- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07259746
Study of Student Flourishing
A Multi-Institutional Longitudinal Randomized Controlled Trial of Student Well-Being Using the Flourish App
The goal of this study is to learn how a science-based mobile app, called Flourish, affects student well-being.
The main questions it aims to answer are:
- Does receiving access to the Flourish app increase well-being (e.g., positive affect, loneliness, belonging) among students?
- Does using the Flourish app in combination with a human buddy/friend lead to better outcomes than using the app alone?
Researchers will compare three different groups to see if and how the Flourish app works to improve student well-being:
- Waitlist Control Group: Students continue with existing school resources.
- Flourish App Group: Students use the Flourish app (a digital toolkit and AI chatbot) twice per week.
- Flourish App + Buddy Group: Students use the Flourish app twice per week with someone else as a "Flourish Buddy".
Participants will:
Be randomly assigned to one of the three groups listed above. Use the app or continue with regular resources for 6 weeks. Complete four short online surveys about their well-being (at the beginning, during the 6 weeks, and at the end).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Julie YA Cachia, PhD
- Phone Number: 650-898-6664
- Email: julie@flouriship.com
Study Contact Backup
- Name: Xuan Zhao, PhD
- Phone Number: 408-412-1555
- Email: xuan@flouriship.com
Study Locations
-
-
British Columbia
-
Victoria, British Columbia, Canada, V8P 5C2
- Recruiting
- University of Victoria
-
Contact:
- Nigel Lou, PhD
- Phone Number: +1 250-721-7553
- Email: nigellou@uvic.ca
-
-
-
-
Canterbury
-
Christchurch, Canterbury, New Zealand, 8140
- Not yet recruiting
- University of Canterbury
-
Contact:
- Kong Meng Liew, PhD
- Phone Number: +64 3 369 3208
- Email: kongmeng.liew@canterbury.ac.nz
-
-
-
-
California
-
Berkeley, California, United States, 94720
- Recruiting
- University of California, Berkeley
-
Contact:
- Juliana Schroeder, PhD
- Phone Number: 510-664-9692
- Email: jschroeder@haas.berkeley.edu
-
Los Altos Hills, California, United States, 94022
- Recruiting
- Foothill College
-
Contact:
- Eta Lin, PhD
- Phone Number: 650-949-7669
- Email: lineta@fhda.edu
-
Orange, California, United States, 92866
- Recruiting
- Chapman University
-
Contact:
- John Hunter, PhD
- Phone Number: 714-516-6148
- Email: johnhunter@chapman.edu
-
-
Colorado
-
Denver, Colorado, United States, 80204
- Not yet recruiting
- University of Colorado Denver
-
Contact:
- Annika Mosier, PhD
- Phone Number: 650-898-6664
- Email: ANNIKA.MOSIER@ucdenver.edu
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96822
- Recruiting
- University of Hawai'i at Mānoa
-
Contact:
- Elizabeth Weitz, MA
- Phone Number: 650-898-6664
- Email: eaweitz@hawaii.edu
-
-
Kansas
-
Manhattan, Kansas, United States, 66506
- Recruiting
- Kansas State University
-
Contact:
- Natalie Solomon, PhD
- Phone Number: 785-532-6850
- Email: ndb@ksu.edu
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02912
- Not yet recruiting
- Brown University
-
Contact:
- Jamie Trost, PhD
- Phone Number: 401-863-2195
- Email: jamie_trost@brown.edu
-
-
Washington
-
Seattle, Washington, United States, 98195
- Not yet recruiting
- University of Washington
-
Contact:
- Delancey Wu, PhD
- Phone Number: 650-898-6664
- Email: dcwu@uw.edu
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53706
- Recruiting
- University of Wisconsin-Madison
-
Contact:
- Stav Atir, PhD
- Phone Number: 608-263-3648
- Email: stav.atir@wisc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Currently a student at one of the participating institutions
- Age 18 or older
- Able to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Flourish app condition
Participants in this condition will gain access to the Flourish app and be instructed to use it at least twice a week for 6 weeks.
|
A mobile application providing a science-based digital toolkit and AI chatbot.
Other Names:
|
|
Experimental: Flourish app with buddies condition
Participants in this condition will gain access to the Flourish app and be instructed to use it at least twice a week for 6 weeks.
