Please select the eligibility criteria that correspond to the clinical trial below.
Title: Explanatory Clinical Trial of a Novel Parent Intervention for Childhood Anxiety (SPACE)
Brief Summary: Childhood anxiety disorders are very common, carry tremendous personal and societal costs, frequently do not respond adequately to treatment, and involving parents in treatment has so far not enhanced outcomes. Explanatory clinical trials are needed to identify parent specific mechanisms of change that are not targeted in direct child treatment, and to identify markers of who is most likely to benefit from parent intervention. This study is an explanatory clinical trial of a parent based intervention and of cognitive behavioral therapy, and an investigation of biological and behavioral moderators of treatment response.


Options:
A: 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
B: Inclusion Criteria:

Children:

* meet criteria for a primary DSM5 anxiety disorder of generalized anxiety disorder (GAD), social phobia (SOP), and separation anxiety disorder (SAD) using the DSM-5 version of the Anxiety Disorders Interview Schedule -Child and Parent Versions (ADIS-C/P)
* mean score of 4 or greater on the ADIS-C/P Clinician Rating Scale of Severity (CSR)
* ceasing all other psychosocial treatment upon consultation with the clinic staff and the service provider
* not using any psychotropic medication other than a stable dose of stimulant medication treatment for comorbid ADHD or a stable dose of Selective Serotonin Reuptake Inhibitor (SSRI)
* children who are on a stable dose of stimulant medication or SSRI (i.e., a minimum of six weeks at the same dose) will be included so as not to limit generalizability.

Exclusion Criteria:

Children:

* primary diagnosis of any Axis I DSM-IV disorder other than GAD, SOP, Phobias and SAD
* any of the following disorders (e.g., primary, secondary, tertiary) - Pervasive Developmental Disorders, Mental Retardation, Organic Mental Disorders, Bipolar Disorder, Schizophrenia and Other Psychotic Disorders
* drug or alcohol abuse/dependence will also be exclusionary
* tic disorders will not be exclusionary unless they require psychotropic medication to stabilize
* Significant active suicidal ideation or a past suicide attempt in the last 6 months. Adolescents with a history of non-lethal self-harm behaviors (e.g., cutting) will be allowed to enroll if they meet other criteria
* have an intellectual disability as reported by guardian
* be a victim of past or present undisclosed abuse requiring investigation or ongoing supervision by the Department of Social Services
* not have been cohabiting with mother for at least one year prior to admittance. Parent:
* any of the following disorders (e.g., primary, secondary, tertiary) - Pervasive Developmental Disorders, Mental Retardation, Selective Mutism, Organic Mental Disorders, Bipolar Disorder, Schizophrenia and Other Psychotic Disorders. Drug or alcohol abuse/dependence will also be exclusionary
* not have been cohabiting with child for at least one year prior to admittance
* report the presence of any active suicidal ideation or a past suicide attempt in the last 6 months.
C: 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.
D: Inclusion Criteria:

* The patient and parents agree to participate in the research project
* A primary diagnosis of specific phobia (dental anxiety or needle phobia) can be established according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition.

Exclusion Criteria:

* The diagnostic interview shows that other psychiatric or developmentally related diagnoses should be consider as the primary diagnosis
* The patient undergoing psychiatric examination and/or psychotherapy
* The patient has no dental treatment needs or the dental treatment needs are of an emergency nature.

Answer: B