Treatment of Childhood Social Phobia

• Sponsor: University of Central Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT00043537
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 139
• Location: 1
• Arms: 3
• Duration (Months): 65
• Patients Per Site Per Month: 2.1

Study Details

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.

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.

Study Design

• Study Type: Interventional
• 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: Apr 1, 2001
• Actual Primary Completion Date: Sep 1, 2006
• Actual Study Completion Date: Sep 1, 2006

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 16 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Deborah Beidel, Professor of Psychology, University of Central Florida
• ClinicalTrials.gov Identifier: NCT00043537
• Other Study ID Numbers: R01MH053703; R01MH053703
• First Posted: Aug 12, 2002
• Last Update Posted: Aug 1, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by Deborah Beidel, Professor of Psychology, University of Central Florida: Phobic Disorders; Mutism
• Additional relevant MeSH terms: Phobic Disorders; Phobia, Social; Fluoxetine

Study Results

No Results Posted as of Aug 1, 2013