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CBT for Social Anxiety Disorder Delivered by School Counselors

Primary Purpose

Social Anxiety Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Skills for Academic and Social Success
Skills for Life
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder

Eligibility Criteria

14 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Expert-led CBT

School Counselor-led CBT

Skills for Life

Arm Description

Expert SASS is the Skills for Academic and Social Success protocol delivered by a postdoctoral fellows.

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

SFL is the Skills for Life Protocol delivered by school counselors. Intervention: Behavioral: Skills for Life

Outcomes

Primary Outcome Measures

Change in Diagnostic severity of social anxiety disorder (ADIS CSR score)
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)
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
Change in Overall and school functioning: spare-time, peer relations, home life, school attendance, grades, and LSAS-CA school items total score
Change in Adolescent and parent ratings of social anxiety scale scores (self and parent SPAI-C), and adolescent ratings of depression (BDI-II)

Full Information

First Posted
March 11, 2011
Last Updated
January 28, 2016
Sponsor
NYU Langone Health
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01320800
Brief Title
CBT for Social Anxiety Disorder Delivered by School Counselors
Official Title
CBT for Social Anxiety Disorder Delivered by School Counselors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expert-led CBT
Arm Type
Active Comparator
Arm Description
Expert SASS is the Skills for Academic and Social Success protocol delivered by a postdoctoral fellows.
Arm Title
School Counselor-led CBT
Arm Type
Experimental
Arm Description
School Counselor SASS is the Skills for Academic and Social Success protocol delivered by School Counselors. Intervention: Behavioral: Skills for Social and Academic Success
Arm Title
Skills for Life
Arm Type
Active Comparator
Arm Description
SFL is the Skills for Life Protocol delivered by school counselors. Intervention: Behavioral: Skills for Life
Intervention Type
Behavioral
Intervention Name(s)
Skills for Academic and Social Success
Intervention Description
12-week cognitive-behavioral, school-based group intervention
Intervention Type
Behavioral
Intervention Name(s)
Skills for Life
Intervention Description
SFL is the Skills for Life Protocol delivered by school counselors.
Primary Outcome Measure Information:
Title
Change in Diagnostic severity of social anxiety disorder (ADIS CSR score)
Description
ADIS CSR Ratings are taken at baseline, immediately following treatment, and at a 6-month followup.
Time Frame
2 week and 6-month follow-up
Title
Change in Treatment response/non-response (a CGI-I of Improved or better, ratings of 1-3, 3 = Improved)
Description
CGI-I assesses improvement from baseline immediately following treatment and at a 6-month followup assessment.
Time Frame
2 week and 6-month follow-up
Secondary Outcome Measure Information:
Title
Change in Diagnostic status: presence or absence of social anxiety disorder
Time Frame
2 week and 6-month follow-up
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis. DSM-IV primary diagnosis (most severe) of social anxiety disorder (as determined by the ADIS-PC) Age and Sex. Boys and Girls, 14 through 19 years Grade. 9th, 10th, 11th, or 12th English speaking. Adolescent Exclusion Criteria: Current diagnosis of substance use or conduct disorder Concurrent mental disorder of greater severity than social anxiety disorder Current psychotic symptoms Current suicidal ideation Pervasive developmental disorder, or a significant medical disorder (e.g., substantially impairs functioning, school attendance, or the ability to engage in treatment) Current psychological or pharmacological treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carrie Masia, Ph.D.
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27002215
Citation
Masia Warner C, Colognori D, Brice C, Herzig K, Mufson L, Lynch C, Reiss PT, Petkova E, Fox J, Moceri DC, Ryan J, Klein RG. Can school counselors deliver cognitive-behavioral treatment for social anxiety effectively? A randomized controlled trial. J Child Psychol Psychiatry. 2016 Nov;57(11):1229-1238. doi: 10.1111/jcpp.12550. Epub 2016 Mar 22.
Results Reference
derived

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CBT for Social Anxiety Disorder Delivered by School Counselors

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