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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01761396
First Posted: January 4, 2013
Last Update Posted: March 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
U.S. Department of Education
Johns Hopkins University
Information provided by (Responsible Party):
Golda S. Ginsburg, UConn Health
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Single (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 Golda S. Ginsburg, UConn Health:

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


Secondary Outcome Measures:
  • School Records [ Time Frame: 12 weeks post-treatment ]
    Academic functioning

  • Teacher Report Form [ Time Frame: 12 weeks post-treatment ]
    classroom behavior and performance


Other Outcome Measures:
  • 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


Enrollment: 216
Actual Study Start Date: July 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: August 2017 (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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 or pharmacological treatment for anxiety
  • victim of previously undisclosed child abuse and require ongoing Department of Children and Families (DCF) supervision
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761396


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

Publications:
Responsible Party: Golda S. Ginsburg, Professor, UConn Health
ClinicalTrials.gov Identifier: NCT01761396     History of Changes
Other Study ID Numbers: NA00075767
R324A120405 ( Other Grant/Funding Number: Institute of Educational Sciences (IES) )
First Submitted: October 12, 2012
First Posted: January 4, 2013
Last Update Posted: March 24, 2017
Last Verified: February 2015

Keywords provided by Golda S. Ginsburg, UConn Health:
Anxiety
Fear
Worry
Therapy
Cognitive behavioral therapy

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders