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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
Sponsor:
Collaborators:
U.S. Department of Education
Johns Hopkins University
Information provided by (Responsible Party):
Golda S. Ginsburg, UConn Health

Tracking Information
First Submitted Date  ICMJE October 12, 2012
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date January 8, 2019
Actual Study Start Date  ICMJE July 2012
Actual Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2018)
Clinical Global Impressions Improvement Scale [ Time Frame: 12 weeks post-treatment ]
Improvement in Clinical Anxiety Diagnosis
Original Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
Anxiety Disorders Interview Schedule for DSM-IV, Parent and Child Versions [ Time Frame: 12 weeks post-treatment ]
Anxiety diagnosis
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
  • School Records [ Time Frame: 12 weeks post-treatment ]
    Academic functioning
  • Teacher Report Form [ Time Frame: 12 weeks post-treatment ]
    classroom behavior and performance
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 23, 2018)
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: January 3, 2013)
  • 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
 
Descriptive Information
Brief Title  ICMJE School-based Treatment of Anxiety Research Study (STARS)
Official Title  ICMJE Modular CBT for Reducing Anxiety and Improving Educational Outcomes
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anxiety Disorders
Intervention  ICMJE
  • Behavioral: CBT
    Other Name: Cognitive Behavioral therapy
  • Behavioral: UC
    Other Name: Usual Care
Study Arms  ICMJE
  • Experimental: CBT
    Cognitive behavioral therapy
    Intervention: Behavioral: CBT
  • Active Comparator: UC
    Usual care
    Intervention: Behavioral: UC
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2017)
216
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2013)
375
Actual Study Completion Date  ICMJE June 30, 2018
Actual Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01761396
Other Study ID Numbers  ICMJE NA00075767
R324A120405 ( Other Grant/Funding Number: Institute of Educational Sciences (IES) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Will follow IES procedures for making de-identified data set available
Responsible Party Golda S. Ginsburg, UConn Health
Study Sponsor  ICMJE UConn Health
Collaborators  ICMJE
  • U.S. Department of Education
  • Johns Hopkins University
Investigators  ICMJE
Principal Investigator: Golda S Ginsburg, Ph.D. University of Connecticut
PRS Account UConn Health
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP