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.

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Key information

Conditions

Social Phobia Anxiety Disorders Communication Disorders Language Disorders Mental Disorders Mutism Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Phobia, Social Phobic Disorders Signs and Symptoms Speech Disorders

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Maryland Center for Anxiety Disorders

University of Maryland, College Park, Maryland, 20742, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social Effectiveness Therapy for Children (SET-C)

Behavioral

Fluoxetine

Drug

Pill Placebo

Drug

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Collaborators

National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start: 2001
Primary completion: 2006
Study completion: 2006
First posted: Aug 12, 2002
Registry last updated: Aug 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed