Condition category
Mental and Behavioural Disorders
Date applied
24/02/2006
Date assigned
24/02/2006
Last edited
18/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lynn Miller

ORCID ID

Contact details

University of British Columbia
Faculty of Education
2125 Main Mall
Vancouver
V6T 1Z4
Canada
+1 604 822 8539
lynn.miller@ubc.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00247754

Protocol/serial number

MCT-53658

Study information

Scientific title

Acronym

VP3

Study hypothesis

1. A cognitive behavior therapy (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

Ethics approval

Behavioural Research Ethics Board, University of British Columbia, Vancouver, British Columbia, Canada (12 November, 2004).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Anxiety disorders

Intervention

Cognitive behavior therapy (CBT) or an attention control procedure (storytelling)

Trial details received: 12 Sept 2005

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Anxiety symptoms

Secondary outcome measures

1. Extension to other school systems within BC (outside Vancouver)
2. Modification of protocol to minority populations/foreign language
3. Upward and downward modification (age range) of protocol

Overall trial start date

01/04/2002

Overall trial end date

30/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Anxiety disorder symptoms (identified by a score of 56 or higher on the Multidimensional Anxiety Scale for Children [MASC]; and teacher report, and/or parent recommendation) as the primary presenting problem
2. Aged 5 - 11 years old, either sex
3. An enrolled child must have at least 2 of these criteria:
a. Fluency in English
b. Parent willingness to sign consent form and to complete required assessments
c. Student willingness to participate (child assent) in 10-week affective education program and completion of required assessments

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

281

Participant exclusion criteria

1. Any condition which prevents the subject from participating in 10 consecutive weeks of involvement in the group
2. Special education services provided (e.g. substantial learning disabled, enrollment in other special needs program or receiving private therapeutic services)
3. Organic mental disorder or mental retardation
4. Commencement of psychotropic medication within the past 3 months. Currently medicated children will be accepted in to the study providing they (and their treating physicians) agree to keep their doses constant throughout the course of the study.

Recruitment start date

01/04/2002

Recruitment end date

30/06/2005

Locations

Countries of recruitment

Canada

Trial participating centre

University of British Columbia
Vancouver
V6T 1Z4
Canada

Sponsor information

Organisation

University of British Columbia (Canada)

Sponsor details

2075 Wesbrook Mall
Vancouver
V6T 1Z1
Canada

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-53658)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes