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DepressionEMPATHYNCT02169960

Comprehensive Program for Youth Mental Health

A study testing Smart, Positive, Active, Realistic X-factor thoughts (SPARX), Breaking Free and This Way Up in people with Depression and Suicide, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 11 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Depression, Suicide, Anxiety
What is being tested?
Smart, Positive, Active, Realistic X-factor thoughts (SPARX), Breaking Free and This Way Up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,514 participants
Where
1 siteCanada
Study dates
Feb 2014to Jun 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Red Deer Public Schools

    Red Deer, Alberta

Other trials in Canada

About this study

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
Being tested
Smart, Positive, Active, Realistic X-factor thoughts (SPARX), Breaking Free, This Way Up, Resiliency Training
Medical subject headings
Depression, Suicide, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smart, Positive, Active, Realistic X-factor thoughts (SPARX)Behavioural

    Cognitive Behavioral Therapy based online intervention for depression

  • Breaking FreeBehavioural

    Online based intervention for Drug and Alcohol Use

  • This Way UpBehavioural

    Cognitive Behavioral Therapy online intervention for Depression and Anxiety

  • Resiliency TrainingBehavioural

    Op Volle Kracht (OVK)

Study groups in NCT02169960
Study groupRoleWhat they receive
Middle School, GeneralActive comparatorOVK Resiliency Training Program - Cognitive Behavioral Therapy designed to modify negative thoughts and feelings. This program also includes a social problem-solving component.
Receives: Behavioral: Resiliency Training
High School, GeneralNo interventionNo 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 comparatorSmart, 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.
Receives: Behavioral: Smart, Positive, Active, Realistic X-factor thoughts (SPARX); Behavioral: Breaking Free; Behavioral: This Way Up; Behavioral: Resiliency Training
High School, Top 10%Active comparatorSmart, 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.
Receives: Behavioral: Smart, Positive, Active, Realistic X-factor thoughts (SPARX); Behavioral: Breaking Free; Behavioral: This Way Up

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (3)

  1. Decreased use of alcohol, tobacco and other drugs

    Questionnaire (CRAFFT)

    Measured: Baseline, 3 months, 6 months, 12 months

  2. 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.

    Measured: 12 months

  3. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
5,514 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02169960
Sponsor's protocol ID
AMH-SCN-02
Acronym
EMPATHY
Status last verified
Dec 2015
First submitted
9 Jun 2014
Last updated
10 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22233510

  • 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.

    PubMed 25974146

Questions about this trial

What is this clinical trial studying?

A study testing Smart, Positive, Active, Realistic X-factor thoughts (SPARX), Breaking Free and This Way Up in people with Depression and Suicide, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease from baseline in rates of depression and suicide (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02169960, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015.

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