Bridging the Gap - Tools for Finding Health, Mental Health and Wellness Resources for University and College Students
NCT ID: NCT03412461
Last Updated: 2019-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
481 participants
INTERVENTIONAL
2018-03-13
2019-06-30
Brief Summary
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Objective: This project will evaluate the impact of Thought Spot upon intentions and self-efficacy in help-seeking for mental health concerns among transition aged youth (youth aged 17-29) enrolled full-time or part-time at a college or university in the Greater Toronto Area (GTA), compared with a control group (who receive usual care; resource pamphlet).
Methods: A two-group partially blinded pre-post randomized controlled study will be done to evaluate the impact of the digital platform, Thought Spot, on transition-aged youths' intentions to help-seek. Measurements will be taken over a 6 month period: baseline, 3 months, and 6 months. 472 participants who are enrolled part-time or full-time at one of 3 participating post-secondary institutions (George Brown College, Ryerson University, University of Toronto) who are interested in maintaining or managing their mental health will be recruited and randomized to the intervention arm or the control arm. The intervention group participants will have access to the Thought Spot platform. The control group participants will receive a pamphlet that outlines mental health services and wellness services across the GTA. Both groups will also have access to usual care.
Results: The investigators are testing the hypothesis that 1) transition-aged youth who receive the intervention will show a greater improvement in intentions and self-efficacy in help-seeking for mental health concerns than those who are allocated to the control group; and 2) participants in the intervention arm will also show greater improvements in health literacy, including awareness of available services and supports, increased self-efficacy in managing their mental health concerns, and a reduction in mental health stigma, compared to the control arm.
Detailed Description
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Objectives Primary objective: To evaluate the impact of Thought Spot upon intentions in help-seeking for mental health concerns among transition aged youth (youth aged 16-29) enrolled full-time or part-time at a college or university in the GTA, compared with a control group (who receive usual care; resource pamphlet).
Secondary objective: To examine whether participants in the intervention arm will show greater improvements in health literacy, including awareness of available services and supports, increased self-efficacy in managing their mental health concerns, and a reduction in mental health stigma, compared to the control arm.
Data Analysis Statistical Analyses All analyses will be carried out using SAS System 9.4 for Windows. Statistical tests will be 2 sided, with confidence levels of 0.05. Prior to testing, a series of univariate analyses will be carried out to ensure that model assumptions are met. To address the primary study hypothesis, a mixed-effect model will be used to account for the longitudinal nature of the data, and for attrition. Missing values will be treated with maximum likelihood estimation in SAS PROC MIXED, which uses all available information in the data. Intention-to-treat analysis will be used; all patients will be analyzed as they were originally allocated after randomization. As a sensitivity analysis, the final model will be fitted only with subjects for whom there is complete data. Formal help-seeking score will be the dependent variable, with study groups (intervention and control) and time points as predictors, and relevant socio-demographics collected at baseline as covariates to control for possible confounding.
The interaction between study group and time will be included in the model, and linear contrasts will be used to compare the groups, specifically regarding the change from baseline to the final time point. Similar models will be used to address the exploratory hypotheses, which examine different scales and trends, on the effect of the intervention over time. Bonferroni adjustment will be used to control the Type I error rate if multiple comparisons are desired. Generalized estimating equations will be used for the Actual Help Seeking Questionnaire (AHSQ), since this scale is binary.
Other Analyses A sex- and gender-based analysis will be completed when analyzing data for Phases 1 and 2. An economic evaluation of the Thought Spot intervention compared to usual care will also be explored to determine the potential cost-effectiveness and financial implications of sustainable and widespread use of Thought Spot throughout Canadian postsecondary campuses. The evaluation will be conducted from the perspective of future potential Thought Spot funders (eg, other Canadian postsecondary institutions). The primary outcome to be assessed will be the change in helping-seeking intentions among the target population
A cost-effectiveness analysis will be conducted to compare the cost and outcome of the intervention arm against usual care. The main output will be an incremental net benefit of the intervention compared to usual care \[39\] and an incremental cost for one point improvement in the General Help Seeking Questionnaire (GHSQ) in a form of an incremental cost-effectiveness ratio. The investigators will characterize the uncertainty of the findings using 95% confidence interval and a cost-effectiveness acceptability curve.
