School-based Treatment of Anxiety Research Study (STARS)

NCT ID: NCT01761396

Last Updated: 2019-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CBT

Cognitive behavioral therapy

Group Type EXPERIMENTAL

CBT

Intervention Type BEHAVIORAL

UC

Usual care

Group Type ACTIVE_COMPARATOR

UC

Intervention Type BEHAVIORAL

Interventions

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CBT

Intervention Type BEHAVIORAL

UC

Intervention Type BEHAVIORAL

Other Intervention Names

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Cognitive Behavioral therapy Usual Care

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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U.S. Department of Education

FED

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

UConn Health

OTHER

Sponsor Role lead

Responsible Party

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Golda S. Ginsburg

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Golda S Ginsburg, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

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University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22701295 (View on PubMed)

Other Identifiers

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R324A120405

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NA00075767

Identifier Type: -

Identifier Source: org_study_id

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