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Treatment of Childhood Social Phobia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00043537
First Posted: August 12, 2002
Last Update Posted: August 1, 2013
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.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Deborah Beidel, University of Central Florida
  Purpose
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 Intervention Phase
Social Phobia Behavioral: Social Effectiveness Therapy for Children (SET-C) Drug: Fluoxetine Drug: Pill Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Childhood Social Phobia

Resource links provided by NLM:


Further study details as provided by Deborah Beidel, University of Central Florida:

Enrollment: 139
Study Start Date: April 2001
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00043537


Locations
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)
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deborah Beidel, Professor of Psychology, University of Central Florida
ClinicalTrials.gov Identifier: NCT00043537     History of Changes
Other Study ID Numbers: R01MH053703 ( U.S. NIH Grant/Contract )
First Submitted: August 9, 2002
First Posted: August 12, 2002
Last Update Posted: August 1, 2013
Last Verified: July 2013

Keywords provided by Deborah Beidel, University of Central Florida:
Phobic Disorders
Mutism

Additional relevant MeSH terms:
Phobic Disorders
Phobia, Social
Anxiety Disorders
Mental Disorders
Fluoxetine
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