School-based Treatment of Anxiety Research Study (STARS)
This study is enrolling participants by invitation only.
Sponsor:
Johns Hopkins University
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Golda S. Ginsburg, Ph.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01761396
First received: October 12, 2012
Last updated: September 23, 2013
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Anxiety Disorders |
Behavioral: CBT Behavioral: UC |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Modular CBT for Reducing Anxiety and Improving Educational Outcomes |
Resource links provided by NLM:
Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:
- Anxiety Disorders Interview Schedule for DSM-IV, Parent and Child Versions [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]Anxiety diagnosis
Secondary Outcome Measures:
- School Records [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]Academic functioning
- Teacher Report Form [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]classroom behavior and performance
Other Outcome Measures:
- Screen for Child Anxiety Related Emotional Disorders [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]Additional measures of symptoms, mediators, and moderators
- Children's Automatic Thoughts Scale [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]Cognitive distortions related to anxiety
- Woodcock-Johnson Tests of Achievement [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]Academic achievement and working memory
- Urban Hassles Index [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]Exposure to community crime and violence
- Brief Symptom Inventory [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]Parental psychopathology
- The TCU Organizational Readiness to Change [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]Clinician's perceptions of workplace attributes
| Estimated Enrollment: | 375 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CBT
Cognitive behavioral therapy
|
Behavioral: CBT
Other Name: Cognitive Behavioral therapy
|
|
Active Comparator: UC
Usual care
|
Behavioral: UC
Other Name: Usual Care
|
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| Ages Eligible for Study: | 7 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- between the ages of 7-17 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 or pharmacological treatment for anxiety
- victim of previously undisclosed child abuse and require ongoing Department of Social Service (DSS) supervision
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761396
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761396
Locations
| United States, Maryland | |
| Johns Hopkins University School of Medicine | |
| Baltimore, Maryland, United States, 21287 | |
Sponsors and Collaborators
Johns Hopkins University
U.S. Department of Education
Investigators
| Principal Investigator: | Golda S Ginsburg, PhD | Johns Hopkins University |
More Information
Publications:
| Responsible Party: | Golda S. Ginsburg, Ph.D., Professor, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT01761396 History of Changes |
| Other Study ID Numbers: | NA00075767, R324A120405 |
| Study First Received: | October 12, 2012 |
| Last Updated: | September 23, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Johns Hopkins University:
|
Anxiety Fear Worry Therapy Cognitive behavioral therapy |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on February 25, 2015