VP3: Vancouver primary prevention project (anxiety disorders prevention in school children)
| ISRCTN | ISRCTN72046738 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72046738 |
| ClinicalTrials.gov (NCT) | NCT00247754 |
| Protocol serial number | MCT-53658 |
| Sponsor | University of British Columbia (Canada) |
| Funder | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-53658) |
- Submission date
- 24/02/2006
- Registration date
- 24/02/2006
- Last edited
- 07/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Lynn Miller
Scientific
Scientific
University of British Columbia
Faculty of Education
2125 Main Mall
Vancouver
V6T 1Z4
Canada
| Phone | +1 604 822 8539 |
|---|---|
| lynn.miller@ubc.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | VP3: Vancouver primary prevention project (anxiety disorders prevention in school children) |
| Study acronym | VP3 |
| Study objectives | 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(s) | Behavioural Research Ethics Board, University of British Columbia, Vancouver, British Columbia, Canada (12 November, 2004). |
| Health condition(s) or problem(s) studied | Anxiety disorders |
| Intervention | Cognitive behavior therapy (CBT) or an attention control procedure (storytelling) Trial details received: 12 Sept 2005 |
| Intervention type | Other |
| Primary outcome measure(s) |
Anxiety symptoms |
| Key secondary outcome measure(s) |
1. Extension to other school systems within BC (outside Vancouver) |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 11 Years |
| Sex | All |
| Target sample size at registration | 281 |
| Total final enrolment | 1039 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/04/2002 |
| Date of final enrolment | 30/06/2005 |
Locations
Countries of recruitment
- Canada
Study participating centre
University of British Columbia
Vancouver
V6T 1Z4
Canada
V6T 1Z4
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2014 | 07/01/2021 | Yes | No |
Editorial Notes
07/01/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
28/01/2019: No publications found, verifying results with the principal investigator
