Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05764785
Other study ID # 375649
Secondary ID 1R41MH126795-01A
Status Completed
Phase N/A
First received
Last updated
Start date June 22, 2023
Est. completion date August 21, 2023

Study information

Verified date October 2023
Source Academic Web Pages
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date August 21, 2023
Est. primary completion date August 21, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - 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 Exclusion criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
United States University of Massachusetts Boston Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Academic Web Pages National Institute of Mental Health (NIMH), University of Massachusetts, Boston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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). 9 weeks after program start
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) 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) 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
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
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
9 weeks after program start
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A