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Comprehensive Program for Youth Mental Health (EMPATHY)

Primary Purpose

Depression, Suicide, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Smart, Positive, Active, Realistic X-factor thoughts (SPARX)
Breaking Free
This Way Up
Resiliency Training
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The intervention group will be the top 10% of all students participating in the school screening.

Exclusion Criteria:

  • Lack of consent, lack of assent, lack of the ability to read and understand the screening tools or intervention tools

Sites / Locations

  • Red Deer Public Schools

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

Active Comparator

Active Comparator

Arm Label

Middle School, General

High School, General

Middle School, Top 10%

High School, Top 10%

Arm Description

OVK Resiliency Training Program - Cognitive Behavioral Therapy designed to modify negative thoughts and feelings. This program also includes a social problem-solving component.

No intervention - no Resiliency training, no online intervention for high school students who do not score at risk for development of mental health issues

Smart, Positive, Active, Realistic X-factor thoughts (SPARX), Breaking Free, This Way Up online interventions offered to middle school students who score in the Top 10% of their grade for development of mental health issues. OVK Resiliency Training is also provided.

Smart, Positive, Active, Realistic X-factor thoughts (SPARX), Breaking Free, This Way Up online interventions offered to middle school students who score in the Top 10% of their grade for development of mental health issues.

Outcomes

Primary Outcome Measures

Decrease from baseline in rates of depression and suicide
This will be based on scores on the Patient Health Questionnaire for Adolescents (PHQ-A) questionnaire

Secondary Outcome Measures

Decreased use of alcohol, tobacco and other drugs
Questionnaire (CRAFFT)
Decreased school drop-out rates
Will be tracking the School identification numbers of the students in order to determine how many drop out prior to graduation. This will be compared with historical data from Red Deer Public Schools.
Decreased rates of interactions with the justice system
Will be linking with a data groups' repository as well as ministries in order to determine rates of interactions with the justice system.

Full Information

First Posted
June 9, 2014
Last Updated
December 8, 2015
Sponsor
University of Alberta
Collaborators
Red Deer Public School District, Addiction & Mental Health Strategic Clinical Network
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1. Study Identification

Unique Protocol Identification Number
NCT02169960
Brief Title
Comprehensive Program for Youth Mental Health
Acronym
EMPATHY
Official Title
Comprehensive Program for Youth Mental Health
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Red Deer Public School District, Addiction & Mental Health Strategic Clinical Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The majority of addiction and mental health problems seen in adults present first in youth. There is strong evidence that prevention and early identification during childhood can mitigate some of these risks. Students who screen at risk for the development of mental illness will be offered online intervention programs with personal guidance from a trained coach. In addition, lessons revolving around resiliency will be provided to all students. The objectives of this study are: Decreased rates of depression and suicide (as well as rates of suicide attempts) Decreased use of alcohol, tobacco, and other drugs, with additional downstream benefits such as reduced rates of fetal alcohol spectrum disorder (FASD) and cancer Decreased school drop-out rates Decreased rates of interactions with the justice system Decreased costs across a range of ministries (health, education, justice, human services), both for youth as well as their families who have been involved in this program

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Suicide, Anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5514 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Middle School, General
Arm Type
Active Comparator
Arm Description
OVK Resiliency Training Program - Cognitive Behavioral Therapy designed to modify negative thoughts and feelings. This program also includes a social problem-solving component.
Arm Title
High School, General
Arm Type
No Intervention
Arm Description
No intervention - no Resiliency training, no online intervention for high school students who do not score at risk for development of mental health issues
Arm Title
Middle School, Top 10%
Arm Type
Active Comparator
Arm Description
Smart, Positive, Active, Realistic X-factor thoughts (SPARX), Breaking Free, This Way Up online interventions offered to middle school students who score in the Top 10% of their grade for development of mental health issues. OVK Resiliency Training is also provided.
Arm Title
High School, Top 10%
Arm Type
Active Comparator
Arm Description
Smart, Positive, Active, Realistic X-factor thoughts (SPARX), Breaking Free, This Way Up online interventions offered to middle school students who score in the Top 10% of their grade for development of mental health issues.
Intervention Type
Behavioral
Intervention Name(s)
Smart, Positive, Active, Realistic X-factor thoughts (SPARX)
Intervention Description
Cognitive Behavioral Therapy based online intervention for depression
Intervention Type
Behavioral
Intervention Name(s)
Breaking Free
Intervention Description
Online based intervention for Drug and Alcohol Use
Intervention Type
Behavioral
Intervention Name(s)
This Way Up
Intervention Description
Cognitive Behavioral Therapy online intervention for Depression and Anxiety
Intervention Type
Behavioral
Intervention Name(s)
Resiliency Training
Intervention Description
Op Volle Kracht (OVK)
Primary Outcome Measure Information:
Title
Decrease from baseline in rates of depression and suicide
Description
This will be based on scores on the Patient Health Questionnaire for Adolescents (PHQ-A) questionnaire
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Decreased use of alcohol, tobacco and other drugs
Description
Questionnaire (CRAFFT)
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Decreased school drop-out rates
Description
Will be tracking the School identification numbers of the students in order to determine how many drop out prior to graduation. This will be compared with historical data from Red Deer Public Schools.
Time Frame
12 months
Title
Decreased rates of interactions with the justice system
Description
Will be linking with a data groups' repository as well as ministries in order to determine rates of interactions with the justice system.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The intervention group will be the top 10% of all students participating in the school screening. Exclusion Criteria: Lack of consent, lack of assent, lack of the ability to read and understand the screening tools or intervention tools
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter H SIlverstone, M.D.
Organizational Affiliation
Alberta Health Services and University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victoria YM Suen, B.A. (hons)
Organizational Affiliation
Alberta Health services
Official's Role
Study Director
Facility Information:
Facility Name
Red Deer Public Schools
City
Red Deer
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22233510
Citation
Tak YR, Van Zundert RM, Kuijpers RC, Van Vlokhoven BS, Rensink HF, Engels RC. A randomized controlled trial testing the effectiveness of a universal school-based depression prevention program 'Op Volle Kracht' in the Netherlands. BMC Public Health. 2012 Jan 10;12:21. doi: 10.1186/1471-2458-12-21.
Results Reference
background
PubMed Identifier
25974146
Citation
Silverstone PH, Bercov M, Suen VY, Allen A, Cribben I, Goodrick J, Henry S, Pryce C, Langstraat P, Rittenbach K, Chakraborty S, Engels RC, McCabe C. Initial Findings from a Novel School-Based Program, EMPATHY, Which May Help Reduce Depression and Suicidality in Youth. PLoS One. 2015 May 14;10(5):e0125527. doi: 10.1371/journal.pone.0125527. eCollection 2015.
Results Reference
derived

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Comprehensive Program for Youth Mental Health

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