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| ID | Type | Description | Link |
|---|---|---|---|
| 1R41MH126795-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Massachusetts, Boston | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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The goal of this clinical trial is to test the acceptability, feasibility, and efficacy of MentorPRO, a novel application that connects mentors and mentees, among incoming college first-year students in a public university. The main questions it aims to answer are:
Participants in the MentorPRO group will:
All participants (regardless of group assignment) will:
Every student in the identified program this summer (and meets the study eligibility criteria) will be eligible to participate in the study. Students who opt into participation in research activities will complete two brief surveys. Students in the intervention condition will use MentorPRO, which is a novel application and web platform for mentoring programs that allows students to set goals, track their challenges, and find just-in time resources, while connecting to a mentor for personalized support and progress monitoring. All students in in the program will be matched with a peer mentor. Students will be assigned to mentoring using MentorPRO (intervention condition) or as-usual (control condition) based on the timing of their courses; students in the morning courses and virtual courses of the summer program will use MentorPRO. All students involved in the summer program will be involved in one week of orientation, six weeks of academic programming and peer mentoring (June 12th-July 21st), meeting four days per week during the summer prior to mentees' first year in college, as well as two weeks of post-program peer mentoring (total trial of nine weeks).
At the beginning of their membership with the program, all students and mentors will be invited to participate in additional research activities. Recruitment invitations will be in postcard format from Dr. Jean Rhodes or from program staff, explaining what the study is about, what is involved for participants, what the eligibility criteria is, and a link to a Qualtrics form. The Qualtrics link will have (in order): an informed consent, an eligibility screener, and if eligible, and the pre-intervention survey (Time 1; T1). Program leaders will also promote the research project during program time, in which staff will use the same language provided in the recruitment email and flier. Students will also have time to ask questions, and any questions in which program staff cannot answer will be escalated to the research team. Individuals will also be provided the contact information of the study Principal Investigator (Dr. Jean Rhodes) in the consent form so that they can ask any questions before consenting, if relevant.
Student mentees: All interested participants will let us know their age (to determine whether they complete an informed consent or their parent/guardian completes the informed consent), and then will read and sign an informed consent, after having time to ask questions to program staff and the research team. Then, they will complete an eligibility screener, and if eligible will complete the rest of the baseline survey. Interested and eligible participants will then be prompted to take the pre-intervention survey after consenting to the study (T1). All students consenting to participate will be assigned to a peer mentor in the program. Each peer mentor will be assigned to provide mentoring as usual (without MentorPRO) or provide mentoring via MentorPRO. Students will complete the summer course for 6 weeks following a week of orientation, and will receive peer mentoring during that time. For two weeks after the course, students will be able to contact their peer mentor with questions. At the end of the 9-week trial, students will receive a final survey (T2). The eligibility screener, informed consent, and the surveys will be administered via a Qualtrics link. At the conclusion of their participation, all participants will receive a debriefing statement explaining the study and where to find additional resources if needed.
Intervention condition: In addition to the training in program policies and relationship building provided to program peer mentors, mentors in the MentorHub UMB group will undergo training designed by the research team. Mentors will complete a brief (30-min) online videos and orientation to the MentorHub UMB technology, followed by a 30-min interactive online course on providing supportive accountability, through MentorHub UMB Academy which includes "knowledge checks" to ensure mentors are engaged and understanding the material and tracks progress to ensure course completion. Additional courses will be available to mentors through the academy, including a course on mentoring ethics. Following the online training, groups of mentors will engage in a live web-conference (zoom) session with at least one staff member from UMB and at least one member of the research team, who will use motivational interviewing techniques to ensure mentor buy-in and engagement and review content from the online training modules with mentors. Finally, mentees will be given access to an online orientation to MentorHub UMB, which walks them through instructions about how to download and use the app. All study participants (mentors and student mentees) will have access to tech support within 24 hours from Academic Web Pages for any questions or issues that arise.
