NCT01320800

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

January 29, 2016

Status Verified

January 1, 2016

Enrollment Period

4.3 years

First QC Date

March 11, 2011

Last Update Submit

January 28, 2016

Conditions

Social Anxiety Disorder

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (3)

  • Change in Diagnostic status: presence or absence of social anxiety disorder

    2 week and 6-month follow-up

  • 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

  • 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

Study Arms (3)

Expert-led CBT

ACTIVE COMPARATOR

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

Behavioral: Skills for Academic and Social Success

School Counselor-led CBT

EXPERIMENTAL

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

Skills for Life

ACTIVE COMPARATOR

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

Behavioral: Skills for Life

Interventions

Skills for Academic and Social SuccessBEHAVIORAL

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

Expert-led CBTSchool Counselor-led CBT
Skills for LifeBEHAVIORAL

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

Skills for Life

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

  • 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.

    PMID: 27002215DERIVED

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Carrie Masia, Ph.D.

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 22, 2011

Study Start

October 1, 2010

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

January 29, 2016

Record last verified: 2016-01

Locations

US(1)