Text Size

CBT for Social Anxiety Disorder Delivered by School Counselors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Carrie Masia, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01320800
First received: March 11, 2011
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  Purpose

This 5-year study addresses the unmet needs of adolescents with social phobia through the testing of a 12-week cognitive-behavioral, school-based group intervention delivered by trained school counselors compared to a nonspecific school counseling program. A secondary goal is to provide further examination of the efficacy of the CBT program delivered by school counselors as compared to the same program delivered by psychologists.


Condition Intervention Phase
Social Anxiety Disorder
 Other: CBT for Social Anxiety Disorder
Other: Non-Specific Counseling Group
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: CBT for Social Anxiety Disorder Delivered by School Counselors

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Change in Diagnostic severity of social anxiety disorder (ADIS CSR score) [ Time Frame: Within approximately two weeks following treatment ] [ Designated as safety issue: No ]
  • Change in Treatment response/non-response (a CGI-I of Improved or better, ratings of 1-3, 3 = Improved) [ Time Frame: Within approximately two weeks following treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Diagnostic status: presence or absence of social anxiety disorder [ Time Frame: Within approximately two weeks following treatment ] [ Designated as safety issue: No ]
  • Change in Overall and school functioning: spare-time, peer relations, home life, school attendance, grades, and LSAS-CA school items total score [ Time Frame: Within approximately two weeks following treatment ] [ Designated as safety issue: No ]
  • Change in Adolescent and parent ratings of social anxiety scale scores (self and parent SPAI-C), and adolescent ratings of depression (BDI-II) [ Time Frame: Within approximately two weeks following treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: October 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Expert-led CBT Other: CBT for Social Anxiety Disorder
12-week cognitive-behavioral, school-based group intervention
Experimental: School Counselor-led CBT Other: CBT for Social Anxiety Disorder
12-week cognitive-behavioral, school-based group intervention
Active Comparator: Non-Specific Counseling Group Other: Non-Specific Counseling Group
12-week nonspecific school counseling program

  Eligibility

Ages Eligible for Study:   14 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis. DSM-IV primary diagnosis (most severe) of social anxiety disorder (as determined by the ADIS-PC)
  2. Age and Sex. Boys and Girls, 14 through 19 years
  3. Grade. 9th, 10th, 11th, or 12th
  4. English speaking. Adolescent

Exclusion Criteria:

  1. Current diagnosis of substance use or conduct disorder
  2. Concurrent mental disorder of greater severity than social anxiety disorder
  3. Current psychotic symptoms
  4. Current suicidal ideation
  5. Pervasive developmental disorder, or a significant medical disorder (e.g., substantially impairs functioning, school attendance, or the ability to engage in treatment)
  6. Current psychological or pharmacological treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320800

Locations
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
  More Information

No publications provided

Responsible Party: Carrie Masia, Associate Professor of Child and Adolescent Psychiatry and Pediatrics, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01320800     History of Changes
Other Study ID Numbers: MH81881
Study First Received: March 11, 2011
Last Updated: April 30, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013