Mentors in the intervention condition may recommend students to use a third-party mental health app (Healthy Minds Program; HMP) if needed and provide supportive accountability (i.e., encouragement, nudges, etc) to promote consistent active engagement with HMP. Data on students' engagement with HMP will be provided at the end of the trial from the Healthy Minds team (exported from Amazon Web Services by the research team). Mentors will be encouraged provide weekly supportive accountability to students using Healthy Minds.
Mentors: At the end of the summer program, mentors will be recruited to complete a survey. Interested mentors will fill out an eligibility screener, and, if eligible, an informed consent form and brief demographics survey (all through Qualtrics), and survey with asking about their experiences as a mentor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MentorPRO | Experimental | Participants assigned to use MentorPRO |
|
| Control | No Intervention | Participants in mentoring program as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MentorPRO | Behavioral | MentorPRO is a novel application and web platform for mentoring programs that allows students to set goals, track their challenges, and find just-in time resources, while connecting to a mentor for personalized support and progress monitoring. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Depression Symptoms | Patient Health Questionnaire - 9 (PHQ-9): Depression symptoms over the last two weeks, minus item 9 (suicidal ideation) Scores range from 0 (no depression symptoms) to 24 (high/extreme depression symptoms). | 9 weeks after program start |
| Self-reported Anxiety Symptoms | General Anxiety Disorder - 7 (GAD-7): Anxiety symptoms over the last two weeks Scores range from 0 (no anxiety symptoms) to 21 (extreme/severe anxiety symptoms) | 9 weeks after program start |
| Life Satisfaction | Single item of current life satisfaction: In general, how satisfied are you with your life? Responses ranging from 1 (very satisfied) to 4 (very dissatisfied) | 9 weeks after program start |
| Measure | Description | Time Frame |
|---|---|---|
| Academic Self-efficacy | Single item of feelings of academic self-efficacy: I am confident that I will be a successful student at UMass Boston. Scores range from strongly disagree (1) to strongly agree (5) Greater scores reflect greater perceived academic self-efficacy | 9 weeks after program start |
| Cognitive Load |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean E Rhodes, PhD | University of Massachusetts, Boston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Boston | Boston | Massachusetts | 02125 | United States |
There is no current plan to share individual participant data.
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All participants were assigned to their conditions at enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | MentorPRO | Participants assigned to use MentorPRO MentorPRO: MentorPRO is a novel application and web platform for mentoring programs that allows students to set goals, track their challenges, and find just-in time resources, while connecting to a mentor for personalized support and progress monitoring. |
| FG001 | Control | Participants in mentoring program as usual |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MentorPRO | Participants assigned to use MentorPRO MentorPRO: MentorPRO is a novel application and web platform for mentoring programs that allows students to set goals, track their challenges, and find just-in time resources, while connecting to a mentor for personalized support and progress monitoring. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Self-reported Depression Symptoms | Patient Health Questionnaire - 9 (PHQ-9): Depression symptoms over the last two weeks, minus item 9 (suicidal ideation) Scores range from 0 (no depression symptoms) to 24 (high/extreme depression symptoms). | Some participants opted to skip this measure | Posted | Mean | Standard Deviation | score on a scale | 9 weeks after program start |
|
Two months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MentorPRO | Participants assigned to use MentorPRO MentorPRO: MentorPRO is a novel application and web platform for mentoring programs that allows students to set goals, track their challenges, and find just-in time resources, while connecting to a mentor for personalized support and progress monitoring. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jean Rhodes | University of Massachusetts Boston | (617) 620-9147 | jean.rhodes@umb.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 2, 2023 | Oct 10, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 2, 2023 | Oct 11, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 23, 2023 | Sep 18, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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Participants assigned based on the timing of their courses in the summer program
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Participants will know which condition they are assigned (mentors will know if they are using MentorPRO; students will know if they are using MentorPRO). Researchers will also know participant group allocation.
