School-based Treatment of Anxiety Research Study (STARS) (STARS)

• ClinicalTrials.gov Identifier: NCT01761396
• Recruitment Status: Completed
• First Posted: January 4, 2013
• Last Update Posted: January 8, 2019
• Sponsor: UConn Health
• Collaborators: U.S. Department of Education; Johns Hopkins University
• Information provided by (Responsible Party): Golda S. Ginsburg, UConn Health

Tracking Information

• First Submitted Date: October 12, 2012
• First Posted Date: January 4, 2013
• Last Update Posted Date: January 8, 2019
• Actual Study Start Date: July 2012
• Actual Primary Completion Date: May 1, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 23, 2018)

Clinical Global Impressions Improvement Scale [ Time Frame: 12 weeks post-treatment ]

Improvement in Clinical Anxiety Diagnosis

Original Primary Outcome Measures (submitted: January 3, 2013)

Anxiety Disorders Interview Schedule for DSM-IV, Parent and Child Versions [ Time Frame: 12 weeks post-treatment ]

Anxiety diagnosis

Current Secondary Outcome Measures (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: 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: School-based Treatment of Anxiety Research Study (STARS)
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Anxiety Disorders

Intervention

• Behavioral: CBT
  Other Name: Cognitive Behavioral therapy
• Behavioral: UC
  Other Name: Usual Care

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 23, 2017): 216
• Original Estimated Enrollment (submitted: January 3, 2013): 375
• Actual Study Completion Date: June 30, 2018
• Actual Primary Completion Date: May 1, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01761396
• Other Study ID Numbers: 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

• 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: UConn Health

Collaborators

• U.S. Department of Education
• Johns Hopkins University

Investigators

• Principal Investigator: Golda S Ginsburg, Ph.D.; University of Connecticut

• PRS Account: UConn Health
• Verification Date: January 2019