Social Anxiety DisorderPhase 2NCT01320800
CBT for Social Anxiety Disorder Delivered by School Counselors
A Phase 2 study testing Skills for Academic and Social Success and Skills for Life in people with Social Anxiety Disorder, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Skills for Academic and Social Success and Skills for Life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Feb 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
Read the 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.
- Conditions
- Social Anxiety Disorder
- Being tested
- Skills for Academic and Social Success, Skills for Life
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skills for Academic and Social SuccessBehavioural
12-week cognitive-behavioral, school-based group intervention
Skills for LifeBehavioural
SFL is the Skills for Life Protocol delivered by school counselors.
| Study group | Role | What they receive |
|---|---|---|
| Expert-led CBT | Active comparator | Expert SASS is the Skills for Academic and Social Success protocol delivered by a postdoctoral fellows. Receives: 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 Receives: 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 Receives: Behavioral: Skills for Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 week and 6-month follow-up
Secondary outcomes (3)
Change in Diagnostic status: presence or absence of social anxiety disorder
Measured: 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
Measured: 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)
Measured: 2 week and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startOct 2010
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Carrie Masia, Ph.D., Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320800
- Sponsor's protocol ID
- MH81881
- Other IDs
- R01MH081881
- Status last verified
- Jan 2016
- First submitted
- 11 Mar 2011
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27002215
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBT for Social Anxiety Disorder Delivered by School Counselors
- ClinicalTrials.gov ID
- NCT01320800
- Acronym / sponsor ID
- MH81881
- Conditions
- Social Anxiety Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 22 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Expert-led CBT | Active comparator | Behavioral: Skills for Academic and Social SuccessExpert SASS is the Skills for Academic and Social Success protocol delivered by a postdoctoral fellows. |
| School Counselor-led CBT | Experimental | Behavioral: Skills for Academic and Social SuccessSchool Counselor SASS is the Skills for Academic and Social Success protocol delivered by School Counselors. Intervention: Behavioral: Skills for Social and Academic Success |
| Skills for Life | Active comparator | Behavioral: Skills for LifeSFL is the Skills for Life Protocol delivered by school counselors. Intervention: Behavioral: Skills for Life |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skills for Academic and Social Success12-week cognitive-behavioral, school-based group intervention | Behavioural | Expert-led CBT, School Counselor-led CBT |
| Skills for LifeSFL is the Skills for Life Protocol delivered by school counselors. | Behavioural | Skills for Life |
Primary outcome
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.
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.
3 secondary outcomes
Change in Diagnostic status: presence or absence of social anxiety disorder
Time frame: 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
Time frame: 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)
Time frame: 2 week and 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
- Derived from this study: PubMed 27002215Masia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie Masia, Ph.D. principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Skills for Academic and Social Success and Skills for Life in people with Social Anxiety Disorder, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diagnostic severity of social anxiety disorder (ADIS CSR score) (time frame: 2 week and 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01320800, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2016.