Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia
Conditions
Keywords
Neural correlates of pediatric anxiety disorder, Social correlates of pediatric anxiety disorder, Generalized Anxiety Disorder in pediatric populations, Separation Anxiety Disorder in pediatric populations, Social Phobia in pediatric populations
Brief summary
The purpose of this study is to investigate neurobehavioral, affective, and social processes that may influence and predict treatment response in pediatric anxiety disorders.
Detailed description
This protocol proposes to study neurobehavioral and social correlates of treatment response in 200 youth (ages 9-13) with general anxiety disorder (GAD), separation anxiety disorder (SAD), and social phobia (SP). All youth with an anxiety disorder will receive 14 weeks of Cognitive Behavioral Therapy (CBT) or Client Centered Therapy (CCT) for child anxiety disorders. The study combines state-of-the-art measures from affective neuroscience, ecologically valid (EMA) measures of mood and behavior in natural environments, and measures of family and social context within a developmentally framed treatment study. The study design focuses on predictors and mechanisms of treatment response. This protocol will test key features of a vigilance-avoidance model focusing on hypotheses that pretreatment neural correlates of affective reactivity will predict treatment response and early changes in emotional processing will correlate with clinical response during treatment. In addition, the protocol examines how affective experiences within the family and social context are associated with treatment response and change across treatment, and how these are associated with and interact with neurobehavioral changes in affective functioning. Taken together these aspects of the study will advance understanding of the neurobehavioral, affective, and social processes that underpin treatment response in ways that will inform the design, refinement, and optimal developmental timing of cognitive behavioral treatments, and thus, decrease the morbidity, mortality, and lifetime impairments from these common disorders in youth.
Interventions
BEHAVIORALCognitive Behavioral Therapy
16 sessions of CBT
BEHAVIORALClient Centered Therapy
16 sessions of CCT
Sponsors
National Institute of Mental Health (NIMH)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to 14 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evidence of therapy effects on anxiety symptoms are established by assessments of clinical status, symptoms, affective style, sleep,parent-child interactions using rating scales, self-report measures, and behavioral observations. | 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive and affective information processing will be measured using fMRI, pupil dilation/eye tracking, and event-related potential (ERP) assessment. | 16 weeks |
Countries
United States
Outcome results
None listed