School-based Treatment of Anxiety Research Study (STARS)

This study is enrolling participants by invitation only.
U.S. Department of Education
Johns Hopkins University
Information provided by (Responsible Party):
Golda S. Ginsburg, University of Connecticut Health Center Identifier:
First received: October 12, 2012
Last updated: February 26, 2015
Last verified: February 2015
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 University of Connecticut Health Center:

Primary Outcome Measures:
  • Anxiety Disorders Interview Schedule for DSM-IV, Parent and Child Versions [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]
    Anxiety diagnosis

Secondary Outcome Measures:
  • School Records [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]
    Academic functioning

  • Teacher Report Form [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]
    classroom behavior and performance

Other Outcome Measures:
  • Screen for Child Anxiety Related Emotional Disorders [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]
    Additional measures of symptoms, mediators, and moderators

  • Children's Automatic Thoughts Scale [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]
    Cognitive distortions related to anxiety

  • Woodcock-Johnson Tests of Achievement [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]
    Academic achievement and working memory

  • Urban Hassles Index [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]
    Exposure to community crime and violence

  • Brief Symptom Inventory [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]
    Parental psychopathology

  • The TCU Organizational Readiness to Change [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]
    Clinician's perceptions of workplace attributes

Estimated Enrollment: 375
Study Start Date: July 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (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.

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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 identifier: NCT01761396

United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
University of Connecticut Health Center
U.S. Department of Education
Johns Hopkins University
Principal Investigator: Golda S Ginsburg, Ph.D. University of Connecticut
  More Information

Responsible Party: Golda S. Ginsburg, Professor, University of Connecticut Health Center Identifier: NCT01761396     History of Changes
Other Study ID Numbers: NA00075767, R324A120405
Study First Received: October 12, 2012
Last Updated: February 26, 2015
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Connecticut Health Center:
Cognitive behavioral therapy

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders processed this record on November 27, 2015