In addition, they will be instructed to invite a buddy (e.g., friend, family member) to join them on the app.
|
A mobile application providing a science-based digital toolkit and AI chatbot.
Other Names:
|
|
Active Comparator: MHA Resources
Participants in this condition will continue to use existing school resources and will be provided with information directing them to external Mental Health America (MHA) resources.
Participants in this arm do not receive access to the Flourish app.
|
Access to national mental health resources from Mental Health America, which can be found here: https://mhanational.org/resources/.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subcomponents of Affect Scale
Time Frame: Baseline, bi-weekly for 6 weeks (3 time points)
|
The Subcomponents of Affect Scale (SAS) is an 18-item measure of affect, divided into nine positive and nine negative adjectives.
Positive subscales include calm, well-being, and vigor, while negative subscales include depression, anxiety, and anger.
Participants rate each adjective from 0 (not at all accurate) to 4 (extremely accurate) based on their feelings over the past two weeks.
Total scores for positive and negative affect are summed from their subscales.
|
Baseline, bi-weekly for 6 weeks (3 time points)
|
|
Loneliness
Time Frame: Baseline, bi-weekly for 6 weeks (3 time points)
|
The UCLA 3-Item Loneliness Scale is a brief measure assessing subjective feelings of loneliness and social isolation.
Participants rate each item on a 3-point scale, from 1 (hardly ever) to 3 (often), with higher scores indicating greater loneliness.
|
Baseline, bi-weekly for 6 weeks (3 time points)
|
|
Retention / Enrollment Intention
Time Frame: Baseline, 6 weeks post-baseline
|
Retention intention was assessed using 2 items evaluating students' likelihood of continuing their enrollment.
Participants respond to "How likely are you to stay enrolled next quarter/semester?"
on a 5-point scale from 1 ("Very unlikely") to 5 ("Very likely").
A second item asks, "How often have you considered leaving your college/university in the past semester?"
rated from 1 ("Never") to 5 ("Very often").
Higher scores on the first item indicate greater intention to persist, while higher scores on the second item indicate greater consideration of leaving.
|
Baseline, 6 weeks post-baseline
|
|
Implicit Theories of Emotion
Time Frame: Baseline and 6 weeks post-baseline
|
Implicit theories of emotion were assessed using the Implicit Theories of Emotion Scale, adapted from Dweck's Implicit Theories of Intelligence framework.
The scale includes four items assessing beliefs about whether emotions are malleable (incremental) or fixed (entity).
Participants rate each item on a 6-point scale from 1 ("Strongly disagree") to 6 ("Strongly agree").
The two entity items are reverse-scored, and all items are averaged to create a single score ranging from 1 to 6, with higher scores indicating stronger endorsement of an incremental (malleable) theory of emotion.
|
Baseline and 6 weeks post-baseline
|
|
Perceived Cohesion
Time Frame: Baseline, 6 weeks post-baseline
|
The Perceived Cohesion Scale measures a sense of belonging and morale within a community using a Likert scale from 0 (strongly disagree) to 10 (strongly agree).
For our purposes, we use a single-item version: "I see myself as part of the campus community."
|
Baseline, 6 weeks post-baseline
|
|
Closeness to University
Time Frame: Baseline and 6 weeks post-baseline
|
Closeness to one's university was assessed using a modified single-item Inclusion of Other in the Self measure.
Participants were shown seven pairs of increasingly overlapping circles and asked, "Which picture best describes your relationship with your university?"
Responses range from 1 to 7, with higher scores indicating greater perceived closeness to the university.
|
Baseline and 6 weeks post-baseline
|
|
Perceived Social Support (PSSS-3)
Time Frame: Baseline, bi-weekly for 6 weeks (3 time points)
|
Perceived social support was assessed using a 3-item short form based on the ACO (PSSS-A6) and adapted from the Multidimensional Scale of Perceived Social Support (MSPSS).
Participants rate each item on a 7-point scale from 1 ("Very Strongly Disagree") to 7 ("Very Strongly Agree").
Total scores are summed, yielding a range from 3 to 21, with higher scores indicating greater perceived social support.
|
Baseline, bi-weekly for 6 weeks (3 time points)
|
|
Mindfulness (Mindful Attention Awareness Scale)
Time Frame: Baseline and 6 weeks post-baseline
|
Mindfulness was assessed using a 5-item short form of the Mindful Attention Awareness Scale (MAAS), modified to assess experiences over the past two weeks.
