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Trial record 11 of 206 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

Bridging the Gap - Tools for Finding Health, Mental Health and Wellness Resources for University and College Students

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ClinicalTrials.gov Identifier: NCT03412461
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
David Wiljer, Centre for Addiction and Mental Health

Brief 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.


Condition or disease Intervention/treatment Phase
Adolescent Mental Health Wellness 1 Self Efficacy Stigma, Social Other: Thought Spot Other: Resource Pamphlet Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 472 participants
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)
Masking Description: To maintain partial blindness, researchers administering surveys will not be aware of the group allocation of participants. A researcher who will not be in contact with participants will conduct the randomization. Recruitment materials do not include any reference to the intervention (Thought Spot) and therefore, mitigates any potential demand characteristics among participants
Primary Purpose: Other
Official Title: Bridging the Gap - Tools for Finding Health, Mental Health and Wellness Resources for University and College Students
Actual Study Start Date : March 13, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Other: 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.
Active Comparator: 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.
Other: 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.



Primary Outcome Measures :
  1. The General Help Seeking Questionnaire (change over 6 month trial period) [ Time Frame: This scale will be administered at baseline, 3 month and 6 month mark. ]
    The General Help Seeking Questionnaire is used to measure intentions to seek help from different sources. Future help-seeking intentions are measured by listing a number of potential help sources and asking participants to indicate how likely it is that they would seek help from that source for a specified problem on a seven-point scale ranging from (1) extremely unlikely to seek help to (7) extremely likely to seek help. Higher scores indicate higher intentions for help-seeking. The GHSQ items are scored as a single scale that includes all specific help source options for the specified problem.


Secondary Outcome Measures :
  1. Actual Help Seeking Questionnaire (AHSQ) [ Time Frame: This scale will be administered at baseline, 3 month and 6 month mark. ]

    The Actual Help Seeking Questionnaire is used to measure past help seeking. Recent help-seeking behavior is determined by listing a number of potential help sources and asking whether or not help has been sought from each of the sources during a specified period of time for a specified problem. Participants provide a "yes" or "no" response for each help source option that matched those listed in the GHSQ. To provide additional descriptive information and to ensure that participants are responding in the appropriate way, participants are asked to briefly elaborate on the nature of the problem for which help was sought. Participants can also indicate that they have had a problem, but have sought help from no one.

    experiences. A higher total number of instances of help sought from either formal or informal help sources indicates a higher degree of help-seeking behaviour.


  2. Attitudes towards seeking professional psychological help (ATSPPH-SF) [ Time Frame: This scale will be administered at baseline, 3 month and 6 month mark. ]
    The Attitudes Towards Seeking Professional Psychological Help (SF) is used to measure participants process of seeking professional help.This scale measures general attitudes towards seeking professional psychological help for mental health issues. Items are rated on a 4-pointLikert-type scale (3 = Agree,0 = Disagree), where items 2,4,8,9, and 10 are reverse scored. Items are rated from 1 (disagree) to 4 (agree), with five items reversed scored. Scores are summed together with higher scores indicating more positive attitudes toward seeking professional help.

  3. Self-Stigma of Seeking Help Scale (SSOSH) [ Time Frame: This scale will be administered at baseline, 3 month and 6 month mark. ]
    The Self-Stigma of Seeking Help Scale is used to measure change in participants self-stigma of seeking psychological help. Items are rated from 1 (Strongly Disagree) to 5 (Strongly Agree) on a scale of 10 questions. Items 2, 4, 5, 7, and 9 are reverse scored. Because the self- stigma associated with seeking psychological help was hypothesized to keep people from seeking treatment, those who have sought help should have lower SSOSH scores than those who had not. Lower scores (less stigma), therefore, are better outcomes in terms of likelihood to engage in psychological help-seeking. The questions on the SSOSH are scored as a single scale. Items 2, 4, 5, 7, and 9 are reverse scored.

  4. Youth Efficacy/Empowerment Scale - Mental Health (YES-MH) [ Time Frame: This scale will be administered at baseline, 3 month and 6 month mark. ]
    The Youth Efficacy/Empowerment Scale is used to measure change in participants empowerment and efficacy when consuming mental health services. Items are rated from 1 (never or almost never) to 5 (always or almost always), with three items reversed scored. Higher scores from the sum of the subscales represents higher overall youth efficacy/empowerment with respect to mental health. The subscales can be used separately. The sum of their scores yields a score for overall youth efficacy/empowerment with respect to mental health.



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 17-29 years, inclusive.
  • 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 do not have access to a functional mobile device or computer.
  • Individuals who are experiencing active suicidality.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412461


Contacts
Contact: David Wiljer, PhD 416-340-6322 david.wiljer@uhn.ca
Contact: Alexxa Abi-Jaoude, MPH 416-535-8501 alexxa.abijaoude@camh.ca

Locations
Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: David Wiljer, PhD    4163406322    david.wiljer@uhn.ca   
Contact: Alexxa Abi-Jaoude, MPH    416-535-8501    alexxa.abijaoude@camh.ca   
Sponsors and Collaborators
Centre for Addiction and Mental Health
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: David Wiljer, PhD Centre for Addiction and Mental Health

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Wiljer, Principal Investigator, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT03412461     History of Changes
Other Study ID Numbers: 023/2017
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Wiljer, Centre for Addiction and Mental Health:
Transition-aged youth
Mental Health
Accessibility