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Treatment of Childhood Social Phobia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00043537
Recruitment Status : Completed
First Posted : August 12, 2002
Last Update Posted : August 1, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Deborah Beidel, University of Central Florida

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Social Phobia Behavioral: Social Effectiveness Therapy for Children (SET-C) Drug: Fluoxetine Drug: Pill Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Childhood Social Phobia
Study Start Date : April 2001
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Phobias
Drug Information available for: Fluoxetine

Arm Intervention/treatment
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)
Experimental: Fluoxetine
Fluoxetine given in 10mg doses, up to 40 mg as tolerated
Drug: Fluoxetine
Placebo Comparator: Pill placebo
Capsules identical to fluoxetine given in "10 mg." doses up to 40 mg.
Drug: Pill Placebo

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00043537

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United States, Maryland
Maryland Center for Anxiety Disorders
University of Maryland, College Park, Maryland, United States, 20742
Sponsors and Collaborators
University of Central Florida
National Institute of Mental Health (NIMH)
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Deborah Beidel, Professor of Psychology, University of Central Florida Identifier: NCT00043537    
Other Study ID Numbers: R01MH053703 ( U.S. NIH Grant/Contract )
R01MH053703 ( U.S. NIH Grant/Contract )
First Posted: August 12, 2002    Key Record Dates
Last Update Posted: August 1, 2013
Last Verified: July 2013
Keywords provided by Deborah Beidel, University of Central Florida:
Phobic Disorders
Additional relevant MeSH terms:
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Phobic Disorders
Phobia, Social
Anxiety Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors