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CBT for Social Anxiety Disorder Delivered by School Counselors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Carrie Masia, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01320800
First received: March 11, 2011
Last updated: November 11, 2013
Last verified: November 2013
  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
Behavioral: Skills for Academic and Social Success
Behavioral: Skills for Life
Phase 2

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

Resource links provided by NLM:


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: 2 week and 6-month follow-up ] [ Designated as safety issue: No ]
    ADIS CSR Ratings are taken at baseline, immediately following treatment, and at a 6-month followup.

  • 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 ] [ Designated as safety issue: No ]
    CGI-I assesses improvement from baseline immediately following treatment and at a 6-month followup assessment.


Secondary Outcome Measures:
  • Change in Diagnostic status: presence or absence of social anxiety disorder [ Time Frame: 2 week and 6-month follow-up ] [ 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: 2 week and 6-month follow-up ] [ 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: 2 week and 6-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: October 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  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
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: 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
Investigators
Principal Investigator: Carrie Masia, Ph.D. 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
Obsolete Identifiers: NCT01892735
Other Study ID Numbers: MH81881, R01MH081881
Study First Received: March 11, 2011
Last Updated: November 11, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014