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临床试验/NCT07259746
NCT07259746招募中不适用

A Multi-Institutional Longitudinal Randomized Controlled Trial of Student Well-Being Using the Flourish App

Flourish Science, Inc.13 个研究点 分布在 3 个国家目标入组 2,500 人开始时间: 2025年9月22日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,500
试验地点
13
主要终点
Subcomponents of Affect Scale

研究概览

简要总结

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:

  1. Does receiving access to the Flourish app increase well-being (e.g., positive affect, loneliness, belonging) among students?
  2. 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:

  1. Waitlist Control Group: Students continue with existing school resources.
  2. Flourish App Group: Students use the Flourish app (a digital toolkit and AI chatbot) twice per week.
  3. 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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Currently a student at one of the participating institutions
  • Age 18 or older
  • Able to provide informed consent

排除标准

  • 未提供

结局指标

主要结局

Subcomponents of Affect Scale

时间窗: 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.

Loneliness

时间窗: 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.

Perceived Cohesion

时间窗: 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."

Closeness to University

时间窗: 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.

Resilience

时间窗: 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.

Retention / Enrollment Intention

时间窗: 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.

Subcomponents of Affect Scale

时间窗: 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.

Implicit Theories of Emotion

时间窗: 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.

Loneliness

时间窗: 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.

Perceived Cohesion

时间窗: 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."

Closeness to University

时间窗: 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.

Perceived Social Support (PSSS-3)

时间窗: 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.

Mindfulness (Mindful Attention Awareness Scale)

时间窗: 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.

Resilience

时间窗: 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.

Flourishing Scale

时间窗: 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.

Retention / Enrollment Intention

时间窗: 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.

次要结局

  • Anxiety (GAD-2)(Baseline, bi-weekly for 6 weeks (3 time points))
  • Perceived Stress (PSS-4)(Baseline, bi-weekly for 6 weeks (3 time points))
  • Academic Self Efficacy(Baseline, 6 weeks post-baseline)
  • Satisfaction With Life(Baseline, bi-weekly for 6 weeks (3 time points))
  • School Perceptions(Baseline, 6 weeks post-baseline)
  • Multi-Dimensional Measure of Trust(6 weeks post-baseline)
  • Expectations and Experiences of Chatbots(Baseline, 6 weeks post-baseline)
  • Perceived Empathy of Sunnie(6 weeks post-baseline)
  • Perceived Relationship Improvement(6 weeks post-baseline)
  • Depression (PHQ-2)(Baseline, bi-weekly for 6 weeks (3 time points))
  • Anxiety (GAD-2)(Baseline, bi-weekly for 6 weeks (3 time points))
  • Perceived Stress (PSS-4)(Baseline, bi-weekly for 6 weeks (3 time points))
  • Expectations and Experiences of Chatbots(Baseline, 6 weeks post-baseline)
  • Academic Self Efficacy(Baseline, 6 weeks post-baseline)
  • Satisfaction With Life(Baseline, bi-weekly for 6 weeks (3 time points))
  • School Perceptions(Baseline, 6 weeks post-baseline)
  • Multi-Dimensional Measure of Trust(6 weeks post-baseline)
  • Flourish Buddy Responsiveness(Weeks 4 and 6 post-baseline)
  • Perceived Relationship Improvement(6 weeks post-baseline)
  • Perceived Empathy of Sunnie(6 weeks post-baseline)
  • Relationship Satisfaction with Flourish Buddy(Weeks 4 and 6 post-baseline)

研究者

发起方
Flourish Science, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (13)

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