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Single item assessing cognitive load of finding resources on campus: It can be exhausting to find the information and resources I need to succeed. Scores range from strongly disagree (1) to strongly agree (5) Greater scores reflect greater perceived exhaustion when finding needed resources |
| 9 weeks after program start |
| Sense of Belonging to the University Community | Single item assessing feelings of sense of belonging: I feel part of the UMass Boston community. Scores range from strongly disagree (1) to strongly agree (5) Greater scores reflect greater sense of belonging to the university community | 9 weeks after program start |
| Control |
Participants in mentoring program as usual |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Although all participants reported that they were at least 18-years-old, one participant did not report exact age. | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Self-reported depression symptoms | Patient Health Questionnaire - 9 (PHQ-9): Depression symptoms over the last two weeks, minus item 9 (suicidal ideation) Scores range from 0 (no depression symptoms) to 24 (high/extreme depression symptoms). | Mean | Standard Deviation | units on a scale |
|
| Self-reported anxiety symptoms | General Anxiety Disorder - 7 (GAD-7): Anxiety symptoms over the last two weeks Scores range from 0 (no anxiety symptoms) to 21 (extreme/severe anxiety symptoms) | Mean | Standard Deviation | units on a scale |
|
| Academic self-efficacy | Single item of feelings of academic self-efficacy: I am confident that I will be a successful student at UMass Boston. Scores range from strongly disagree (1) to strongly agree (5) Greater scores reflect greater perceived academic self-efficacy | One participant preferred not to respond to this question | Mean | Standard Deviation | units on a scale |
|
| Perceived cognitive load | Single item assessing cognitive load of finding resources on campus: It can be exhausting to find the information and resources I need to succeed. Scores range from strongly disagree (1) to strongly agree (5) Greater scores reflect greater perceived exhaustion when finding needed resources | Mean | Standard Deviation | units on a scale |
|
| Life satisfaction | Single item of current life satisfaction: In general, how satisfied are you with your life? Responses ranging from 1 (very satisfied) to 4 (very dissatisfied) Increases in scores relate to worsening life satisfaction overall | One participant preferred not to answer this question | Mean | Standard Deviation | units on a scale |
|
| Sense of belonging to university | Single item assessing feelings of sense of belonging: I feel part of the UMass Boston community. Scores range from strongly disagree (1) to strongly agree (5) Greater scores reflect greater sense of belonging to the university community | Mean | Standard Deviation | units on a scale |
|
Participants in mentoring program as usual |
|
|
|
| Primary | Self-reported Anxiety Symptoms | General Anxiety Disorder - 7 (GAD-7): Anxiety symptoms over the last two weeks Scores range from 0 (no anxiety symptoms) to 21 (extreme/severe anxiety symptoms) | Some participants opted to skip this measure | Posted | Mean | Standard Deviation | score on a scale | 9 weeks after program start |
|
|
|
|
| Primary | Life Satisfaction | Single item of current life satisfaction: In general, how satisfied are you with your life? Responses ranging from 1 (very satisfied) to 4 (very dissatisfied) | Some participants opted to skip this measure | Posted | Mean | Standard Deviation | units on a scale | 9 weeks after program start |
|
|
|
|
| Secondary | Academic Self-efficacy | Single item of feelings of academic self-efficacy: I am confident that I will be a successful student at UMass Boston. Scores range from strongly disagree (1) to strongly agree (5) Greater scores reflect greater perceived academic self-efficacy | Some participants opted to skip this measure | Posted | Mean | Standard Deviation | units on a scale | 9 weeks after program start |
|
|
|
|
| Secondary | Cognitive Load | Single item assessing cognitive load of finding resources on campus: It can be exhausting to find the information and resources I need to succeed. Scores range from strongly disagree (1) to strongly agree (5) Greater scores reflect greater perceived exhaustion when finding needed resources | Some participants opted to skip this measure | Posted | Mean | Standard Deviation | units on a scale | 9 weeks after program start |
|
|
|
|
| Secondary | Sense of Belonging to the University Community | Single item assessing feelings of sense of belonging: I feel part of the UMass Boston community. Scores range from strongly disagree (1) to strongly agree (5) Greater scores reflect greater sense of belonging to the university community | Some participants opted to skip this measure. | Posted | Mean | Standard Deviation | units on a scale | 9 weeks after program start |
|
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Control | Participants in mentoring program as usual | 0 | 30 | 0 | 30 | 0 | 30 |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|