Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study (CATS)
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Purpose
The purpose of this study is to investigate neurobehavioral, affective, and social processes that may influence and predict treatment response in pediatric anxiety disorders.
| Condition | Intervention |
|---|---|
|
Generalized Anxiety Disorder Separation Anxiety Disorder Social Phobia |
Behavioral: Cognitive Behavioral Therapy Behavioral: Client Centered Therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Transdisciplinary Studies of CBT for Anxiety in Youth |
- 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. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Cognitive and affective information processing will be measured using fMRI, pupil dilation/eye tracking, and event-related potential (ERP) assessment. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1. Cognitive Behavioral Therapy |
Behavioral: Cognitive Behavioral Therapy
16 sessions of CBT
|
| Active Comparator: 2. Client Centered Therapy |
Behavioral: Client Centered Therapy
16 sessions of CCT
|
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.
Eligibility| Ages Eligible for Study: | 9 Years to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts 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 exclusion criteria for anxious participants includes:
- 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
- Lifetime diagnosis of autism or Asperger syndrome, bipolar disorder, psychotic depression, schizophrenia, or schizoaffective disorder.
Specific exclusion criteria for controls includes:
- Any current or lifetime DSM-IV diagnosis.
- Having a parent with current or lifetime DSM-IV diagnosis of anxiety or mood disorders.
Contacts and Locations| Contact: Sherri Karas, MA | 412-383-8182 | scheboths@upmc.edu |
| Contact: Laura J Trubnick, MSW | 412-383-8185 | trubnicklj@upmc.edu |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Sherri Karas | |
| Contact: Laura Trubnick | |
| Principal Investigator: Ron E Dahl, MD | |
| Sub-Investigator: Jennifer S Silk, PhD | |
| Sub-Investigator: Greg J Siegle, PhD | |
| Sub-Investigator: Erika E Forbes, PhD | |
| Sub-Investigator: Satish Iyengar, PhD | |
| Sub-Investigator: Cecile Ladouceur, PhD | |
| Sub-Investigator: Michael Schlund, PhD | |
| Principal Investigator: Neal D Ryan, MD | |
| Principal Investigator: | Neal D Ryan, MD | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | Neal Ryan, Joaquim Puig-Antich Professor of Psychiatry, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00774150 History of Changes |
| Other Study ID Numbers: | PRO07110273, P50 MH080215-01A1 |
| Study First Received: | October 16, 2008 |
| Last Updated: | October 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
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 |
Additional relevant MeSH terms:
|
Anxiety Disorders Anxiety, Separation Mental Disorders Phobic Disorders Mental Disorders Diagnosed in Childhood |
ClinicalTrials.gov processed this record on May 19, 2013