Treatment of Childhood Social Phobia

University of Central Florida

Status and phase: Completed; Phase 3

Conditions: Social Phobia

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00043537

R01MH053703 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 139 patients

Sex: All

Ages: 8 to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

139 participants in 3 patient groups, including a placebo group

Social Effectiveness Therapy for Children

Experimental group

Description:

Social Effectiveness Therapy for Children includes social skills training, peer generalization experiences and exposure therapy

Treatment:

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

Fluoxetine

Experimental group

Description:

Fluoxetine given in 10mg doses, up to 40 mg as tolerated

Treatment:

Drug: Fluoxetine

Pill placebo

Placebo Comparator group

Description:

Capsules identical to fluoxetine given in "10 mg." doses up to 40 mg.

Treatment:

Drug: Pill Placebo