School-based Treatment of Anxiety Research Study (STARS) (STARS)
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ClinicalTrials.gov Identifier: NCT01761396 |
Recruitment Status :
Completed
First Posted : January 4, 2013
Last Update Posted : January 8, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anxiety Disorders | Behavioral: CBT Behavioral: UC | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 216 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Modular CBT for Reducing Anxiety and Improving Educational Outcomes |
Actual Study Start Date : | July 2012 |
Actual Primary Completion Date : | May 1, 2018 |
Actual Study Completion Date : | June 30, 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: CBT
Cognitive behavioral therapy
|
Behavioral: CBT
Other Name: Cognitive Behavioral therapy |
Active Comparator: UC
Usual care
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Behavioral: UC
Other Name: Usual Care |
- Clinical Global Impressions Improvement Scale [ Time Frame: 12 weeks post-treatment ]Improvement in Clinical Anxiety Diagnosis
- School Records [ Time Frame: 12 weeks post-treatment ]Academic functioning
- Teacher Report Form [ Time Frame: 12 weeks post-treatment ]classroom behavior and performance
- Screen for Child Anxiety Related Emotional Disorders [ Time Frame: 12 weeks post-treatment ]Additional measures of symptoms, mediators, and moderators
- Children's Automatic Thoughts Scale [ Time Frame: 12 weeks post-treatment ]Cognitive distortions related to anxiety
- Woodcock-Johnson Tests of Achievement [ Time Frame: 12 weeks post-treatment ]Academic achievement and working memory
- Children's Global Assessment Scale [ Time Frame: 12 weeks post-treatment ]Global Functioning
- Brief Symptom Inventory [ Time Frame: 12 weeks post-treatment ]Parental psychopathology
- The TCU Organizational Readiness to Change [ Time Frame: 12 weeks post-treatment ]Clinician's perceptions of workplace attributes

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Ages Eligible for Study: | 6 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761396
United States, Connecticut | |
University of Connecticut Health Center | |
Farmington, Connecticut, United States, 06030 |
Principal Investigator: | Golda S Ginsburg, Ph.D. | University of Connecticut |
Responsible Party: | Golda S. Ginsburg, Professor, UConn Health |
ClinicalTrials.gov Identifier: | NCT01761396 |
Other Study ID Numbers: |
NA00075767 R324A120405 ( Other Grant/Funding Number: Institute of Educational Sciences (IES) ) |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | January 8, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Will follow IES procedures for making de-identified data set available |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Anxiety Fear Worry Therapy Cognitive behavioral therapy |
Anxiety Disorders Mental Disorders |