- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05294913
Enhancing Emotional and Motivational Development to Support Well-being and Retention in Diverse University Students
Enhancing Emotional and Motivational Development in the University to Support Well-being and Retention in Diverse University Students
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85721
- University of Arizona
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
|
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.
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Placebo Comparator: Placebo control group
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Salivary diurnal cortisol pattern change (from baseline to end-of-semester)
Time Frame: 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.
|
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 C-reactive protein change (from baseline to end-of-semester)
Time Frame: 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
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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)
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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
|
|
Acculturative stress change (from baseline to end-of-semester)
Time Frame: 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).
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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
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Quality of life (visual analogue) change (from baseline to end-of-semester)
Time Frame: 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
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Quality of life will be assessed using a visual analogue (sliding scale from 0-100)
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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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Katherine C Cheng, PhD, Assistant Research Professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- 2104695049
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.
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