NCT05294913

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

January 18, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2025

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

2.9 years

First QC Date

May 10, 2021

Last Update Submit

April 8, 2025

Conditions

Keywords

emotion regulationfuture-oriented motivationsalivary biomarkersacculturative stresssalivary cortisolC-reactive protein

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Intervention group

EXPERIMENTAL
Behavioral: Contextualized Wish-Outcome-Obstacle-Plan (WOOP) intervention

Placebo control group

PLACEBO COMPARATOR
Behavioral: Placebo

Interventions

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.

Intervention group
PlaceboBEHAVIORAL

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.

Placebo control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721, United States

Location

MeSH Terms

Conditions

Emotional Regulation

Interventions

Methods

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Katherine C Cheng, PhD

    Assistant Research Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 10, 2021

First Posted

March 24, 2022

Study Start

January 18, 2022

Primary Completion

December 17, 2024

Study Completion

April 8, 2025

Last Updated

April 10, 2025

Record last verified: 2025-04

Locations