Mental DisordersNCT02561780
Impact of a Mental Health Curriculum for High School Students on Knowledge and Stigma
A study testing Curriculum and eLearning Follow-up in people with Mental Disorders and Education Curriculum, run by University of Ottawa.
Trial summary
This study examines the effectiveness of a school based mental health literacy intervention for high school students, on improving mental health knowledge and reducing stigma. Twenty-four high schools in the regional area of Ottawa, Canada were randomly assigned to either the curriculum or control condition at a two… Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Mental Disorders, Education Curriculum, Comparative Effectiveness Research
- What is being tested?
- Curriculum and eLearning Follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 534 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Sep 2013
- 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 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Students enrolled in the Healthy Living course of participating Ottawa area community high schools.
Who cannot join
- Students not enrolled in the Healthy Living course of participating Ottawa area community high schools.
- Students with an English reading and comprehension level lower than the sixth grade
About this study
Official title: Youth Mental Health Awareness Study and Early Intervention Research Project
This study examines the effectiveness of a school based mental health literacy intervention for high school students, on improving mental health knowledge and reducing stigma. Twenty-four high schools in the regional area of Ottawa, Canada were randomly assigned to either the curriculum or control condition at a two to one ratio. The educational curriculum was integrated within grade 11 and 12 Provincial "Healthy Living" courses, delivered by teachers, and replaced existing educational content on mental health.
Read the detailed description
There is limited evidence and consensus on the effectiveness of school-based mental health educational programs, and no standardization for mental health education being taught in schools. This study examines the effectiveness of a school-based mental health literacy intervention for adolescents, on knowledge and stigma. A secondary objective was to determine the generalizability and applicability of an educational resource for mental health in high schools.
- Conditions
- Mental Disorders, Education Curriculum, Comparative Effectiveness Research, Early Intervention, Adolescents
- Being tested
- Curriculum, eLearning Follow-up
- Keywords
- Mental Health Knowledge, Stigma, Mental Health Literacy
- Medical subject headings
- Mental Disorders, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurriculumBehavioural
Also called The Curriculum Guide
A mental health educational resource delivered in the classroom by trained educators
eLearning Follow-upBehavioural
Also called online follow-up learning module
An online mental health education module that students access individually
| Study group | Role | What they receive |
|---|---|---|
| Curriculum | Active comparator | The curriculum is a mental health literacy resource designed to inform high school curricula and contains six distinct modules: 1) stigma of mental illness; 2) understanding mental health and mental illness; 3) information on specific mental illnesses; 4) experiences of mental illness; 5) seeking help and finding support; and 6) the importance of positive mental health.
A research assistant trained teachers on The Curriculum Guide content in a half-day session. Teachers implemented The Curriculum Guide, which requires approximately 6 hours of classroom time, during regular instruction of the Healthy Living course. Receives: Behavioral: Curriculum |
| Curriculum +eLearning Follow-up | Active comparator | The curriculum is a mental health literacy resource designed to inform high school curricula and contains six distinct modules: 1) stigma of mental illness; 2) understanding mental health and mental illness; 3) information on specific mental illnesses; 4) experiences of mental illness; 5) seeking help and finding support; and 6) the importance of positive mental health.
A research assistant trained teachers on The Curriculum Guide content in a half-day session. Teachers implemented The Curriculum Guide, which requires approximately 6 hours of classroom time, during regular instruction of the Healthy Living course. Students are asked to complete follow-up modules online. These modules are only accessible after completion of the Healthy Living course. Receives: Behavioral: Curriculum; Behavioral: eLearning Follow-up |
| Teaching As Usual (Control) | No intervention | Schools randomized to this arm of the study received the unadulterated Healthy Living course, taught as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Report Knowledge of Mental Illness Scale
15 multiple choice questions about mental illness computed to provide a total score of mental health knowledge for each participant
Measured: Immediately following completed delivery of The Curriculum Guide
Self-Report Attitudes Towards Mental Illness Scale
A Likert scale of 8 statements about characteristics of individuals with mental illness computed to provide a total score of positive attitudes towards mental illness for each participant
Measured: Immediately following completed delivery of The Curriculum Guide
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startOct 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Milin, University of Ottawa
- Investigators
- Robert P Milin, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561780
- Sponsor's protocol ID
- 2010011
- Status last verified
- Sep 2015
- First submitted
- 18 Sep 2015
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Milin R, Kutcher S, Lewis SP, Walker S, Wei Y, Ferrill N, Armstrong MA. Impact of a Mental Health Curriculum on Knowledge and Stigma Among High School Students: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2016 May;55(5):383-391.e1. doi: 10.1016/j.jaac.2016.02.018. Epub 2016 Mar 8.
