- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04945902
International Students Intervention
June 22, 2021 updated by: ZhouLab, Purdue University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
77
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
West Lafayette, Indiana, United States, 47907
- Purdue University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
• active suicidality and/or homicidality
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Asynchronous Group
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.
|
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.
|
Experimental: Synchronous Group
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.
|
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.
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.
|
No Intervention: Waitlist
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 weeks
|
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
|
6 weeks
|
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
|
10 weeks
|
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
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social Connectedness Scale (SCS)
Time Frame: through the study completion, an average of 10 weeks
|
SCS assesses indivividuals' social connectedness, range from 1 to 6, reverse coded with higher scores indicating better outcome
|
through the study completion, an average of 10 weeks
|
Campus Climate
Time Frame: through the study completion, an average of 10 weeks
|
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
|
through the study completion, an average of 10 weeks
|
Group Session Rating Scale (GSRS)
Time Frame: weekly for 6 weeks
|
GSRS is only administered for the intervention synchronous group, range from 1 to 10, with higher scores indicating better group cohesion
|
weekly for 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 18, 2021
Primary Completion (Actual)
May 18, 2021
Study Completion (Actual)
May 18, 2021
Study Registration Dates
First Submitted
March 16, 2021
First Submitted That Met QC Criteria
June 22, 2021
First Posted (Actual)
June 30, 2021
Study Record Updates
Last Update Posted (Actual)
June 30, 2021
Last Update Submitted That Met QC Criteria
June 22, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2020-1334
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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