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VP3: Vancouver Primary Prevention Program (Anxiety Disorders Prevention in School Children)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00247754
Recruitment Status : Completed
First Posted : November 2, 2005
Last Update Posted : November 2, 2005
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University of British Columbia

Tracking Information
First Submitted Date  ICMJE October 31, 2005
First Posted Date  ICMJE November 2, 2005
Last Update Posted Date November 2, 2005
Study Start Date  ICMJE November 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2005)
Anxiety symptoms
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VP3: Vancouver Primary Prevention Program (Anxiety Disorders Prevention in School Children)
Official Title  ICMJE VP3: Vancouver Primary Prevention Program (Anxiety Disorders Prevention in School Children)
Brief 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. 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
  4. To evaluate a new measure of teacher-rated anxiety disorder symptoms in children.

Hypothesis:

  1. 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.
  2. Children who have parental involvement will post stronger and more enduring treatment gains.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Condition  ICMJE Anxiety
Intervention  ICMJE Behavioral: Cognitive Behaviour Treatment
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 31, 2005)
281
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

Children enrolled in school between the ages of 7 and 13 who display anxiety symptoms.

  1. 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.
  2. Fluency in English.
  3. Parent willingness to sign consent form and to complete required assessments.
  4. Student willingness to participate (child assent) in 10-week affective education program and completion of required assessments.

Exclusion Criteria:

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00247754
Other Study ID Numbers  ICMJE B01-0072
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Lynn Miller, PhD, R.Psych. University of British Columbia
PRS Account University of British Columbia
Verification Date October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP