NCT04945902

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

March 16, 2021

Last Update Submit

June 22, 2021

Conditions

Keywords

international studentsvirtual intervention

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (3)

  • Social Connectedness Scale (SCS)

    through the study completion, an average of 10 weeks

  • Campus Climate

    through the study completion, an average of 10 weeks

  • Group Session Rating Scale (GSRS)

    weekly for 6 weeks

Study Arms (3)

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.

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.

Behavioral: Synchronous InterventionBehavioral: 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.

Interventions

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.

Synchronous 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.

Asynchronous GroupSynchronous Group

Eligibility Criteria

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

You may qualify if:

  • 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
  • years or older

You may not qualify if:

  • active suicidality and/or homicidality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related 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.

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 16, 2021

First Posted

June 30, 2021

Study Start

January 18, 2021

Primary Completion

May 18, 2021

Study Completion

May 18, 2021

Last Updated

June 30, 2021

Record last verified: 2021-06

Locations