Comprehensive Program for Youth Mental Health

Depression Clinical Trial

— EMPATHY  

Official title:

Comprehensive Program for Youth Mental Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169960
• Other study ID #: AMH-SCN-02
• Status: Completed
• Phase: N/A
• First received: June 9, 2014
• Last updated: December 8, 2015
• Start date: February 2014
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5514
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 18 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety
• Depression
• Suicide

Intervention

Behavioral:
• Smart, Positive, Active, Realistic X-factor thoughts (SPARX)
Cognitive Behavioral Therapy based online intervention for depression
• Breaking Free
Online based intervention for Drug and Alcohol Use
• This Way Up
Cognitive Behavioral Therapy online intervention for Depression and Anxiety
• Resiliency Training
Op Volle Kracht (OVK)

Locations

Country	Name	City	State
Canada	Red Deer Public Schools	Red Deer	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Alberta	Addiction and Mental Health Strategic Clinical Network, Red Deer Public School District

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months	Yes
Secondary	Decreased use of alcohol, tobacco and other drugs	Questionnaire (CRAFFT)	Baseline, 3 months, 6 months, 12 months	No
Secondary	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.	12 months	No
Secondary	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.	12 months	No