School-based Treatment of Anxiety Research Study (STARS)

Anxiety Disorders Clinical Trial

— STARS  

Official title:

Modular CBT for Reducing Anxiety and Improving Educational Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01761396
• Other study ID #: NA00075767
• Secondary ID: R324A120405
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: June 30, 2018

Study information

• Verified date: January 2019
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: June 30, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• CBT

• UC

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
UConn Health	Johns Hopkins University, U.S. Department of Education

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Screen for Child Anxiety Related Emotional Disorders	Additional measures of symptoms, mediators, and moderators	12 weeks post-treatment
Other	Children's Automatic Thoughts Scale	Cognitive distortions related to anxiety	12 weeks post-treatment
Other	Woodcock-Johnson Tests of Achievement	Academic achievement and working memory	12 weeks post-treatment
Other	Children's Global Assessment Scale	Global Functioning	12 weeks post-treatment
Other	Brief Symptom Inventory	Parental psychopathology	12 weeks post-treatment
Other	The TCU Organizational Readiness to Change	Clinician's perceptions of workplace attributes	12 weeks post-treatment
Primary	Clinical Global Impressions Improvement Scale	Improvement in Clinical Anxiety Diagnosis	12 weeks post-treatment
Secondary	School Records	Academic functioning	12 weeks post-treatment
Secondary	Teacher Report Form	classroom behavior and performance	12 weeks post-treatment