School-based Treatment of Anxiety Research Study (STARS)

Study Overview
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Brief Summary
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This research is being done to compare two types of talk therapy to see which is most effective in helping school children with anxiety disorders. The investigators will compare usual care (UC) with cognitive behavioral therapy (CBT). Both therapies will be administered by the school mental health counselors to see if they help children with anxiety disorders to feel less scared or worried.

Detailed Description
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This four year study involves a blocked randomized controlled trial (RCT) comparing the effectiveness of school-based CBT to usual care (UC) for approximately 375 students ages 7-17 diagnosed with an anxiety disorder. Randomization will occur at the school level and the investigators propose to conduct the study in approximately 46 schools (23 in CBT; 23 UC). Evaluations will be conducted by study staff to measure treatment progress at the end of the 12-week treatment program, at a three month follows up, and at natural termination.

Official Title
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Modular CBT for Reducing Anxiety and Improving Educational Outcomes

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Behavioral: CBT
* Behavioral: UC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between the ages of 6-18 inclusively meet DSM-IV criteria for a primary anxiety disorder Exclusion Criteria: presence of a medical or psychiatric condition contraindicating study treatment (e.g., suicidal intent) need more immediate or alternative treatment receiving psychosocial treatment for anxiety victim of previously undisclosed child abuse and require ongoing Department of Children and Families (DCF) supervision

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT<br>Cognitive behavioral therapy | Behavioral: CBT<br> <br> * Other names: Cognitive Behavioral therapy;|
| Active Comparator: UC<br>Usual care | Behavioral: UC<br> <br> * Other names: Usual Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impressions Improvement Scale | Improvement in Clinical Anxiety Diagnosis | 12 weeks post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| School Records | Academic functioning | 12 weeks post-treatment | 
| Teacher Report Form | classroom behavior and performance | 12 weeks post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Fear, Worry, Therapy, Cognitive behavioral therapy