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CBT for Social Anxiety Disorder Delivered by School Counselors

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT01320800
Collaborator
National Institute of Mental Health (NIMH) (NIH)
126
Enrollment
1
Location
3
Arms
52
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

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
  • 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
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 :
Oct 1, 2010
Actual Primary Completion Date :
Feb 1, 2015
Actual Study Completion Date :
Feb 1, 2015

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) [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) [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 [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 [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) [2 week and 6-month follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 New York University School of Medicine New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Carrie Masia, Ph.D., NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT01320800
Other Study ID Numbers:
  • MH81881
  • R01MH081881
  • NCT01892735
First Posted:
Mar 22, 2011
Last Update Posted:
Jan 29, 2016
Last Verified:
Jan 1, 2016
Additional relevant MeSH terms:
Anxiety Disorders
Phobia, Social

Study Results

No Results Posted as of Jan 29, 2016