Well-Being, PsychologicalNCT05764785
Evaluating a Digital Peer Mentoring Platform With College Student Populations
A study testing MentorPRO in people with Well-Being, Psychological and Anxiety, run by Academic Web Pages at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well-Being, Psychological, Anxiety, Depression
- What is being tested?
- MentorPRO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2023to 21 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a current member of the identified summer program (Directions for Student Potential at the University of Massachusetts Boston during the 2023 summer)
- Can speak, read, and write in English
- Has access to a smartphone
- 18-years-old or older
- Any self-reported symptoms of anxiety, depression, life dissatisfaction, or lack of college belonging
Who cannot join
- Not a member of the identified summer program (Directions for Student Potential at the University of Massachusetts Boston during the 2023 summer)
- No access to smartphone
- Cannot speak, read, and write in English
- under 18-years-old
- Not reporting any symptoms of anxiety, depression, life dissatisfaction, or lack of college belonging
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Boston
Boston, Massachusetts, 02125
About this study
Official title: Evaluating the Acceptability, Feasibility, and Efficacy of a Digital Peer Mentoring Platform With College Student Populations
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:
- What is the acceptability and feasibility of the MentorPRO mentoring platform?
- Does mentoring with MentorPRO demonstrate an impact on academic outcomes (i.e., GPA) and indices of wellbeing (i.e., mental health, connectedness, academic self-efficacy, and overall wellbeing) among a diverse sample of incoming or first year college students?
Read more
Participants in the MentorPRO group will:
- Use MentorPRO with their assigned mentors to communicate for 9 weeks about transitioning to college and completing a brief summer course at the university
- Complete surveys about their opinions of MentorPRO
All participants (regardless of group assignment) will:
- Complete surveys about their mental health and overall wellbeing
- Work with a mentor throughout participation in a brief summer course at the university
Read the detailed description
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.
- Conditions
- Well-Being, Psychological, Anxiety, Depression, Mentoring to Support the Transition to College
- Being tested
- MentorPRO
- Medical subject headings
- Psychological Well-Being, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MentorPROBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MentorPRO | Experimental | Participants assigned to use MentorPRO Receives: Behavioral: MentorPRO |
| Control | No intervention | Participants in mentoring program as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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)
Measured: 9 weeks after program start
Secondary outcomes (3)
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
Measured: 9 weeks after program start
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
Measured: 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
Measured: 9 weeks after program start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start22 Jun 2023
- Primary completion21 Aug 2023
- Study completion21 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Well-Being, PsychologicalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants assigned based on the timing of their courses in the summer program
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academic Web Pages
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Massachusetts, Boston, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jean E Rhodes, PhD, Principal investigator, University of Massachusetts, Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764785
- Sponsor's protocol ID
- 375649
- Other IDs
- 1R41MH126795-01A1
- Status last verified
- Oct 2023
- First submitted
- 10 Feb 2023
- Last updated
- 12 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Acceptability, Feasibility, and Efficacy of a Digital Peer Mentoring Platform With College Student Populations
- ClinicalTrials.gov ID
- NCT05764785
- Acronym / sponsor ID
- 375649
- Conditions
- Well-Being, Psychological, Anxiety, Depression, Mentoring to Support the Transition to College
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Academic Web PagesIndustry (pharma, biotech, devices)
- Collaborators
- University of Massachusetts, Boston, National Institute of Mental Health (NIMH)
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 13 Mar 2023 (actual)
- Results
- Posted 12 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the acceptability and feasibility of the MentorPRO mentoring platform?
- Does mentoring with MentorPRO demonstrate an impact on academic outcomes (i.e., GPA) and indices of wellbeing (i.e., mental health, connectedness, academic self-efficacy, and overall wellbeing) among a diverse sample of incoming or first year college students?
Participants in the MentorPRO group will:
- Use MentorPRO with their assigned mentors to communicate for 9 weeks about transitioning to college and completing a brief summer course at the university
- Complete surveys about their opinions of MentorPRO
All participants (regardless of group assignment) will:
- Complete surveys about their mental health and overall wellbeing
- Work with a mentor throughout participation in a brief summer course at the university
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants assigned based on the timing of their courses in the summer program
| Arm | Type | Receives |
|---|---|---|
| MentorPRO | Experimental | Behavioral: MentorPROParticipants assigned to use MentorPRO |
| Control | No intervention | –Participants in mentoring program as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being a current member of the identified summer program (Directions for Student Potential at the University of Massachusetts Boston during the 2023 summer)
- Can speak, read, and write in English
- Has access to a smartphone
- 18-years-old or older
- Any self-reported symptoms of anxiety, depression, life dissatisfaction, or lack of college belonging
Key exclusion criteria (5 listed)
- Not a member of the identified summer program (Directions for Student Potential at the University of Massachusetts Boston during the 2023 summer)
- No access to smartphone
- Cannot speak, read, and write in English
- under 18-years-old
- Not reporting any symptoms of anxiety, depression, life dissatisfaction, or lack of college belonging
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 |
|---|---|---|
| MentorPROMentorPRO 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. | Behavioural | MentorPRO |
Primary outcome
Self-reported Depression Symptoms
Time frame: 9 weeks after program start
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).
Self-reported Anxiety Symptoms
Time frame: 9 weeks after program start
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)
Life Satisfaction
Time frame: 9 weeks after program start
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)
3 secondary outcomes
Academic Self-efficacy
Time frame: 9 weeks after program start
Cognitive Load
Time frame: 9 weeks after program start
Sense of Belonging to the University Community
Time frame: 9 weeks after program start
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no current plan to share individual participant data.
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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.
Jean E Rhodes, PhD principal investigator
University of Massachusetts, Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MentorPRO in people with Well-Being, Psychological and Anxiety, run by Academic Web Pages at 1 site in United States.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 12 Oct 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 12 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-reported Depression Symptoms (time frame: 9 weeks after program start). 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 12 Oct 2023.