Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comprehensive Program for Youth Mental Health (EMPATHY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02169960
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : December 10, 2015
Sponsor:
Collaborators:
Red Deer Public School District
Addiction & Mental Health Strategic Clinical Network
Information provided by (Responsible Party):
University of Alberta

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

Condition or disease Intervention/treatment Phase
Depression Suicide Anxiety Behavioral: Smart, Positive, Active, Realistic X-factor thoughts (SPARX) Behavioral: Breaking Free Behavioral: This Way Up Behavioral: Resiliency Training Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5514 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comprehensive Program for Youth Mental Health
Study Start Date : February 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


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: 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

Behavioral: Resiliency Training
Op Volle Kracht (OVK)

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Decreased use of alcohol, tobacco and other drugs [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    Questionnaire (CRAFFT)

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169960


Locations
Layout table for location information
Canada, Alberta
Red Deer Public Schools
Red Deer, Alberta, Canada
Sponsors and Collaborators
University of Alberta
Red Deer Public School District
Addiction & Mental Health Strategic Clinical Network
Investigators
Layout table for investigator information
Principal Investigator: Peter H SIlverstone, M.D. Alberta Health Services and University of Alberta
Study Director: Victoria YM Suen, B.A. (hons) Alberta Health Services