AnxietyNCT00247754
VP3: Vancouver Primary Prevention Program (Anxiety Disorders Prevention in School Children)
A study testing Cognitive Behaviour Treatment in people with Anxiety, run by University of British Columbia at 1 site in Canada.
Trial summary
Objective: 1. To evaluate the efficacy of a school-based cognitive behavior therapy (CBT) program in reducing anxiety disorder symptoms in at-risk public school children. 2. To determine whether parent education and involvement improves outcome in anxious children treated with CBT. 3. Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Cognitive Behaviour Treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 281 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2002to Jun 2005
- Phase
- Interventional
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children enrolled in school between the ages of 7 and 13 who display anxiety symptoms.
- Anxiety disorder symptoms (identified by a score of 56 or higher on the MASC; and teacher report, and /or parent recommendation) as the primary presenting problem. An enrolled child must have at least 2 of these criterions.
- Fluency in English.
- Parent willingness to sign consent form and to complete required assessments.
- Student willingness to participate (child assent) in 10-week affective education program and completion of required assessments.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia, Faculty of Education
Vancouver, British Columbia, V6T 1Z4
About this study
Objective:
- To evaluate the efficacy of a school-based cognitive behavior therapy (CBT) program in reducing anxiety disorder symptoms in at-risk public school children.
- To determine whether parent education and involvement improves outcome in anxious children treated with CBT.
- To determine the ability of school personnel in a) recognizing classroom behaviors as anxiety disordered after targeting training of observable child behaviors e.g., avoidance, over-worry, etc.), and b) delivering a cognitive behavior intervention and
- To evaluate a new measure of teacher-rated anxiety disorder symptoms in children.
Read more
Hypothesis:
- A CBT oriented intervention as delivered by school personnel will be superior to an attention control procedure in reducing anxiety symptoms in at-risk children.
- Children who have parental involvement will post stronger and more enduring treatment gains.
- Conditions
- Anxiety
- Being tested
- Cognitive Behaviour Treatment
- Keywords
- Anxiety, Therapy, Behaviour
- Medical subject headings
- Anxiety Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behaviour TreatmentBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2005 (estimated)
- Study startNov 2002
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 281 participants
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Lynn Miller, PhD, R.Psych., Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247754
- Sponsor's protocol ID
- B01-0072
- Status last verified
- Oct 2005
- First submitted
- 31 Oct 2005
- Last updated
- 2 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VP3: Vancouver Primary Prevention Program (Anxiety Disorders Prevention in School Children)
- ClinicalTrials.gov ID
- NCT00247754
- Acronym / sponsor ID
- B01-0072
- Conditions
- Anxiety
- Keywords
- Anxiety, Therapy, Behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Nov 2002
- Study completion
- Jun 2005
- First posted
- 2 Nov 2005 (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.
Objective:
- To evaluate the efficacy of a school-based cognitive behavior therapy (CBT) program in reducing anxiety disorder symptoms in at-risk public school children.
- To determine whether parent education and involvement improves outcome in anxious children treated with CBT.
- To determine the ability of school personnel in a) recognizing classroom behaviors as anxiety disordered after targeting training of observable child behaviors e.g., avoidance, over-worry, etc.), and b) delivering a cognitive behavior intervention and
- To evaluate a new measure of teacher-rated anxiety disorder symptoms in children.
Hypothesis:
- A CBT oriented intervention as delivered by school personnel will be superior to an attention control procedure in reducing anxiety symptoms in at-risk children.
- Children who have parental involvement will post stronger and more enduring treatment gains.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children enrolled in school between the ages of 7 and 13 who display anxiety symptoms.
- Anxiety disorder symptoms (identified by a score of 56 or higher on the MASC; and teacher report, and /or parent recommendation) as the primary presenting problem. An enrolled child must have at least 2 of these criterions.
- Fluency in English.
- Parent willingness to sign consent form and to complete required assessments.
- Student willingness to participate (child assent) in 10-week affective education program and completion of required assessments.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cognitive Behaviour Treatment | Behavioural | – |
Primary outcome
Anxiety symptoms
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 2 Nov 2005.
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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.
Lynn Miller, PhD, R.Psych. principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behaviour Treatment in people with Anxiety, run by University of British Columbia at 1 site in Canada.
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 5 inclusion and 0 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 2 Nov 2005. 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 Canada. 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.
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.
What does the primary outcome measure?
Anxiety symptoms. It is what the study was designed to measure, not a finding.
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 2 Nov 2005.