Digital data collected from the Thought Spot app will be collected and analyzed to expand on the self-report data collected from participants through the various scales and measures. Usage metrics outlining the intensity of use, usage of content, and methods of accessing app data will be calculated and analyzed. Simple descriptive statistics will also be used to report the time spent on specific app features; number of times the app is used in a day; what times in the day features are being used; and number of added spots, thoughts, and reviews. We will also conduct a high-level text analysis of the added reviews of services. This has the potential to inform a scoping review on what transition aged youth what from services. Data collected from reviews can provide the researchers with a clearer idea of what students and youth want from mental health and wellness services.
Usefulness, satisfaction, ease of use, acceptance, feasibility and performance will be analyzed through the end-of-study usability survey. Results will be analyzed using means and standard deviations of all respondents for each category of the questionnaire. The proportions of participants reporting high, medium, or low levels of satisfaction will also be calculated. The open-ended survey questions will be analyzed thematically. The findings may be correlated with the other study surveys and digital data to explore the possible influence of usage, acceptance and perceived functioning of the app upon help-seeking behaviours and help-seeking attitudes of participants.
Qualitative analysis will be conducted for the end-of-study qualitative interviews. All interviews will be audio recorded, transcribed verbatim and uploaded to NVivo. The research team will each read through data for emerging themes to develop a coding scheme. When complete, RA will code transcripts to identify major themes. We will use the thematic analysis process to review the transcribed interviews, generate codes, develop themes and finally present the findings in a final report.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Thought Spot Application
Participants randomly assigned to the experimental arm will have access to the Thought Spot application. The Thought Spot application is a mobile app and website. This digital platform was designed and produced in partnership with transition aged youth in post-secondary education. The platform maps out wellness and mental health services across the Greater Toronto Area. This group will continue to have access to usual care.
Thought Spot
Thought Spot is a mobile app and website. This digital platform was designed and produced in partnership with transition aged youth in post-secondary education. The platform maps out wellness and mental health services across the Greater Toronto Area.
Resource pamphlet
Participants randomly assigned to the active comparator will receive a pamphlet that outlines mental health services and wellness services across the Greater Toronto Area. This group will continue to have access to usual care.
Resource Pamphlet
The resource pamphlet that participants will be given will include information on the mental health and wellness services available at their respective post-secondary institution.
Interventions
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Thought Spot
Thought Spot is a mobile app and website. This digital platform was designed and produced in partnership with transition aged youth in post-secondary education. The platform maps out wellness and mental health services across the Greater Toronto Area.
Resource Pamphlet
The resource pamphlet that participants will be given will include information on the mental health and wellness services available at their respective post-secondary institution.
Eligibility Criteria
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Inclusion Criteria
* Be enrolled in full-time or part-time studies at one of the participating postsecondary institutions: University of Toronto (St. George and Scarborough campuses), Ryerson University, and George Brown College (all campuses).
* All participants must have functional competency in English.
* Participants must have access to digital devices (smartphone or desktop) compatible with the Thought Spot digital platform.
Exclusion Criteria
* Individuals who are experiencing active suicidality.
17 Years
29 Years
ALL
Yes
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Centre for Addiction and Mental Health
OTHER
Responsible Party
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David Wiljer
Principal Investigator
Principal Investigators
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David Wiljer, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre for Addiction and Mental Health
Locations
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Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Countries
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References
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Wong HW, Lo B, Shi J, Hollenberg E, Abi-Jaoude A, Johnson A, Chaim G, Cleverley K, Henderson J, Levinson A, Robb J, Voineskos A, Wiljer D. Postsecondary Student Engagement With a Mental Health App and Online Platform (Thought Spot): Qualitative Study of User Experience. JMIR Ment Health. 2021 Apr 2;8(4):e23447. doi: 10.2196/23447.
Wiljer D, Shi J, Lo B, Sanches M, Hollenberg E, Johnson A, Abi-Jaoude A, Chaim G, Cleverley K, Henderson J, Isaranuwatchai W, Levinson A, Robb J, Wong HW, Voineskos A. Effects of a Mobile and Web App (Thought Spot) on Mental Health Help-Seeking Among College and University Students: Randomized Controlled Trial. J Med Internet Res. 2020 Oct 30;22(10):e20790. doi: 10.2196/20790.
Kaur A, Isaranuwatchai W, Jaffer A, Ferguson G, Abi-Jaoude A, Johnson A, Hollenberg E, Wiljer D. A Web- and Mobile-Based Map of Mental Health Resources for Postsecondary Students (Thought Spot): Protocol for an Economic Evaluation. JMIR Res Protoc. 2018 Mar 29;7(3):e83. doi: 10.2196/resprot.9478.
Related Links
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Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital
Other Identifiers
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023/2017
Identifier Type: -
Identifier Source: org_study_id