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Completed

NCT Number: NCT01320800

CBT for Social Anxiety Disorder Delivered by School Counselors

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.

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Key information

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skills for Academic and Social Success

Behavioral

12-week cognitive-behavioral, school-based group intervention

Skills for Life

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Mar 22, 2011
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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