School-based Treatment of Anxiety Research Study (STARS) | NCT01761396

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

NCT01761396

Sponsor

UConn Health

Status

Completed

Last Update Posted

Jan 8, 2019Actual

Enrollment

216Actual

Phase

Not Applicable

Conditions

Anxiety Disorders

Interventions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R324A120405	Other Grant/Funding Number	Institute of Educational Sciences (IES)

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012Actual

Primary Completion Date

May 1, 2018Actual

Completion Date

Jun 30, 2018Actual

First Submitted Date

Oct 12, 2012

First Submission Date that Met QC Criteria

Jan 3, 2013

First Posted Date

Jan 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2019

Last Update Posted Date

Jan 8, 2019Actual

Name	Class
U.S. Department of Education	FED
Johns Hopkins University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

216Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CBT	Experimental	Cognitive behavioral therapy	Behavioral: CBT
UC	Active Comparator	Usual care	Behavioral: UC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CBT	Behavioral		CBT	Cognitive Behavioral therapy
UC

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Golda S Ginsburg, Ph.D.	University of Connecticut	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Connecticut Health Center		Farmington	Connecticut	06030	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22701295	Background	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.

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities