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School-based Treatment of Anxiety Research Study (STARS)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT01761396
First received: October 12, 2012
Last updated: January 3, 2013
Last verified: October 2012
History of Changes
  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
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:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

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.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • between the ages of 7-17 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 Social Service (DSS) supervision
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761396

Locations
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
U.S. Department of Education
Investigators
Principal Investigator: Golda S Ginsburg, PhD Johns Hopkins University
  More Information

Publications:

Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT01761396     History of Changes
Other Study ID Numbers: NA00075767, R324A120405
Study First Received: October 12, 2012
Last Updated: January 3, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Anxiety
Fear
Worry
Therapy
Cognitive behavioral therapy

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013