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Treatment of Childhood Social Phobia

Treatment of Childhood Social Phobia

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00043537
Enrollment
139
Registered
2002-08-12
Start date
2001-04-30
Completion date
2006-09-30
Last updated
2013-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Phobia

Keywords

Phobic Disorders, Mutism

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.

Interventions

BEHAVIORALSocial Effectiveness Therapy for Children (SET-C)
DRUGFluoxetine

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Central Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 16 Years
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026