Back to resultsSchool-based Treatment of Anxiety Research Study (STARS) (STARS)
Primary Purpose
Anxiety Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT
UC
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders focused on measuring Anxiety, Fear, Worry, Therapy, Cognitive behavioral therapy
Eligibility 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 treatment for anxiety
- victim of previously undisclosed child abuse and require ongoing Department of Children and Families (DCF) supervision
Sites / Locations
- University of Connecticut Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CBT
UC
Arm Description
Cognitive behavioral therapy
Usual care
Outcomes
Primary Outcome Measures
Clinical Global Impressions Improvement Scale
Improvement in Clinical Anxiety Diagnosis
Secondary Outcome Measures
School Records
Academic functioning
Teacher Report Form
classroom behavior and performance
Full Information
NCT ID
NCT01761396
First Posted
October 12, 2012
Last Updated
January 7, 2019
Sponsor
UConn Health
Collaborators
U.S. Department of Education, Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT01761396
Brief Title
School-based Treatment of Anxiety Research Study (STARS)
Acronym
STARS
Official Title
Modular CBT for Reducing Anxiety and Improving Educational Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
U.S. Department of Education, Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Anxiety, Fear, Worry, Therapy, Cognitive behavioral therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT
Arm Type
Experimental
Arm Description
Cognitive behavioral therapy
Arm Title
UC
Arm Type
Active Comparator
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
CBT
Other Intervention Name(s)
Cognitive Behavioral therapy
Intervention Type
Behavioral
Intervention Name(s)
UC
Other Intervention Name(s)
Usual Care
Primary Outcome Measure Information:
Title
Clinical Global Impressions Improvement Scale
Description
Improvement in Clinical Anxiety Diagnosis
Time Frame
12 weeks post-treatment
Secondary Outcome Measure Information:
Title
School Records
Description
Academic functioning
Time Frame
12 weeks post-treatment
Title
Teacher Report Form
Description
classroom behavior and performance
Time Frame
12 weeks post-treatment
Other Pre-specified Outcome Measures:
Title
Screen for Child Anxiety Related Emotional Disorders
Description
Additional measures of symptoms, mediators, and moderators
Time Frame
12 weeks post-treatment
Title
Children's Automatic Thoughts Scale
Description
Cognitive distortions related to anxiety
Time Frame
12 weeks post-treatment
Title
Woodcock-Johnson Tests of Achievement
Description
Academic achievement and working memory
Time Frame
12 weeks post-treatment
Title
Children's Global Assessment Scale
Description
Global Functioning
Time Frame
12 weeks post-treatment
Title
Brief Symptom Inventory
Description
Parental psychopathology
Time Frame
12 weeks post-treatment
Title
The TCU Organizational Readiness to Change
Description
Clinician's perceptions of workplace attributes
Time Frame
12 weeks post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 treatment for anxiety
victim of previously undisclosed child abuse and require ongoing Department of Children and Families (DCF) supervision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Golda S Ginsburg, Ph.D.
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Will follow IES procedures for making de-identified data set available
Citations:
PubMed Identifier
22701295
Citation
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.
Results Reference
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School-based Treatment of Anxiety Research Study (STARS)
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