Treatment of Childhood Social Phobia

Phase 3

Completed

• Conditions: Social Phobia
• Interventions: Behavioral: Social Effectiveness Therapy for Children (SET-C); Drug: Pill Placebo; Drug: Fluoxetine

• Registration Number: NCT00043537
• Lead Sponsor: University of Central Florida

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2002-08-09
• Study First Submitted QC: 2002-08-09
• Study First Posted: 2002-08-12
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-31
• Last Update Posted: 2013-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

• Diagnosis of social phobia

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Exclusion Criteria

• Pervasive developmental disorders (PDD)
• Schizophrenia
• Major Depression
• IQ of less than 80
• Medical conditions contraindicating use of fluoxetine

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Social Effectiveness Therapy for Children	Social Effectiveness Therapy for Children (SET-C)	Social Effectiveness Therapy for Children includes social skills training, peer generalization experiences and exposure therapy
Pill placebo	Pill Placebo	Capsules identical to fluoxetine given in "10 mg." doses up to 40 mg.
Fluoxetine	Fluoxetine	Fluoxetine given in 10mg doses, up to 40 mg as tolerated

Trial Locations

Locations (1)

Maryland Center for Anxiety Disorders; 🇺🇸 University of Maryland, College Park, Maryland, United States