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CBT for Social Anxiety Disorder Delivered by School Counselors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01320800
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : January 29, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Social Anxiety Disorder Behavioral: Skills for Academic and Social Success Behavioral: Skills for Life Phase 2

Detailed Description:
The investigators have tested SASS, a school-based group CBT intervention for social phobia, and found it to be effective when delivered by psychologists (Masia Warner et al., 2005; Masia Warner et al., 2007). The proposed dissemination study extends this work through a controlled trial of SASS delivered by school counselors. The investigators will randomize 126 adolescents with social anxiety disorder, ages 14 through 17, to one of 3 treatments: 1) SASS delivered by school counselors (SC-SASS), 2) SASS delivered by psychologists (Expert-SASS), or 3) a manualized adolescent group counseling program specifically designed for school counselors, called Skills for Living (SFL). A comprehensive evaluation will include diagnosis, illness severity, scale ratings of social anxiety and depression, clinical global improvement, overall functioning, and school-relevant indices of function. Outcomes will be assessed at baseline, mid-point (after 6 weeks of intervention), post-treatment, and 6 months following intervention completion.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: CBT for Social Anxiety Disorder Delivered by School Counselors
Study Start Date : October 2010
Primary Completion Date : February 2015
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Expert-led CBT
Expert SASS is the Skills for Academic and Social Success protocol delivered by a postdoctoral fellows.
Behavioral: Skills for Academic and Social Success
12-week cognitive-behavioral, school-based group intervention
Experimental: School Counselor-led CBT

School Counselor SASS is the Skills for Academic and Social Success protocol delivered by School Counselors.

Intervention: Behavioral: Skills for Social and Academic Success

Behavioral: Skills for Academic and Social Success
12-week cognitive-behavioral, school-based group intervention
Active Comparator: Skills for Life
SFL is the Skills for Life Protocol delivered by school counselors. Intervention: Behavioral: Skills for Life
Behavioral: Skills for Life
SFL is the Skills for Life Protocol delivered by school counselors.


Outcome Measures

Primary Outcome Measures :
  1. Change in Diagnostic severity of social anxiety disorder (ADIS CSR score) [ Time Frame: 2 week and 6-month follow-up ]
    ADIS CSR Ratings are taken at baseline, immediately following treatment, and at a 6-month followup.

  2. Change in Treatment response/non-response (a CGI-I of Improved or better, ratings of 1-3, 3 = Improved) [ Time Frame: 2 week and 6-month follow-up ]
    CGI-I assesses improvement from baseline immediately following treatment and at a 6-month followup assessment.


Secondary Outcome Measures :
  1. Change in Diagnostic status: presence or absence of social anxiety disorder [ Time Frame: 2 week and 6-month follow-up ]
  2. Change in Overall and school functioning: spare-time, peer relations, home life, school attendance, grades, and LSAS-CA school items total score [ Time Frame: 2 week and 6-month follow-up ]
  3. 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: 2 week and 6-month follow-up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Carrie Masia, Ph.D. New York University School of Medicine
More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01320800     History of Changes
Obsolete Identifiers: NCT01892735
Other Study ID Numbers: MH81881
R01MH081881 ( U.S. NIH Grant/Contract )
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Phobia, Social
Pathologic Processes
Mental Disorders
Phobic Disorders