Clinical trial NCT01761396: School-based Treatment of Anxiety Research Study (STARS)
Official title: Modular CBT for Reducing Anxiety and Improving Educational Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Keywords: Anxiety
Fear
Worry
Therapy
Cognitive behavioral therapy
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
name: Johns Hopkins University
First posted: 2013-01-04
Enrollment: 216
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Clinical Global Impressions Improvement Scale
timeFrame: 12 weeks post-treatment
Secondary outcomes:
measure: School Records
timeFrame: 12 weeks post-treatment
measure: Teacher Report Form
timeFrame: 12 weeks post-treatment
Other outcomes:
measure: Screen for Child Anxiety Related Emotional Disorders
timeFrame: 12 weeks post-treatment
measure: Children's Automatic Thoughts Scale
timeFrame: 12 weeks post-treatment
measure: Woodcock-Johnson Tests of Achievement
timeFrame: 12 weeks post-treatment
measure: Children's Global Assessment Scale
timeFrame: 12 weeks post-treatment
measure: Brief Symptom Inventory
timeFrame: 12 weeks post-treatment
measure: The TCU Organizational Readiness to Change
timeFrame: 12 weeks post-treatment
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Golda S Ginsburg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.