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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04945902
Other study ID # 2020-1334
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 18, 2021
Est. completion date May 18, 2021

Study information

Verified date June 2021
Source Purdue University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date May 18, 2021
Est. primary completion date May 18, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Synchronous Intervention
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 Intervention
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.

Locations

Country Name City State
United States Purdue University West Lafayette Indiana

Sponsors (1)

Lead Sponsor Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 weeks
Primary 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 6 weeks
Primary 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 10 weeks
Primary 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 10 weeks
Secondary Social Connectedness Scale (SCS) 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
Secondary 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 through the study completion, an average of 10 weeks
Secondary 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 weekly for 6 weeks
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