School-based Treatment of Anxiety Research Study (STARS)
STARS
Modular CBT for Reducing Anxiety and Improving Educational Outcomes
2 other identifiers
interventional
216
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 12, 2012
CompletedFirst Posted
Study publicly available on registry
January 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedJanuary 8, 2019
January 1, 2019
5.8 years
October 12, 2012
January 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Global Impressions Improvement Scale
Improvement in Clinical Anxiety Diagnosis
12 weeks post-treatment
Secondary Outcomes (2)
School Records
12 weeks post-treatment
Teacher Report Form
12 weeks post-treatment
Other Outcomes (6)
Screen for Child Anxiety Related Emotional Disorders
12 weeks post-treatment
Children's Automatic Thoughts Scale
12 weeks post-treatment
Woodcock-Johnson Tests of Achievement
12 weeks post-treatment
- +3 more other outcomes
Study Arms (2)
CBT
EXPERIMENTALCognitive behavioral therapy
UC
ACTIVE COMPARATORUsual care
Interventions
Eligibility Criteria
You may qualify if:
- between the ages of 6-18 inclusively
- meet DSM-IV criteria for a primary anxiety disorder
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UConn Healthlead
- U.S. Department of Educationcollaborator
- Johns Hopkins Universitycollaborator
Study Sites (1)
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
Related Publications (1)
Ginsburg GS, Becker KD, Drazdowski TK, Tein JY. Treating Anxiety Disorders in Inner City Schools: Results from a Pilot Randomized Controlled Trial Comparing CBT and Usual Care. Child Youth Care Forum. 2012 Feb;41(1):1-19. doi: 10.1007/s10566-011-9156-4.
PMID: 22701295BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Golda S Ginsburg, Ph.D.
University of Connecticut
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 12, 2012
First Posted
January 4, 2013
Study Start
July 1, 2012
Primary Completion
May 1, 2018
Study Completion
June 30, 2018
Last Updated
January 8, 2019
Record last verified: 2019-01