Clinical trial NCT05294913: Enhancing Emotional and Motivational Development to Support Well-being and Retention in Diverse University Students
Official title: Enhancing Emotional and Motivational Development in the University to Support Well-being and Retention in Diverse University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: emotion regulation
future-oriented motivation
salivary biomarkers
acculturative stress
salivary cortisol
C-reactive protein
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Upon study enrollment, participants will be randomly assigned to either the placebo control group, or the intervention group. We will ask all participants to complete two waves of data collection on survey data and salivary samples (Wave 1 \[W1\] data collection will occur at the beginning of the semester; Wave 2 \[W2\] data collection will occur near the end of the semester). Between W1 and W2 data collection (circa mid-semester), each group will receive instructions on an intervention (placebo for the control group), and we will assess if there are any outcome differences between the two groups at the end of the semester.
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Salivary diurnal cortisol pattern change (from baseline to end-of-semester)
timeFrame: 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
measure: Salivary C-reactive protein change (from baseline to end-of-semester)
timeFrame: 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
measure: Acculturative stress change (from baseline to end-of-semester)
timeFrame: 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
measure: Quality of life (visual analogue) change (from baseline to end-of-semester)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: Assistant Research Professor
name: Katherine C Cheng, PhD
role: PRINCIPAL_INVESTIGATOR
References: