Social IsolationNCT04945902
International Students Intervention
A study testing Synchronous Intervention and Asynchronous Intervention in people with Social Isolation, run by Purdue University at 1 site in United States.
Trial summary
The proposed project aims to provide international students on F-1, J-1, or M-1 visas at Purdue additional culturally-relevant support by implementing and testing a psychosocial intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Isolation
- What is being tested?
- Synchronous Intervention and Asynchronous Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2021to 18 May 2021
- 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
- International students who report being on J-1, F-1, or M-1 visas
- Currently enrolled in classes at Purdue at either the undergraduate or graduate level either remotely or in-person
- 18 years or older
Who cannot join
- active suicidality and/or homicidality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Psychosocial Intervention to Protect Purdue International Students
The proposed project aims to provide international students on F-1, J-1, or M-1 visas at Purdue additional culturally-relevant support by implementing and testing a psychosocial intervention. The intervention was designed based on the results of a recently published research study (Bhojwani et al., 2020) about international student concerns and needs in the time of COVID-19. This intervention is designed to test the effectiveness of a strengths-based intervention that targets the particular needs of international students during COVID. The intervention was designed based on evidence-based Cognitive-Behavioral and Systemic Therapy (Jafar et. al, 2016; Saravanan et. al., 2017) approaches to addressing stress and anxiety in a culturally-relevant manner and to decrease social isolation.
- Conditions
- Social Isolation
- Being tested
- Synchronous Intervention, Asynchronous Intervention
- Keywords
- international students, virtual intervention
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synchronous InterventionBehavioural
Weekly one-hour support groups. These support groups will meet virtually using a restricted WebEx channel and will be recorded. In this support group, students will discuss the weekly activities and build connection and support with each other. This group will be led by advanced doctoral students in counseling psychology and overseen by a counseling psychology faculty member, who is also a licensed psychologist.
Asynchronous InterventionBehavioural
The asynchronous intervention will provide access to information and resources for mental health support via Brightspace. The intervention will be six weeks long and each week will have a topic. The weekly topics include: (1) identifying feelings; (2) biology of emotions; (3) mindfulness; (4) recognizing and responding to stress; (5) mental health stigma; and (6) self-care/self-advocacy. Each week, you will be required to complete four types of activities: education, reflective exercises, an activity, and a short assessment. All of these resources will be provided on Brightspace to be completed on your own time but the activities must be completed during the week they are assigned. You will not have to interact with other international students if you are in the asynchronous intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Asynchronous Group | Active comparator | The asynchronous intervention will provide access to information and resources for mental health support via Brightspace. The intervention will be six weeks long and each week will have a topic. The weekly topics include (1) identifying feelings; (2) biology of emotions; (3) mindfulness; (4) recognizing and responding to stress; (5) mental health stigma; and (6) self-care/self-advocacy. Each week, you will be required to complete four types of activities: education, reflective exercises, an activity, and a short assessment. All of these resources will be provided on Brightspace to be completed on your own time but the activities must be completed during the week they are assigned. You will not have to interact with other international students if you are in the asynchronous intervention group. Receives: Behavioral: Asynchronous Intervention |
| Synchronous Group | Experimental | If you are assigned to the synchronous intervention group, you will be required to complete the asynchronous interventions on Brightspace AND attend a weekly one-hour support group. These support groups will meet virtually using a restricted WebEx channel and will be recorded. In this support group, students will discuss the weekly activities and build connections and support with each other. This group will be led by advanced doctoral students in counseling psychology and overseen by a counseling psychology faculty member, who is also a licensed psychologist. Receives: Behavioral: Synchronous Intervention; Behavioral: Asynchronous Intervention |
