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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

Tracking Information
First Submitted Date  ICMJE June 9, 2014
First Posted Date  ICMJE June 23, 2014
Last Update Posted Date December 10, 2015
Study Start Date  ICMJE February 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2014)
  • Decreased use of alcohol, tobacco and other drugs [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    Questionnaire (CRAFFT)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comprehensive Program for Youth Mental Health
Official Title  ICMJE Comprehensive Program for Youth Mental Health
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Depression
  • Suicide
  • Anxiety
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Resiliency Training
  • 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.
    Interventions:
    • Behavioral: Smart, Positive, Active, Realistic X-factor thoughts (SPARX)
    • Behavioral: Breaking Free
    • Behavioral: This Way Up
    • Behavioral: Resiliency Training
  • 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.
    Interventions:
    • Behavioral: Smart, Positive, Active, Realistic X-factor thoughts (SPARX)
    • Behavioral: Breaking Free
    • Behavioral: This Way Up
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2015)
5514
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2014)
3500
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02169960
Other Study ID Numbers  ICMJE AMH-SCN-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE
  • Red Deer Public School District
  • Addiction & Mental Health Strategic Clinical Network
Investigators  ICMJE
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
PRS Account University of Alberta
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP