Bridging the Gap - Tools for Finding Health, Mental Health and Wellness Resources for University and College Students
Condition: Adolescent; Mental Health Wellness 1; Self Efficacy; Stigma, Social
Study type: Interventional

Summary: 
      Background: Seventy percent of lifetime cases of mental illness emerge prior to age 24. While
      early detection and intervention can address approximately 70% of child and youth cases of
      mental health concerns, the majority of youth with mental health concerns do not receive the
      services they need.

      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: 
      This study is an innovative randomized control trial, in its testing of a youth-driven
      mHealth (mobile health) intervention for its effectiveness. The study will extend and advance
      our understanding of whether mHealth (mobile health) interventions can help bridge the health
      literacy gap, facilitate increased self-efficacy and lead to enhanced help-seeking abilities
      for the target population. This study is a two-group partially blinded pre-post randomized
      controlled study to evaluate the impact of the digital platform, Thought Spot, on
      transition-aged youths' self-efficacy in help-seeking. 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. 236 subjects will be recruited for the intervention arm and 236 subjects for the control
      arm at baseline. The intervention group participants will have access to the Thought Spot
      platform (study tool #1). The control group participants will receive a pamphlet that
      outlines mental health services and wellness services across the GTA (Greater Toronto Area)
      (study tool #2). Both groups will also have access to usual care including access to campus
      health services for mental health and wellness and web- and print- based information
      materials. Data will be collected from participants through a battery of online
      questionnaires to measure primary outcomes (changes in help-seeking intentions), help-seeking
      behaviours and help-seeking attitudes (secondary outcomes) as well as self-reported changes
      in self-stigma and self-efficacy, data on demographics and general mental health status. A
      final usabilitiy survey will be administered to participants in the intervention arm at the
      6-month mark, followed by a purposeful sample of 15-20 of these participants for qualitative
      interviews to further explore usability related to app acceptance, feasibility and
      performance. This extra step will be done after the last survey package has been administered
      and should not influence or confound results since both study arms will be receiving the
      exact same treatment and completing the exact same sets of surveys up to this point. Digital
      data from the Thought Spot platform will be used to expand on the self-report data collected
      from participants through the various scales and measures. Participants will receive a small
      compensation for completion of the study (completing all three surveys) to minimize overall
      attrition.

      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.
    

Intervention name(s): Thought Spot; Resource Pamphlet
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Students 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.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Transition-aged youth; Mental Health; Accessibility