Treatment of Childhood Social Phobia
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.
Behavioral: Social Effectiveness Therapy for Children (SET-C)
Drug: Pill Placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Treatment of Childhood Social Phobia|
|Study Start Date:||April 2001|
|Study Completion Date:||September 2006|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
Experimental: Social Effectiveness Therapy for Children
Social Effectiveness Therapy for Children includes social skills training, peer generalization experiences and exposure therapy
|Behavioral: Social Effectiveness Therapy for Children (SET-C)|
Fluoxetine given in 10mg doses, up to 40 mg as tolerated
Placebo Comparator: Pill placebo
Capsules identical to fluoxetine given in "10 mg." doses up to 40 mg.
|Drug: Pill Placebo|
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.
|United States, Maryland|
|Maryland Center for Anxiety Disorders|
|University of Maryland, College Park, Maryland, United States, 20742|