Official Title
Treatment of Childhood Social Phobia
Phase
Phase 3Lead Sponsor
University of Central FloridaStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Social PhobiaIntervention/Treatment
fluoxetine ...Study Participants
139This 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.
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.
Social Effectiveness Therapy for Children includes social skills training, peer generalization experiences and exposure therapy
Capsules identical to fluoxetine given in "10 mg." doses up to 40 mg.
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