| Waitlist | No intervention | If you are assigned to the wait-list group, you will not have access to the asynchronous or synchronous interventions during the course of this study. After this study is completed, you will have access to the asynchronous intervention on Brightspace. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of CCAPS-34 scores to Post-intervention
CCAPS-34 assesses seven domains of psychological symptoms salient to college students, average scores will be used [range 0-4], with higher scores indicating worse outcome
Measured: 6 weeks
Change from Baseline of DASC-21 scores to Post-intervention
DASC-21 assesses depression and anxiety symptoms, average scores will be used [range 0-3], with higher scores indicating worse outcome
Measured: 6 weeks
Change from Baseline of CCAPS-34 scores to 10 weeks
CCAPS-34 assesses seven domains of psychological symptoms salient to college students, average scores will be used [range 0-4], with higher scores indicating worse outcome
Measured: 10 weeks
Change from Baseline of DASC-21 scores to 10-weeks
DASC-21 assesses depression and anxiety symptoms, average scores will be used [range 0-3], with higher scores indicating worse outcome
Measured: 10 weeks
Secondary outcomes (3)
Social Connectedness Scale (SCS)
SCS assesses indivividuals' social connectedness, range from 1 to 6, reverse coded with higher scores indicating better outcome
Measured: through the study completion, an average of 10 weeks
Campus Climate
Adapted from Glass, C. R. (2012). with 6 items to measure students' connection with the university specifically, range 0 to 4, with higher scores indicating better campus climate
Measured: through the study completion, an average of 10 weeks
Group Session Rating Scale (GSRS)
GSRS is only administered for the intervention synchronous group, range from 1 to 10, with higher scores indicating better group cohesion
Measured: weekly for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start18 Jan 2021
- Primary completion18 May 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Social IsolationStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZhouLab, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945902
- Sponsor's protocol ID
- 2020-1334
- Status last verified
- Jun 2021
- First submitted
- 16 Mar 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bhojwani, J., Joy, E., Hoxsey, A., & Case, A. S. (2020). Being an International Student in the Age of COVID-19. Susan Bulkeley Butler Center for Leadership Excellence and ADVANCE Working Paper Series, 3(2), Special Issue: 47-60.
Zhou X, Zhou AQ., & Sun X. Prevalence of common mental concerns and service utilization among international students studying in the US. Counselling Psychology Quarterly. 2021: 1-21.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Psychosocial Intervention to Protect Purdue International Students
- ClinicalTrials.gov ID
- NCT04945902
- Acronym / sponsor ID
- 2020-1334
- Conditions
- Social Isolation
- Keywords
- international students, virtual intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 30 Jun 2021 (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.
The proposed project aims to provide international students on F-1, J-1, or M-1 visas at Purdue additional culturally-relevant support by implementing and testing a psychosocial intervention. The intervention was designed based on the results of a recently published research study (Bhojwani et al., 2020) about international student concerns and needs in the time of COVID-19. This intervention is designed to test the effectiveness of a strengths-based intervention that targets the particular needs of international students during COVID. The intervention was designed based on evidence-based Cognitive-Behavioral and Systemic Therapy (Jafar et. al, 2016; Saravanan et. al., 2017) approaches to addressing stress and anxiety in a culturally-relevant manner and to decrease social isolation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asynchronous Group | Active comparator | Behavioral: Asynchronous InterventionThe asynchronous intervention will provide access to information and resources for mental health support via Brightspace. The intervention will be six weeks long and each week will have a topic. The weekly topics include (1) identifying feelings; (2) biology of emotions; (3) mindfulness; (4) recognizing and responding to stress; (5) mental health stigma; and (6) self-care/self-advocacy. Each week, you will be required to complete four types of activities: education, reflective exercises, an activity, and a short assessment. All of these resources will be provided on Brightspace to be completed on your own time but the activities must be completed during the week they are assigned. You will not have to interact with other international students if you are in the asynchronous intervention group. |
