropic drugs
D: Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for separation anxiety disorder, social phobia, or generalized anxiety disorder

Exclusion Criteria:

* Major neurological disorder or medical illness that would interfere with participation in the study

Answer: D