Mental Health LiteracyNCT04645784
Long-term Effect of Online Mental Health Literacy Training
A study testing Supporting Student-Athletes Mental Wellness in people with Mental Health Literacy and Waitlist, run by Brock University at 1 site in Canada.
Trial summary
The purpose of this study is to assess the effectiveness over time of an online mental health in sport module in improving mental health literacy, stigma, and help-seeking behaviors in a sample of Brock student-athletes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mental Health Literacy, Waitlist
- What is being tested?
- Supporting Student-Athletes Mental Wellness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 2 Dec 2020to 30 Apr 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- student-athletes
Who cannot join
- non student-athletes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Long-term Effect of Online Mental Health Literacy Training in Intercollegiate Sport
The purpose of this study is to assess the effectiveness over time of an online mental health in sport module in improving mental health literacy, stigma, and help-seeking behaviors in a sample of Brock student-athletes. Student-athletes will be assigned to one of two conditions, mental health module or the waitlist condition. The mental health module will consist of completing the Supporting Student-Athletes Mental Wellness" online module for the student-athlete by the National Collegiate Athletics Association (NCAA). Participants will complete surveys at pre-intervention, post-intervention, 3-months and 6-month time points.
- Conditions
- Mental Health Literacy, Waitlist
- Being tested
- Supporting Student-Athletes Mental Wellness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supporting Student-Athletes Mental WellnessOther
The module addresses: 1) managing your own mental wellness; 2) signs and symptoms of mental health problems; 3) role of student-athletes in creating a positive team environment that is supportive of mental health care seeking; 4) the role of a student-athlete in helping teammates; 5) how to identify emergency and non-emergency mental health situations.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Receives the supporting student-athlete mental wellness module Receives: Other: Supporting Student-Athletes Mental Wellness |
| Waitlist | No intervention | Receives no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Multicomponent Mental Health Literacy Measure
Multicomponent Mental Health Literacy Measure
Measured: 72 hours pre-intervention, 72 hours post-intervention, 3-months post, 6-months post
Change in Self-Stigma
Self Stigma of Seeking Help Survey
Measured: 72 hours pre-intervention, 72 hours post-intervention, 3-months post, 6-months post
Change in Help seeking intentions
General Help-Seeking Questionnaire
Measured: 72 hours pre-intervention, 72 hours post-intervention, 3-months post, 6-months post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start2 Dec 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Why it stopped: Less participants than required
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health LiteracyStudies 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Tennant, Brock University
- Investigators
- Philip Sullivan, Principal investigator, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645784
- Sponsor's protocol ID
- REB 20-091
- Status last verified
- Feb 2022
- First submitted
- 18 Nov 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Long-term Effect of Online Mental Health Literacy Training in Intercollegiate Sport
- ClinicalTrials.gov ID
- NCT04645784
- Acronym / sponsor ID
- REB 20-091
- Conditions
- Mental Health Literacy, Waitlist
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Less participants than required
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 27 Nov 2020 (actual)
- 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.
The purpose of this study is to assess the effectiveness over time of an online mental health in sport module in improving mental health literacy, stigma, and help-seeking behaviors in a sample of Brock student-athletes. Student-athletes will be assigned to one of two conditions, mental health module or the waitlist condition. The mental health module will consist of completing the Supporting Student-Athletes Mental Wellness" online module for the student-athlete by the National Collegiate Athletics Association (NCAA). Participants will complete surveys at pre-intervention, post-intervention, 3-months and 6-month time points.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Supporting Student-Athletes Mental WellnessReceives the supporting student-athlete mental wellness module |
| Waitlist | No intervention | –Receives no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- student-athletes
Key exclusion criteria (1 listed)
- non student-athletes
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 |
|---|---|---|
| Supporting Student-Athletes Mental WellnessThe module addresses: 1) managing your own mental wellness; 2) signs and symptoms of mental health problems; 3) role of student-athletes in creating a positive team environment that is supportive of mental health care seeking; 4) the role of a student-athlete in helping teammates; 5) how to identify emergency and non-emergency mental health situations. | Other | Intervention |
Primary outcome
Change in Multicomponent Mental Health Literacy Measure
Time frame: 72 hours pre-intervention, 72 hours post-intervention, 3-months post, 6-months post
Multicomponent Mental Health Literacy Measure
Change in Self-Stigma
Time frame: 72 hours pre-intervention, 72 hours post-intervention, 3-months post, 6-months post
Self Stigma of Seeking Help Survey
Change in Help seeking intentions
Time frame: 72 hours pre-intervention, 72 hours post-intervention, 3-months post, 6-months post
General Help-Seeking Questionnaire
Results and safety
The study was stopped early (reason given: Less participants than required). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Philip Sullivan principal investigator
Brock University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supporting Student-Athletes Mental Wellness in people with Mental Health Literacy and Waitlist, run by Brock University 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: stopped early, as of the sponsor's last update on 15 Mar 2022. 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 was stopped early (reason given: Less participants than required). Results are not available in the source record.
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?
Change in Multicomponent Mental Health Literacy Measure (time frame: 72 hours pre-intervention, 72 hours post-intervention, 3-months post, 6-months post). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2022.