| Synchronous Group | Experimental | Behavioral: Synchronous Intervention, Behavioral: Asynchronous InterventionIf you are assigned to the synchronous intervention group, you will be required to complete the asynchronous interventions on Brightspace AND attend a weekly one-hour support group. These support groups will meet virtually using a restricted WebEx channel and will be recorded. In this support group, students will discuss the weekly activities and build connections and support with each other. This group will be led by advanced doctoral students in counseling psychology and overseen by a counseling psychology faculty member, who is also a licensed psychologist. |
| Waitlist | No intervention | –If you are assigned to the wait-list group, you will not have access to the asynchronous or synchronous interventions during the course of this study. After this study is completed, you will have access to the asynchronous intervention on Brightspace. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- International students who report being on J-1, F-1, or M-1 visas
- Currently enrolled in classes at Purdue at either the undergraduate or graduate level either remotely or in-person
- 18 years or older
Key exclusion criteria (1 listed)
- active suicidality and/or homicidality
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 |
|---|---|---|
| Synchronous InterventionWeekly one-hour support groups. These support groups will meet virtually using a restricted WebEx channel and will be recorded. In this support group, students will discuss the weekly activities and build connection and support with each other. This group will be led by advanced doctoral students in counseling psychology and overseen by a counseling psychology faculty member, who is also a licensed psychologist. | Behavioural | Synchronous Group |
| Asynchronous InterventionThe asynchronous intervention will provide access to information and resources for mental health support via Brightspace. The intervention will be six weeks long and each week will have a topic. The weekly topics include: (1) identifying feelings; (2) biology of emotions; (3) mindfulness; (4) recognizing and responding to stress; (5) mental health stigma; and (6) self-care/self-advocacy. Each week, you will be required to complete four types of activities: education, reflective exercises, an activity, and a short assessment. All of these resources will be provided on Brightspace to be completed on your own time but the activities must be completed during the week they are assigned. You will not have to interact with other international students if you are in the asynchronous intervention group. | Behavioural | Asynchronous Group, Synchronous Group |
Primary outcome
Change from Baseline of CCAPS-34 scores to Post-intervention
Time frame: 6 weeks
CCAPS-34 assesses seven domains of psychological symptoms salient to college students, average scores will be used [range 0-4], with higher scores indicating worse outcome
Change from Baseline of DASC-21 scores to Post-intervention
Time frame: 6 weeks
DASC-21 assesses depression and anxiety symptoms, average scores will be used [range 0-3], with higher scores indicating worse outcome
Change from Baseline of CCAPS-34 scores to 10 weeks
Time frame: 10 weeks
CCAPS-34 assesses seven domains of psychological symptoms salient to college students, average scores will be used [range 0-4], with higher scores indicating worse outcome
Change from Baseline of DASC-21 scores to 10-weeks
Time frame: 10 weeks
DASC-21 assesses depression and anxiety symptoms, average scores will be used [range 0-3], with higher scores indicating worse outcome
3 secondary outcomes
Social Connectedness Scale (SCS)
Time frame: through the study completion, an average of 10 weeks
Campus Climate
Time frame: through the study completion, an average of 10 weeks
Group Session Rating Scale (GSRS)
Time frame: weekly for 6 weeks
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 30 Jun 2021.
- BackgroundBhojwani, J., Joy, E., Hoxsey, A., & Case, A. S. (2020). Being an International Student in the Age of COVID-19. Susan Bulkeley Butler Center for Leadership Excellence and ADVANCE Working Paper Series, 3(2), Special Issue: 47-60.
- BackgroundZhou X, Zhou AQ., & Sun X. Prevalence of common mental concerns and service utilization among international students studying in the US. Counselling Psychology Quarterly. 2021: 1-21.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synchronous Intervention and Asynchronous Intervention in people with Social Isolation, run by Purdue University 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 3 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 30 Jun 2021. 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. 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?
Change from Baseline of CCAPS-34 scores to Post-intervention (time frame: 6 weeks). 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?
On the ClinicalTrials.gov record for NCT04945902, which also lists 2 linked publications.
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 30 Jun 2021.