Treatment of Childhood Social Phobia

NCT ID: NCT00043537

Last Updated: 2013-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2006-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Social Phobia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Social Effectiveness Therapy for Children

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

Group Type EXPERIMENTAL

Social Effectiveness Therapy for Children (SET-C)

Intervention Type BEHAVIORAL

Fluoxetine

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

Group Type EXPERIMENTAL

Fluoxetine

Intervention Type DRUG

Pill placebo

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

Group Type PLACEBO_COMPARATOR

Pill Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Social Effectiveness Therapy for Children (SET-C)

Intervention Type BEHAVIORAL

Fluoxetine

Intervention Type DRUG

Pill Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Central Florida

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Deborah Beidel

Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maryland Center for Anxiety Disorders

University of Maryland, College Park, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 18030084 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21391024 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20013046 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01MH053703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01MH053703

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Treatment of Social Phobia
NCT00000370 COMPLETED NA
Treatment for Specific Phobias in Children
NCT00051220 COMPLETED PHASE1/PHASE2
Glucocorticoid Treatment for Social Phobia
NCT01574014 TERMINATED PHASE2