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Treatment of Childhood Social Phobia

Primary Purpose

Social Phobia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Social Effectiveness Therapy for Children (SET-C)
Fluoxetine
Pill Placebo
Sponsored by
University of Central Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Phobia focused on measuring Phobic Disorders, Mutism

Eligibility Criteria

8 Years - 16 Years (Child)All SexesAccepts 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

Sites / Locations

  • Maryland Center for Anxiety Disorders

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Social Effectiveness Therapy for Children

Fluoxetine

Pill placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 9, 2002
Last Updated
July 31, 2013
Sponsor
University of Central Florida
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00043537
Brief Title
Treatment of Childhood Social Phobia
Official Title
Treatment of Childhood Social Phobia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Central Florida
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia
Keywords
Phobic Disorders, Mutism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Social Effectiveness Therapy for Children
Arm Type
Experimental
Arm Description
Social Effectiveness Therapy for Children includes social skills training, peer generalization experiences and exposure therapy
Arm Title
Fluoxetine
Arm Type
Experimental
Arm Description
Fluoxetine given in 10mg doses, up to 40 mg as tolerated
Arm Title
Pill placebo
Arm Type
Placebo Comparator
Arm Description
Capsules identical to fluoxetine given in "10 mg." doses up to 40 mg.
Intervention Type
Behavioral
Intervention Name(s)
Social Effectiveness Therapy for Children (SET-C)
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Intervention Type
Drug
Intervention Name(s)
Pill Placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Maryland Center for Anxiety Disorders
City
University of Maryland, College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18030084
Citation
Beidel DC, Turner SM, Sallee FR, Ammerman RT, Crosby LA, Pathak S. SET-C versus fluoxetine in the treatment of childhood social phobia. J Am Acad Child Adolesc Psychiatry. 2007 Dec;46(12):1622-32. doi: 10.1097/chi.0b013e318154bb57.
Results Reference
result
PubMed Identifier
21391024
Citation
De Los Reyes A, Alfano CA, Beidel DC. Are clinicians' assessments of improvements in children's functioning "global"? J Clin Child Adolesc Psychol. 2011;40(2):281-94. doi: 10.1080/15374416.2011.546043.
Results Reference
derived
PubMed Identifier
20013046
Citation
De Los Reyes A, Alfano CA, Beidel DC. The relations among measurements of informant discrepancies within a multisite trial of treatments for childhood social phobia. J Abnorm Child Psychol. 2010 Apr;38(3):395-404. doi: 10.1007/s10802-009-9373-6.
Results Reference
derived

Learn more about this trial

Treatment of Childhood Social Phobia

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