Treatment of Childhood Social Phobia

Social Phobia Clinical Trial

Official title:

Treatment of Childhood Social Phobia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00043537
• Other study ID #: R01MH053703
• Secondary ID: R01MH053703
• Status: Completed
• Phase: Phase 3
• First received: August 9, 2002
• Last updated: July 31, 2013
• Start date: April 2001
• Est. completion date: September 2006

Study information

• Verified date: July 2013
• Source: University of Central Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This 4-year study will compare the long-term effectiveness of behavioral treatment, fluoxetine (Prozac®), and placebo for treatment of social phobia in children and adolescents.

Description:

Social phobia affects 3-5 percent of children, and prevalence rises with age. Youth with social phobia fear many activities that are part of everyday life and suffer from problems such as headaches or stomachaches, panic, avoidance, general anxiety, depression, loneliness, and a very restricted range of social relationships. Recent findings indicate a new psychosocial treatment called Social Effectiveness Therapy for Children (SET-C) is effective in treating children ages 8-11, resulting in reduced emotional distress and improved social functioning. Treatment effects have been maintained for up to 6 months. This study will examine SET-C in children ages 8-15. Because available data suggest that the drug fluoxetine is a promising treatment, SET-C will be compared to fluoxetine in this trial. Durability of treatment will be monitored over a 1-year follow-up period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 16 Years

Eligibility

Inclusion Criteria:

• Diagnosis of social phobia

Exclusion Criteria:

• Pervasive developmental disorders (PDD)

• Schizophrenia

• Major Depression

• IQ of less than 80

• Medical conditions contraindicating use of fluoxetine

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phobic Disorders
• Social Phobia

Intervention

Behavioral:
• Social Effectiveness Therapy for Children (SET-C)

Drug:
• Fluoxetine

• Pill Placebo

Locations

Country	Name	City	State
United States	Maryland Center for Anxiety Disorders	University of Maryland, College Park	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Central Florida	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Beidel DC, Turner SM, Sallee FR, Ammerman RT, Crosby LA, Pathak S. SET-C versus fluoxetine in the treatment of childhood social phobia. J Am Acad Child Adolesc Psychiatry. 2007 Dec;46(12):1622-32. — View Citation