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School-based Treatment of Anxiety Research Study (STARS)

U

UConn Health

Status

Completed

Conditions

Anxiety Disorders

Treatments

Behavioral: UC
Behavioral: CBT

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01761396
R324A120405 (Other Grant/Funding Number)
NA00075767

Details and patient eligibility

About

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.

Full 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.

Enrollment

216 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

216 participants in 2 patient groups

CBT
Experimental group
Description:
Cognitive behavioral therapy
Treatment:
Behavioral: CBT
UC
Active Comparator group
Description:
Usual care
Treatment:
Behavioral: UC

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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