Social PhobiaPhase 3NCT00043537
Treatment of Childhood Social Phobia
A Phase 3 study testing Social Effectiveness Therapy for Children (SET-C) and Fluoxetine in people with Social Phobia, run by University of Central Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Phobia
- What is being tested?
- Social Effectiveness Therapy for Children (SET-C) and Fluoxetine
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Sep 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosis of social phobia
Who cannot join
- Pervasive developmental disorders (PDD)
- Schizophrenia
- Major Depression
- IQ of less than 80
- Medical conditions contraindicating use of fluoxetine
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Center for Anxiety Disorders
University of Maryland, College Park, Maryland, 20742
About this study
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.
Read the 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.
- Conditions
- Social Phobia
- Being tested
- Social Effectiveness Therapy for Children (SET-C), Fluoxetine, Pill Placebo
- Keywords
- Phobic Disorders, Mutism
- Medical subject headings
- Phobia, Social, Phobic Disorders, Mutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Effectiveness Therapy for Children (SET-C)Behavioural
FluoxetineDrug
Pill PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Social Effectiveness Therapy for Children | Experimental | Social Effectiveness Therapy for Children includes social skills training, peer generalization experiences and exposure therapy Receives: Behavioral: Social Effectiveness Therapy for Children (SET-C) |
| Fluoxetine | Experimental | Fluoxetine given in 10mg doses, up to 40 mg as tolerated Receives: Drug: Fluoxetine |
| Pill placebo | Placebo comparator | Capsules identical to fluoxetine given in "10 mg." doses up to 40 mg. Receives: Drug: Pill Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2002 (estimated)
- Study startApr 2001
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Social PhobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Deborah Beidel, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043537
- Sponsor's protocol ID
- R01MH053703
- Other IDs
- R01MH053703
- Status last verified
- Jul 2013
- First submitted
- 9 Aug 2002
- Last updated
- 1 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18030084De 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.
PubMed 21391024De 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.
PubMed 20013046
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Childhood Social Phobia
- ClinicalTrials.gov ID
- NCT00043537
- Acronym / sponsor ID
- R01MH053703
- Conditions
- Social Phobia
- Keywords
- Phobic Disorders, Mutism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2001
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 12 Aug 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Social Effectiveness Therapy for Children | Experimental | Behavioral: Social Effectiveness Therapy for Children (SET-C)Social Effectiveness Therapy for Children includes social skills training, peer generalization experiences and exposure therapy |
| Fluoxetine | Experimental | Drug: FluoxetineFluoxetine given in 10mg doses, up to 40 mg as tolerated |
| Pill placebo | Placebo comparator | Drug: Pill PlaceboCapsules identical to fluoxetine given in "10 mg." doses up to 40 mg. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosis of social phobia
Key exclusion criteria (5 listed)
- Pervasive developmental disorders (PDD)
- Schizophrenia
- Major Depression
- IQ of less than 80
- Medical conditions contraindicating use of fluoxetine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Effectiveness Therapy for Children (SET-C) | Behavioural | Social Effectiveness Therapy for Children |
| Fluoxetine | Drug | Fluoxetine |
| Pill Placebo | Drug | Pill placebo |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2013.
- Results publication: PubMed 18030084Beidel 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.
- Derived from this study: PubMed 21391024De 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.
- Derived from this study: PubMed 20013046De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Social Effectiveness Therapy for Children (SET-C) and Fluoxetine in people with Social Phobia, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00043537, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2013.