HealthyNCT05294913
Enhancing Emotional and Motivational Development to Support Well-being and Retention in Diverse University Students
A study testing Contextualized Wish-Outcome-Obstacle-Plan (WOOP) intervention in people with Healthy, run by University of Arizona at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Contextualized Wish-Outcome-Obstacle-Plan (WOOP) intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2022to 8 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participants who are currently enrolled students at a large public university in the Southwest of US.
Who cannot join
- individuals below the age of 18 or those who are not currently enrolled students at said university.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Healthy
- Being tested
- Contextualized Wish-Outcome-Obstacle-Plan (WOOP) intervention, Placebo
- Keywords
- emotion regulation, future-oriented motivation, salivary biomarkers, acculturative stress, salivary cortisol, C-reactive protein
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contextualized Wish-Outcome-Obstacle-Plan (WOOP) interventionBehavioural
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.
PlaceboBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: Contextualized Wish-Outcome-Obstacle-Plan (WOOP) intervention |
| Placebo control group | Placebo comparator | Not described Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start18 Jan 2022
- Primary completion17 Dec 2024
- Study completion8 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Cheng, PhD, University of Arizona
- Investigators
- Katherine C Cheng, PhD, Principal investigator, Assistant Research Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294913
- Sponsor's protocol ID
- 2104695049
- Status last verified
- Apr 2025
- First submitted
- 10 May 2021
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Emotional and Motivational Development in the University to Support Well-being and Retention in Diverse University Students
- ClinicalTrials.gov ID
- NCT05294913
- Acronym / sponsor ID
- 2104695049
- Conditions
- Healthy
- Keywords
- emotion regulation, future-oriented motivation, salivary biomarkers, acculturative stress, salivary cortisol, C-reactive protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Contextualized Wish-Outcome-Obstacle-Plan (WOOP) intervention |
| Placebo control group | Placebo comparator | Behavioral: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participants who are currently enrolled students at a large public university in the Southwest of US.
Key exclusion criteria (1 listed)
- individuals below the age of 18 or those who are not currently enrolled students at said university.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contextualized Wish-Outcome-Obstacle-Plan (WOOP) interventionThis 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. | Behavioural | Intervention group |
| PlaceboThe 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. | Behavioural | Placebo control group |
Primary outcome
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 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
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)
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).
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
Quality of life will be assessed using a visual analogue (sliding scale from 0-100)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine C Cheng, PhD principal investigator
Assistant Research Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contextualized Wish-Outcome-Obstacle-Plan (WOOP) intervention in people with Healthy, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.