Treatment of Childhood Social Phobia

July 31, 2013 updated by: Deborah Beidel, University of Central Florida
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • University of Maryland, College Park, Maryland, United States, 20742
        • Maryland Center for Anxiety Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 16 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Central Florida

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (ACTUAL)

September 1, 2006

Study Completion (ACTUAL)

September 1, 2006

Study Registration Dates

First Submitted

August 9, 2002

First Submitted That Met QC Criteria

August 9, 2002

First Posted (ESTIMATE)

August 12, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

August 1, 2013

Last Update Submitted That Met QC Criteria

July 31, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH053703 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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