- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00247754
VP3: Vancouver Primary Prevention Program (Anxiety Disorders Prevention in School Children)
October 31, 2005 updated by: University of British Columbia
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
281
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6T 1Z4
- University of British Columbia, Faculty of Education
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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.
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Anxiety symptoms
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lynn Miller, PhD, R.Psych., University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2002
Study Completion
June 1, 2005
Study Registration Dates
First Submitted
October 31, 2005
First Submitted That Met QC Criteria
October 31, 2005
First Posted (Estimate)
November 2, 2005
Study Record Updates
Last Update Posted (Estimate)
November 2, 2005
Last Update Submitted That Met QC Criteria
October 31, 2005
Last Verified
October 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B01-0072
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.