Skip to content

School-based Treatment of Anxiety Research Study (STARS)

Modular CBT for Reducing Anxiety and Improving Educational Outcomes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01761396
Acronym
STARS
Enrollment
216
Registered
2013-01-04
Start date
2012-07-31
Completion date
2018-06-30
Last updated
2019-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders

Keywords

Anxiety, Fear, Worry, Therapy, Cognitive behavioral therapy

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.

Interventions

BEHAVIORALCBT
BEHAVIORALUC

Sponsors

U.S. Department of Education
CollaboratorFED
Johns Hopkins University
CollaboratorOTHER
UConn Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical Global Impressions Improvement Scale12 weeks post-treatmentImprovement in Clinical Anxiety Diagnosis

Secondary

MeasureTime frameDescription
School Records12 weeks post-treatmentAcademic functioning
Teacher Report Form12 weeks post-treatmentclassroom behavior and performance

Other

MeasureTime frameDescription
Children's Global Assessment Scale12 weeks post-treatmentGlobal Functioning
Screen for Child Anxiety Related Emotional Disorders12 weeks post-treatmentAdditional measures of symptoms, mediators, and moderators
The TCU Organizational Readiness to Change12 weeks post-treatmentClinician's perceptions of workplace attributes
Brief Symptom Inventory12 weeks post-treatmentParental psychopathology
Children's Automatic Thoughts Scale12 weeks post-treatmentCognitive distortions related to anxiety
Woodcock-Johnson Tests of Achievement12 weeks post-treatmentAcademic achievement and working memory

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026