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临床试验/NCT05294913
NCT05294913已完成不适用

Enhancing Emotional and Motivational Development in the University to Support Well-being and Retention in Diverse University Students

University of Arizona2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2022年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
2
主要终点
Salivary C-reactive protein change (from baseline to end-of-semester)

研究概览

简要总结

Higher education is crucial for young adults in their intake of knowledge and skills to further their careers and reach their potentials. However, going through college is not necessarily an easy path. The purpose of this study is to enhance university students' well-being and educational experience by examining factors associated with stress and well-being.

The investigator plans to recruit eighty participants from a large public university in the US to provide survey data and saliva samples at two waves during the data collection semester (beginning and end of the semester). Survey data will include demographic information and help gauge psychosocial factors related to stress and well-being. Saliva will be tested for two biomarkers each wave of data collection, cortisol (sampling three times a day for diurnal patterns for two consecutive days) and c-reactive protein, which indicate physiological stress/immune responses. Additionally, participants be randomly assigned to an intervention (n = 40) or control group (n = 40), where the intervention group will undertake a brief intervention focused on motivation and emotion regulation circa mid-semester and the control group will receive a placebo goal-setting short training. The investigator aims to examine whether intervention efforts can enhance end-of-semester psychological and physiological well-being, and particularly, whether students from diverse backgrounds (e.g., first-generation, low-income, and/or BIPOC) can benefit from the intervention.

The investigator will use advanced quantitative data analysis (using Mplus v.8, in a structural equation modeling framework) to examine intervention efficacy and group differences. The investigator hypothesizes that those receiving the intervention will display a healthier profile at the end of the semester compared to their control group counterparts; and the investigator hypothesize students from diverse backgrounds will have significantly improved results from the intervention.

The study will allow a better understanding to crucial steps towards exploring how to improve the well-being, higher-education pipeline, and retention of students with diverse backgrounds, providing insight on how each student's university experience can be improved.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Participants will not know which group they are assigned to. Each participant will receive a debriefing form at the end of the study for transparency, and control group participants will also receive the intervention kit at the completion of the study for equal opportunity.

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

  • participants who are currently enrolled students at a large public university in the Southwest of US.

排除标准

  • individuals below the age of 18 or those who are not currently enrolled students at said university.

结局指标

主要结局

Salivary C-reactive protein change (from baseline to end-of-semester)

时间窗: Saliva samples will be collected for two consecutive days per wave, one time per day and averaged for reliability, at Wave 1 (baseline, Week 3 of semester) and Wave 2 (end-of-semester, circa Week 16) of data collection

Salivary C-reactive protein (pg/mL) samples will be used to gauge participant well-being (as an inflammatory marker and risk factor for poor health)

Salivary diurnal cortisol pattern change (from baseline to end-of-semester)

时间窗: Salivary cortisol samples will be collected for two consecutive days per wave, three times per day (upon-awakening, 30-min after wake, and before bedtime), at Wave 1 (baseline, Week 3 of semester) and Wave 2 (end-of-semester, Week 16) of data collection

Salivary cortisol (µg/dL) samples will be used to examine Hypothalamic-pituitary-adrenal-axis regulation and diurnal patterns of cortisol levels as a primary outcome.

Acculturative stress change (from baseline to end-of-semester)

时间窗: Assessed once per wave at Wave 1 (baseline, circa Week 3 of semester) and Wave 2 (circa Week 16, end-of-semester) of data collection

Acculturative stress will be assessed using the Societal, Attitudinal, Environment, and Familial Acculturation Stress scale (Mena et al., 1987), 24 items, 6-point Likert scale (0 = does not apply to 5 = extremely stressful), higher scores indicate more stress (worse outcome).

Quality of life (visual analogue) change (from baseline to end-of-semester)

时间窗: Assessed once per wave at Wave 1 (baseline, circa Week 3 of semester) and Wave 2 (circa Week 16, end-of-semester) of data collection

Quality of life will be assessed using a visual analogue (sliding scale from 0-100)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katherine Cheng, PhD

Assistant Professor

University of Arizona

研究点 (2)

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