Treatment of Childhood Social Phobia

Condition(s) targeted: Social Phobia

Intervention: Social Effectiveness Therapy for Children (SET-C) (Behavioral); Fluoxetine (Drug); Pill Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: National Institute of Mental Health (NIMH)

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.

Official title: Treatment of Childhood Social Phobia

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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.

Minimum age: 8 Years. Maximum age: 16 Years. Gender(s): Both.

Criteria:

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

Maryland Center for Anxiety Disorders, University of Maryland, College Park, Maryland 20742, United States

Starting date: April 2001
Ending date: September 2006
Last updated: February 28, 2008