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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Behavioral: CBT Behavioral: UC Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modular CBT for Reducing Anxiety and Improving Educational Outcomes
Actual Study Start Date : July 2012
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: CBT
Cognitive behavioral therapy
 Behavioral: CBT
Other Name: Cognitive Behavioral therapy
Active Comparator: UC
Usual care
 Behavioral: UC
Other Name: Usual Care


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Global Impressions Improvement Scale [ Time Frame: 12 weeks post-treatment ]
    Improvement in Clinical Anxiety Diagnosis


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

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


Other Outcome Measures:
  1. Screen for Child Anxiety Related Emotional Disorders [ Time Frame: 12 weeks post-treatment ]
    Additional measures of symptoms, mediators, and moderators

  2. Children's Automatic Thoughts Scale [ Time Frame: 12 weeks post-treatment ]
    Cognitive distortions related to anxiety

  3. Woodcock-Johnson Tests of Achievement [ Time Frame: 12 weeks post-treatment ]
    Academic achievement and working memory

  4. Children's Global Assessment Scale [ Time Frame: 12 weeks post-treatment ]
    Global Functioning

  5. Brief Symptom Inventory [ Time Frame: 12 weeks post-treatment ]
    Parental psychopathology

  6. The TCU Organizational Readiness to Change [ Time Frame: 12 weeks post-treatment ]
    Clinician's perceptions of workplace attributes


Eligibility Criteria
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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 treatment for anxiety
  • victim of previously undisclosed child abuse and require ongoing Department of Children and Families (DCF) supervision
Contacts and Locations
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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
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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
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Principal Investigator: Golda S Ginsburg, Ph.D. University of Connecticut
More Information
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Publications:

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Responsible Party: Golda S. Ginsburg, Professor, UConn Health
ClinicalTrials.gov Identifier: NCT01761396    
Other Study ID Numbers: NA00075767
R324A120405 ( Other Grant/Funding Number: Institute of Educational Sciences (IES) )
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Will follow IES procedures for making de-identified data set available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Golda S. Ginsburg, UConn Health:
Anxiety
Fear
Worry
Therapy
Cognitive behavioral therapy
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders