Comprehensive Program for Youth Mental Health (EMPATHY)

December 8, 2015 updated by: University of Alberta

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5514

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Red Deer, Alberta, Canada
        • Red Deer Public Schools

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Middle School, General
OVK Resiliency Training Program - Cognitive Behavioral Therapy designed to modify negative thoughts and feelings. This program also includes a social problem-solving component.
Behavioral: Resiliency Training
Op Volle Kracht (OVK)
NO_INTERVENTION: High School, General
No intervention - no Resiliency training, no online intervention for high school students who do not score at risk for development of mental health issues
ACTIVE_COMPARATOR: Middle School, Top 10%
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.
Behavioral: Resiliency Training
Op Volle Kracht (OVK)
Behavioral: Smart, Positive, Active, Realistic X-factor thoughts (SPARX)
Cognitive Behavioral Therapy based online intervention for depression
Behavioral: Breaking Free
Online based intervention for Drug and Alcohol Use
Behavioral: This Way Up
Cognitive Behavioral Therapy online intervention for Depression and Anxiety
ACTIVE_COMPARATOR: High School, Top 10%
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.
Behavioral: Smart, Positive, Active, Realistic X-factor thoughts (SPARX)
Cognitive Behavioral Therapy based online intervention for depression
Behavioral: Breaking Free
Online based intervention for Drug and Alcohol Use
Behavioral: This Way Up
Cognitive Behavioral Therapy online intervention for Depression and Anxiety

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease from baseline in rates of depression and suicide
Time Frame: 12 months
This will be based on scores on the Patient Health Questionnaire for Adolescents (PHQ-A) questionnaire
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decreased use of alcohol, tobacco and other drugs
Time Frame: Baseline, 3 months, 6 months, 12 months
Questionnaire (CRAFFT)
Baseline, 3 months, 6 months, 12 months
Decreased school drop-out rates
Time Frame: 12 months
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.
12 months
Decreased rates of interactions with the justice system
Time Frame: 12 months
Will be linking with a data groups' repository as well as ministries in order to determine rates of interactions with the justice system.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Red Deer Public School District
Addiction & Mental Health Strategic Clinical Network

Investigators

  • Study Director: Victoria YM Suen, B.A. (hons), Alberta Health Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

June 9, 2014

First Submitted That Met QC Criteria

June 20, 2014

First Posted (ESTIMATE)

June 23, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

December 10, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMH-SCN-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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