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School-based Treatment of Anxiety Research Study (STARS) (STARS)
This study is ongoing, but not recruiting participants.
Sponsor:
UConn Health
Collaborators:
U.S. Department of Education
Johns Hopkins University
Information provided by (Responsible Party):
Golda S. Ginsburg, UConn Health
ClinicalTrials.gov Identifier:
NCT01761396
First received: October 12, 2012
Last updated: March 23, 2017
Last verified: February 2015
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Purpose
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.
| Condition | Intervention |
|---|---|
| Anxiety Disorders | Behavioral: CBT Behavioral: UC |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Outcomes Assessor Primary Purpose: Treatment |
| Official Title: | Modular CBT for Reducing Anxiety and Improving Educational Outcomes |
Resource links provided by NLM:
Further study details as provided by Golda S. Ginsburg, UConn Health:
Primary Outcome Measures:
- Anxiety Disorders Interview Schedule for DSM-IV, Parent and Child Versions [ Time Frame: 12 weeks post-treatment ]Anxiety diagnosis
Secondary Outcome Measures:
- School Records [ Time Frame: 12 weeks post-treatment ]Academic functioning
- Teacher Report Form [ Time Frame: 12 weeks post-treatment ]classroom behavior and performance
Other Outcome Measures:
- 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
- Urban Hassles Index [ Time Frame: 12 weeks post-treatment ]Exposure to community crime and violence
- 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
| Enrollment: | 216 |
| Actual Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | August 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CBT
Cognitive behavioral therapy
|
Behavioral: CBT
Other Name: Cognitive Behavioral therapy
|
|
Active Comparator: UC
Usual care
|
Behavioral: UC
Other Name: Usual Care
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 or pharmacological treatment for anxiety
- victim of previously undisclosed child abuse and require ongoing Department of Children and Families (DCF) supervision
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761396
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761396
Locations
| United States, Connecticut | |
| University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06030 | |
Sponsors and Collaborators
UConn Health
U.S. Department of Education
Johns Hopkins University
Investigators
| Principal Investigator: | Golda S Ginsburg, Ph.D. | University of Connecticut |
More Information
Publications:
| Responsible Party: | Golda S. Ginsburg, Professor, UConn Health |
| ClinicalTrials.gov Identifier: | NCT01761396 History of Changes |
| Other Study ID Numbers: |
NA00075767 R324A120405 ( Other Grant/Funding Number: Institute of Educational Sciences (IES) ) |
| Study First Received: | October 12, 2012 |
| Last Updated: | March 23, 2017 |
Keywords provided by Golda S. Ginsburg, UConn Health:
|
Anxiety Fear Worry Therapy Cognitive behavioral therapy |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 26, 2017