Clinical trial NCT01320800: CBT for Social Anxiety Disorder Delivered by School Counselors
Official title: CBT for Social Anxiety Disorder Delivered by School Counselors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Social Anxiety Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2011-03-22
Enrollment: 126
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Diagnostic severity of social anxiety disorder (ADIS CSR score)
timeFrame: 2 week and 6-month follow-up
measure: Change in Treatment response/non-response (a CGI-I of Improved or better, ratings of 1-3, 3 = Improved)
timeFrame: 2 week and 6-month follow-up
Secondary outcomes:
measure: Change in Diagnostic status: presence or absence of social anxiety disorder
timeFrame: 2 week and 6-month follow-up
measure: Change in Overall and school functioning: spare-time, peer relations, home life, school attendance, grades, and LSAS-CA school items total score
timeFrame: 2 week and 6-month follow-up
measure: Change in Adolescent and parent ratings of social anxiety scale scores (self and parent SPAI-C), and adolescent ratings of depression (BDI-II)
timeFrame: 2 week and 6-month follow-up
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Carrie Masia, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.