PubMed 27126852
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Youth Mental Health Awareness Study and Early Intervention Research Project
- ClinicalTrials.gov ID
- NCT02561780
- Acronym / sponsor ID
- 2010011
- Conditions
- Mental Disorders, Education Curriculum, Comparative Effectiveness Research, Early Intervention, Adolescents
- Keywords
- Mental Health Knowledge, Stigma, Mental Health Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 28 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the effectiveness of a school based mental health literacy intervention for high school students, on improving mental health knowledge and reducing stigma. Twenty-four high schools in the regional area of Ottawa, Canada were randomly assigned to either the curriculum or control condition at a two to one ratio. The educational curriculum was integrated within grade 11 and 12 Provincial "Healthy Living" courses, delivered by teachers, and replaced existing educational content on mental health.
Detailed description
There is limited evidence and consensus on the effectiveness of school-based mental health educational programs, and no standardization for mental health education being taught in schools. This study examines the effectiveness of a school-based mental health literacy intervention for adolescents, on knowledge and stigma. A secondary objective was to determine the generalizability and applicability of an educational resource for mental health in high schools.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Curriculum | Active comparator | Behavioral: CurriculumThe curriculum is a mental health literacy resource designed to inform high school curricula and contains six distinct modules: 1) stigma of mental illness; 2) understanding mental health and mental illness; 3) information on specific mental illnesses; 4) experiences of mental illness; 5) seeking help and finding support; and 6) the importance of positive mental health. A research assistant trained teachers on The Curriculum Guide content in a half-day session. Teachers implemented The Curriculum Guide, which requires approximately 6 hours of classroom time, during regular instruction of the Healthy Living course. |
| Curriculum +eLearning Follow-up | Active comparator | Behavioral: Curriculum, Behavioral: eLearning Follow-upThe curriculum is a mental health literacy resource designed to inform high school curricula and contains six distinct modules: 1) stigma of mental illness; 2) understanding mental health and mental illness; 3) information on specific mental illnesses; 4) experiences of mental illness; 5) seeking help and finding support; and 6) the importance of positive mental health. A research assistant trained teachers on The Curriculum Guide content in a half-day session. Teachers implemented The Curriculum Guide, which requires approximately 6 hours of classroom time, during regular instruction of the Healthy Living course. Students are asked to complete follow-up modules online. These modules are only accessible after completion of the Healthy Living course. |
| Teaching As Usual (Control) | No intervention | –Schools randomized to this arm of the study received the unadulterated Healthy Living course, taught as usual. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Students enrolled in the Healthy Living course of participating Ottawa area community high schools.
Key exclusion criteria (2 listed)
- Students not enrolled in the Healthy Living course of participating Ottawa area community high schools.
- Students with an English reading and comprehension level lower than the sixth grade
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurriculumAlso: The Curriculum GuideA mental health educational resource delivered in the classroom by trained educators | Behavioural | Curriculum, Curriculum +eLearning Follow-up |
| eLearning Follow-upAlso: online follow-up learning moduleAn online mental health education module that students access individually | Behavioural | Curriculum +eLearning Follow-up |
Primary outcome
Self-Report Knowledge of Mental Illness Scale
Time frame: Immediately following completed delivery of The Curriculum Guide
15 multiple choice questions about mental illness computed to provide a total score of mental health knowledge for each participant
Self-Report Attitudes Towards Mental Illness Scale
Time frame: Immediately following completed delivery of The Curriculum Guide
A Likert scale of 8 statements about characteristics of individuals with mental illness computed to provide a total score of positive attitudes towards mental illness for each participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
- Derived from this study: PubMed 27126852Milin R, Kutcher S, Lewis SP, Walker S, Wei Y, Ferrill N, Armstrong MA. Impact of a Mental Health Curriculum on Knowledge and Stigma Among High School Students: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2016 May;55(5):383-391.e1. doi: 10.1016/j.jaac.2016.02.018. Epub 2016 Mar 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert P Milin, MD principal investigator
Associate Professor
Questions about this trial
What is this clinical trial studying?
A study testing Curriculum and eLearning Follow-up in people with Mental Disorders and Education Curriculum, run by University of Ottawa.
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 2 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 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Self-Report Knowledge of Mental Illness Scale (time frame: Immediately following completed delivery of The Curriculum Guide). The study lists 2 primary outcomes in all. 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 NCT02561780, which also lists 1 linked publication.
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 28 Sep 2015.