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

Modular CBT for Reducing Anxiety and Improving Educational Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders
• Intervention / Treatment: Behavioral: CBT; Behavioral: UC

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 Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT; Cognitive behavioral therapy	Behavioral: CBT; Other Names: Cognitive Behavioral therapy
Active Comparator: UC; Usual care	Behavioral: UC; Other Names: Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impressions Improvement Scale	Improvement in Clinical Anxiety Diagnosis	12 weeks post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
School Records	Academic functioning	12 weeks post-treatment
Teacher Report Form	classroom behavior and performance	12 weeks post-treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screen for Child Anxiety Related Emotional Disorders	Additional measures of symptoms, mediators, and moderators	12 weeks post-treatment
Children's Automatic Thoughts Scale	Cognitive distortions related to anxiety	12 weeks post-treatment
Woodcock-Johnson Tests of Achievement	Academic achievement and working memory	12 weeks post-treatment
Children's Global Assessment Scale	Global Functioning	12 weeks post-treatment
Brief Symptom Inventory	Parental psychopathology	12 weeks post-treatment
The TCU Organizational Readiness to Change	Clinician's perceptions of workplace attributes	12 weeks post-treatment

Collaborators and Investigators

• Sponsor: UConn Health
• Collaborators: Johns Hopkins University; U.S. Department of Education
• Investigators: Principal Investigator: Golda S Ginsburg, Ph.D., University of Connecticut

Publications and helpful links

General Publications

• 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. doi: 10.1007/s10566-011-9156-4.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: October 12, 2012
• First Submitted That Met QC Criteria: January 3, 2013
• First Posted (Estimate): January 4, 2013

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: January 7, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Anxiety; Cognitive behavioral therapy; Therapy; Fear; Worry
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: NA00075767; R324A120405 (Other Grant/Funding Number: Institute of Educational Sciences (IES))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Will follow IES procedures for making de-identified data set available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No