NCT02561780

Brief 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 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
534

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

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

October 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 28, 2015

Completed
Last Updated

September 28, 2015

Status Verified

September 1, 2015

Enrollment Period

1.9 years

First QC Date

September 18, 2015

Last Update Submit

September 24, 2015

Conditions

Keywords

Mental Health KnowledgeStigmaMental Health Literacy

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    Immediately following completed delivery of The Curriculum Guide

Study Arms (3)

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.

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.

Behavioral: CurriculumBehavioral: 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.

Interventions

CurriculumBEHAVIORAL

A mental health educational resource delivered in the classroom by trained educators

Also known as: The Curriculum Guide
CurriculumCurriculum +eLearning Follow-up

An online mental health education module that students access individually

Also known as: online follow-up learning module
Curriculum +eLearning Follow-up

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Students enrolled in the Healthy Living course of participating Ottawa area community high schools.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Mental DisordersSocial Stigma

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Robert P Milin, MD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Psychiatry

Study Record Dates

First Submitted

September 18, 2015

First Posted

September 28, 2015

Study Start

October 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

September 28, 2015

Record last verified: 2015-09