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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00247754
• Other study ID #: B01-0072
• Status: Completed
• Phase: N/A
• First received: October 31, 2005
• Last updated: October 31, 2005
• Start date: November 2002
• Est. completion date: June 2005

Study information

• Verified date: October 2005
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 13 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• Cognitive Behaviour Treatment

Locations

Country	Name	City	State
Canada	University of British Columbia, Faculty of Education	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety symptoms