Phobic DisordersPhase 1/2NCT00051220
Treatment for Specific Phobias in Children
A Phase 1/2 study testing One-Session Treatment for Specific Phobias in people with Phobic Disorders and Anxiety Disorders, run by Virginia Polytechnic Institute and State University at 2 sites in 2 countries.
Trial summary
This study will compare the effectiveness of three treatments in reducing symptoms of phobia in children and adolescents. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Phobic Disorders, Anxiety Disorders
- What is being tested?
- One-Session Treatment for Specific Phobias
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2001to Sep 2006
- Phase
- Phase 1/2
- 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 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Primary diagnosis of specific phobia disorder
Who cannot join
- Mental retardation
- Developmental disabilities
- Suicide threat
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
VA Polytech. Institute and State University
Blacksburg, Virginia
About this study
Official title: One-Session Treatment for Specific Phobias in Children
This study will compare the effectiveness of three treatments in reducing symptoms of phobia in children and adolescents.
Read the detailed description
Children with specific phobias may experience academic, social, and personal distress, as well as interference in day-to-day activities. One-Session Treatment has been found a rapid and effective treatment for adults with phobic disorders. However, its utility in the treatment of childhood phobia has not been examined.
Participants are randomly assigned to 1 of 3 groups: a one-session treatment group, an education/support group, and a waitlist control group. The one-session treatment group is directly exposed to a phobia object or situation during a 3-hour treatment session. In the education/support group, children are given information about fear and phobias and are taught how to deal with them through workbook activities. Children who participate in the one-session treatment group or the education/support group are assessed 1 week post-treatment and again after 6 months. Participants with improved symptoms have a 1-year follow-up. Participants with phobias that persist at 6 months are encouraged to participate in alternative treatment. Waitlist control participants are assessed pre-treatment and 1 month post-treatment. Those who continue to have phobias at the 1-month assessment are randomly assigned to 1 of the 2 active treatments.
- Conditions
- Phobic Disorders, Anxiety Disorders
- Being tested
- One-Session Treatment for Specific Phobias
- Medical subject headings
- Phobic Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-Session Treatment for Specific PhobiasBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2003 (estimated)
- Study startOct 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.
- Other trials for Phobic DisordersStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Thomas H. Ollendick, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051220
- Sponsor's protocol ID
- R01MH059308
- Other IDs
- R01MH059308, DSIR CT-S
- Status last verified
- Jun 2013
- First submitted
- 7 Jan 2003
- Last updated
- 7 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-Session Treatment for Specific Phobias in Children
- ClinicalTrials.gov ID
- NCT00051220
- Acronym / sponsor ID
- R01MH059308
- Conditions
- Phobic Disorders, Anxiety Disorders
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2001
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 8 Jan 2003 (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 study will compare the effectiveness of three treatments in reducing symptoms of phobia in children and adolescents.
Detailed description
Children with specific phobias may experience academic, social, and personal distress, as well as interference in day-to-day activities. One-Session Treatment has been found a rapid and effective treatment for adults with phobic disorders. However, its utility in the treatment of childhood phobia has not been examined.
Participants are randomly assigned to 1 of 3 groups: a one-session treatment group, an education/support group, and a waitlist control group. The one-session treatment group is directly exposed to a phobia object or situation during a 3-hour treatment session. In the education/support group, children are given information about fear and phobias and are taught how to deal with them through workbook activities. Children who participate in the one-session treatment group or the education/support group are assessed 1 week post-treatment and again after 6 months. Participants with improved symptoms have a 1-year follow-up. Participants with phobias that persist at 6 months are encouraged to participate in alternative treatment. Waitlist control participants are assessed pre-treatment and 1 month post-treatment. Those who continue to have phobias at the 1-month assessment are randomly assigned to 1 of the 2 active treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Primary diagnosis of specific phobia disorder
Key exclusion criteria (3 listed)
- Mental retardation
- Developmental disabilities
- Suicide threat
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 |
|---|---|---|
| One-Session Treatment for Specific Phobias | Behavioural | – |
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 7 Jun 2013.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing One-Session Treatment for Specific Phobias in people with Phobic Disorders and Anxiety Disorders, run by Virginia Polytechnic Institute and State University at 2 sites in 2 countries.
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 3 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 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Sweden. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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 7 Jun 2013.