International Students Intervention

Sponsor
Purdue University (Other)
Overall Status
Completed
CT.gov ID
NCT04945902
Collaborator
(none)
77
1
3
3.9
19.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Synchronous Intervention
  • Behavioral: Asynchronous Intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
77 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Psychosocial Intervention to Protect Purdue International Students
Actual Study Start Date :
Jan 18, 2021
Actual Primary Completion Date :
May 18, 2021
Actual Study Completion Date :
May 18, 2021

Arms and Interventions

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.

Behavioral: 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.

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.

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.

Behavioral: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline of CCAPS-34 scores to Post-intervention [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

  2. Change from Baseline of DASC-21 scores to Post-intervention [6 weeks]

    DASC-21 assesses depression and anxiety symptoms, average scores will be used [range 0-3], with higher scores indicating worse outcome

  3. Change from Baseline of CCAPS-34 scores to 10 weeks [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

  4. Change from Baseline of DASC-21 scores to 10-weeks [10 weeks]

    DASC-21 assesses depression and anxiety symptoms, average scores will be used [range 0-3], with higher scores indicating worse outcome

Secondary Outcome Measures

  1. Social Connectedness Scale (SCS) [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

  2. Campus Climate [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

  3. Group Session Rating Scale (GSRS) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Purdue University West Lafayette Indiana United States 47907

Sponsors and Collaborators

  • Purdue University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
ZhouLab, Assistant Professor, Purdue University
ClinicalTrials.gov Identifier:
NCT04945902
Other Study ID Numbers:
  • 2020-1334
First Posted:
Jun 30, 2021
Last Update Posted:
Jun 30, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ZhouLab, Assistant Professor, Purdue University

Study Results

No Results Posted as of Jun 30, 2021