NCT02169960

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,514

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

December 10, 2015

Status Verified

December 1, 2015

Enrollment Period

1.3 years

First QC Date

June 9, 2014

Last Update Submit

December 8, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Decreased use of alcohol, tobacco and other drugs

    Baseline, 3 months, 6 months, 12 months

  • Decreased school drop-out rates

    12 months

  • Decreased rates of interactions with the justice system

    12 months

Study Arms (4)

Middle School, General

ACTIVE COMPARATOR

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

High School, General

NO INTERVENTION

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

Middle School, Top 10%

ACTIVE COMPARATOR

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)Behavioral: Breaking FreeBehavioral: This Way UpBehavioral: Resiliency Training

High School, Top 10%

ACTIVE COMPARATOR

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)Behavioral: Breaking FreeBehavioral: This Way Up

Interventions

Cognitive Behavioral Therapy based online intervention for depression

High School, Top 10%Middle School, Top 10%
Breaking FreeBEHAVIORAL

Online based intervention for Drug and Alcohol Use

High School, Top 10%Middle School, Top 10%
This Way UpBEHAVIORAL

Cognitive Behavioral Therapy online intervention for Depression and Anxiety

High School, Top 10%Middle School, Top 10%

Op Volle Kracht (OVK)

Middle School, GeneralMiddle School, Top 10%

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Red Deer Public Schools

Red Deer, Alberta, Canada

Location

Related Publications (2)

  • 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.

    PMID: 22233510BACKGROUND
  • 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.

MeSH Terms

Conditions

DepressionSuicideAnxiety Disorders

Interventions

Gene ExpressionExercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSelf-Injurious BehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Genetic PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Peter H SIlverstone, M.D.

    Alberta Health Services and University of Alberta

    PRINCIPAL INVESTIGATOR
  • Victoria YM Suen, B.A. (hons)

    Alberta Health services

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2014

First Posted

June 23, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

December 10, 2015

Record last verified: 2015-12

Locations