CBT for Social Anxiety Disorder Delivered by School Counselors

Social Anxiety Disorder Clinical Trial

Official title:

CBT for Social Anxiety Disorder Delivered by School Counselors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320800
• Other study ID #: MH81881
• Secondary ID: R01MH081881
• Status: Completed
• Phase: Phase 2
• First received: March 11, 2011
• Last updated: January 28, 2016
• Start date: October 2010
• Est. completion date: February 2015

Study information

• Verified date: January 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01892735

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobic Disorders
• Social Anxiety Disorder

Intervention

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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 week and 6-month follow-up	No
Primary	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.	2 week and 6-month follow-up	No
Secondary	Change in Diagnostic status: presence or absence of social anxiety disorder		2 week and 6-month follow-up	No
Secondary	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	No
Secondary	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	No