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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05294913
• Other study ID #: 2104695049
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2022
• Est. completion date: July 2023

Study information

• Verified date: March 2022
• Source: University of Arizona
• Contact: Katherine C Cheng, PhD
• Phone: 5206215352
• Email: katcheng[@]arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Contextualized Wish-Outcome-Obstacle-Plan (WOOP) intervention
This intervention will ask students to identify socio-culturally integrated academic or personal goals, so that students may be able to better strategize obstacle-overcoming to attain their future academic aspirations and modulate negative emotions or environments and associated physiological responses.
• Placebo
The placebo control group will receive a 5- to 10-minute online goal-setting video tutorial and confirm that they have completed it by filling out an online check-list.

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary diurnal cortisol pattern change (from baseline to end-of-semester)	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.	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
Primary	Salivary C-reactive protein change (from baseline to end-of-semester)	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)	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
Primary	Acculturative stress change (from baseline to end-of-semester)	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).	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
Primary	Quality of life (visual analogue) change (from baseline to end-of-semester)	Quality of life will be assessed using a visual analogue (sliding scale from 0-100)	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