Participants rate each item on a 7-point scale from 0 ("Not at all") to 6 ("Very much").
Items are averaged to create a total score ranging from 0 to 6, with higher scores reflecting lower mindfulness.
For interpretability in analyses, this score is reverse-scored so that higher values indicate greater mindfulness.
|
Baseline and 6 weeks post-baseline
|
|
Resilience
Time Frame: Baseline, 6 weeks post-baseline
|
The Brief Resilience Scale (BRS) is a 6-item measure of stress recovery, rated from 1 (strongly disagree) to 5 (strongly agree).
Higher scores indicate a stronger ability to "bounce back" after setbacks.
|
Baseline, 6 weeks post-baseline
|
|
Flourishing Scale
Time Frame: Baseline, 6 weeks post-baseline
|
The Flourishing Scale is an 8-item measure of psychological well-being.
Respondents rate items from 1 ("Strongly disagree") to 7 ("Strongly agree"), yielding a total score range from 8 to 56.
Higher scores indicate greater well-being and flourishing.
|
Baseline, 6 weeks post-baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression (PHQ-2)
Time Frame: Baseline, bi-weekly for 6 weeks (3 time points)
|
The PHQ-2 is an 2-item measure assessing depression severity over the past two weeks.
Each item scores from 0 ("not at all") to 3 ("nearly every day"), with total scores from 0 to 6. Higher scores indicate greater depression severity.
|
Baseline, bi-weekly for 6 weeks (3 time points)
|
|
Anxiety (GAD-2)
Time Frame: Baseline, bi-weekly for 6 weeks (3 time points)
|
The GAD-2 (Generalized Anxiety Disorder-2) is a 2-item measure assessing anxiety severity.
Each item is rated from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 6. Higher scores indicate greater anxiety severity.
|
Baseline, bi-weekly for 6 weeks (3 time points)
|
|
Perceived Stress (PSS-4)
Time Frame: Baseline, bi-weekly for 6 weeks (3 time points)
|
The PSS-4 (Perceived Stress Scale-4) is a 4-item measure of perceived stress, rated from 0 ("never") to 4 ("very often").
Scores range from 0 to 16, with higher scores indicating greater stress.
|
Baseline, bi-weekly for 6 weeks (3 time points)
|
|
School Perceptions
Time Frame: Baseline, 6 weeks post-baseline
|
School perceptions are measured using two single-item measures from the Healthy Minds Survey.
The first item rates satisfaction with the overall school experience from 1 (very dissatisfied) to 6 (very satisfied).
The second item rates agreement with the statement, "At my school, students' mental and emotional well-being is a priority," on a scale from 1 (strongly agree) to 6 (strongly disagree).
|
Baseline, 6 weeks post-baseline
|
|
Expectations and Experiences of Chatbots
Time Frame: Baseline, 6 weeks post-baseline
|
This measure, adapted from the Working Alliance Inventory - Short Revised (WAI-SR), assesses participants' expectations and experiences with chatbots.
Participants rate anticipated and actual interactions across three areas-Goal, Task, and Bond-on a 5-point scale from 1 (seldom) to 5 (always), with higher scores indicating stronger alignment.
|
Baseline, 6 weeks post-baseline
|
|
Academic Self Efficacy
Time Frame: Baseline, 6 weeks post-baseline
|
The 5-item Academic Self-Efficacy scale measures students' confidence in their ability to succeed academically.
Participants rate their agreement with statements such as "I generally manage to solve difficult academic problems if I try hard enough" on a 5-point scale, from 1 (strongly disagree) to 5 (strongly agree).
Higher scores indicate greater self-belief in tackling academic challenges and achieving study-related goals.
|
Baseline, 6 weeks post-baseline
|
|
Satisfaction With Life
Time Frame: Baseline, bi-weekly for 6 weeks (3 time points)
|
Life satisfaction was assessed using a single-item measure asking, "All things considered, how satisfied are you with your life as a whole?"
Participants respond on an 11-point scale from 0 ("Completely dissatisfied") to 10 ("Completely satisfied").
Higher scores indicate greater overall life satisfaction.
|
Baseline, bi-weekly for 6 weeks (3 time points)
|
|
Multi-Dimensional Measure of Trust
Time Frame: 6 weeks post-baseline
|
The Multi-Dimensional Measure of Trust (MDMT) assesses perceived trustworthiness of the Flourish chatbot, Sunnie, through a set of 10 attributes (Form A), rated from 0 (Not at all) to 5 (Very), with a 'Does Not Fit' option.
Only participants in the intervention conditions (Flourish app; Flourish app + buddies conditions) complete this measure.
|
6 weeks post-baseline
|
|
Perceived Empathy of Sunnie
Time Frame: 6 weeks post-baseline
|
Perceived empathy toward the Flourish chatbot, Sunnie, will be assessed using a 7-item measure.
Participants rate each item from 1 ("Strongly disagree") to 6 ("Strongly agree").
Items are averaged to create a composite score, with higher scores indicating greater perceived empathy.
This was only presented to those in the intervention conditions.
|
6 weeks post-baseline
|
|
Flourish Buddy Responsiveness
Time Frame: Weeks 4 and 6 post-baseline
|
For participants with at least one Flourish Buddy, responsiveness of the selected buddy will be assessed using a 3-item measure assessing how accepted, understood, and cared for participants feel by their buddy.
Items are rated from 1 ("Not at all") to 7 ("Very much") and averaged; higher scores indicate greater perceived responsiveness.
|
Weeks 4 and 6 post-baseline
|
|
Relationship Satisfaction with Flourish Buddy
Time Frame: Weeks 4 and 6 post-baseline
|
For participants with at least one Flourish Buddy, relationship satisfaction with the selected buddy will be assessed using RAS-1, a single item rating overall satisfaction with the relationship from 1 ("Not satisfied") to 5 ("Very satisfied").
Higher scores indicate greater satisfaction.
|
Weeks 4 and 6 post-baseline
|
|
Perceived Relationship Improvement
Time Frame: 6 weeks post-baseline
|
Perceived improvement in the relationship with an existing Flourish Buddy will be assessed using a single item ("To what extent did being Flourish Buddies with this person improve your relationship?").
This item is shown to participants in either Flourish condition who reported having a Flourish Buddy.
Participants rate the item from 1 ("Not at all") to 7 ("Very much").
Higher scores indicate greater perceived improvement.
|
6 weeks post-baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Net Promoter Score (NPS)
Time Frame: 6 weeks post-baseline
|
Intervention satisfaction will be assessed using the Net Promoter Score (NPS).
Participants in the intervention and control conditions will respond to the item: "How likely are you to recommend the Flourish app / MHA resources to a friend or colleague?" on an 11-point scale from 0 ("Not at all likely") to 10 ("Extremely likely").
Higher scores indicate greater likelihood of recommending the intervention.
|
6 weeks post-baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Flourish2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
University of Vermont Medical CenterAvocado Nutrition CenterRecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokersUnited States
-
Dragonfly TherapeuticsRecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult MaleAustralia
-
University of PalermoCompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | StretchingItaly
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Umm Al-Qura UniversityActive, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult SubjectsSaudi Arabia
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
-
PfizerNot yet recruitingHealthy | Healthy AdultsUnited States
-
RAGE BioRecruitingHealthy | Healthy SmokerAustralia
Clinical Trials on Digital toolkit
-
University of Alabama at BirminghamMassachusetts General HospitalNot yet recruitingHIV Prevention | HIV Risk | Sexual and Reproductive HealthUnited States
-
Sheffield Hallam UniversityEnrolling by invitationArthritis Knee | Arthritis of HipUnited Kingdom
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA)Not yet recruitingOpioid Use Disorder
-
Sheffield Hallam UniversitySheffield Teaching Hospitals NHS Foundation TrustActive, not recruitingOsteo Arthritis Knee | Osteoarthritis, HipUnited Kingdom
-
University of BonnUniversity of Leeds; University College Cork; Universidade do Porto; University... and other collaboratorsNot yet recruiting
-
Dana-Farber Cancer InstituteNational Institute on Aging (NIA)Recruiting
-
Sunnybrook Health Sciences CentreScarborough General Hospital; Michael Garron Hospital; York Central Hospital,... and other collaboratorsCompleted
-
Arab Resource CollectiveModern University for Business and ScienceActive, not recruitingMental Health | Self Care | Performance EnhancementLebanon
-
University of MichiganCompletedWomen With BRCA 1 or BRCA 2 Mutation | Non-tested Female Family MembersUnited States