- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06454851
A VR Intervention for Promoting Prosocial Behavior and Well-being in Youth
A Virtual Reality (VR) Intervention for Promoting Prosocial Behavior and Well-being in Youth Transitioning From Secondary to Tertiary Education: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Targeting youth transitioning from secondary to tertiary education, the proposed project will adopt evidence-based intervention programs that use digital technologies to promote prosocial behavior and well-being, thereby supporting better intrapersonal and interpersonal development.
The investigators aim to develop a gamified prosocial VR intervention for youth transitioning from secondary to tertiary education and to test its effectiveness through a randomized controlled trial (RCT).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tao Zhang
- Phone Number: 852-9423-3827
- Email: tao-t.zhang@connect.polyu.hk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 15-19
- Secondary 6 to college year 1
- Can read traditional Chinese and understand Cantonese
Exclusion Criteria:
- History of photosensitive epilepsy
- Impairment of stereoscopic vision
- Balance problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VR Intervention group
Participants in the intervention condition will be required to complete a 4-session gamified prosocial VR intervention program, one session a week for four consecutive weeks, each session lasts around 15-20 minutes.
|
A four-week gamified prosocial VR intervention program based on literature review and relevance to the local contexts will be developed for the proposed project.
The intervention will be expanded to include four weekly sessions, each lasting between 15 to 20 minutes.
Each session will depict a different daily life scenario-campus, lecture hall, canteen, and library, respectively.
During each session, participants will engage in a series of tasks that incorporate elements of prosocial behavior or helping actions within the scene.
These tasks are designed to be more comprehensive and interactive, ensuring that participants are fully immersed in the experience for the entire duration of the session.
|
|
Sham Comparator: Waitlist control group
Participants in the waitlist condition will be asked to continue their usual activity routines before their turn to receive the intervention.
|
The waitlist control group will not receive the intervention during the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prosocial behavior
Time Frame: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
The Prosocialness Scale for Adults (PSA) will be used to measure prosocial behavior.
Each item will be rated on a 5-point Likert scale, ranging from 1 (never/almost never true) to 5 (almost always/always true).
Higher scores indicate a higher level of prosocial behavior.
|
Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
|
Prosocial attitudes
Time Frame: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
Three items of prosocial attitudes will be revised from the Prosocial Orientation Questionnaire.
Each item will be rated on a 6-point Likert scale, ranging from 1 (strongly disagree) to 6 (strongly agree).
Higher scores indicate more positive prosocial attitudes.
|
Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
|
Prosocial identity
Time Frame: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
The Internalization subscale of the Self Importance of Moral Identity Scale (SIMIS) will be adapted to assess the prosocial identity.
Each item will be rated on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree).
Higher scores indicate a higher level of Prosocial identity.
|
Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
|
Prosocial intention
Time Frame: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
The Prosocial Behavioral Intentions Scale (PBIS) will be used to assess people's intentions to behave prosocially in the future.
Each item will be rated on a 7-point Likert scale, ranging 1 (Definitely would not do this) to 7 (Definitely would do this).
Higher scores indicate a higher level of prosocial intention.
|
Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
|
Attitudes toward helping others
Time Frame: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
The Attitudes toward helping others scale (AHO) will be used to test attitudes towards helping others.
Each item will be rated on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree).
Higher scores indicate more positive attitudes toward helping others.
|
Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
|
Altruism
Time Frame: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
Two items from Preference Survey Module (PSM) will be adapted to assess altruism.
For example, one item is: "Imagine the following situation: you won 1,000 Euro in a lottery.
Considering your current situation, how much would you donate to charity? (Values between 0 and 1000 are allowed)".
Elevated scores on this item reflect a greater degree of altruistic.
|
Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
|
Online prosocial behavior
Time Frame: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
The Online Prosocial Behavior Scale (OPBS) will be used to measure online prosocial behavior.
Each item will be rated on a 7-point Likert scale, ranging 1 (never) to 7 (always).
Higher scores indicate a higher level of online prosocial behavior.
|
Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
|
Empathy
Time Frame: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
The Single Item Trait Empathy Scale (SITES) will be used to measure empathy.
This item will be rated on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree), with a higher score indicates a higher level of empathy.
|
Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
|
Subjective happiness
Time Frame: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
The Subjective Happiness Scale (SHS) will be used to measure participants' subjective happiness.
Each item will be rated on a 7-point Likert scale.
Higher scores indicate a higher level of subjective happiness.
|
Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
|
Life satisfaction
Time Frame: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
The Satisfaction with Life Scale (SWLS) will be used to measure life satisfaction.
Each item will be rated on a 7-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree.
Higher scores indicate higher levels of life satisfaction.
|
Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
|
Flourishing
Time Frame: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
The Flourishing Scale (FS) will be used to measure flourishing.
Each statement is answered using a 7-point Likert scale (7 - strongly agree to 1 - strongly).
Higher scores indicate a higher level of flourishing.
|
Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
|
Self-esteem
Time Frame: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
The Rosenberg Self-esteem Scale (RSE) will be used to measure self-esteem.
Each item will be rated on a 4-point Likert scale, ranging from 1 (strongly agree) to 4(strongly disagree).
Higher scores indicate higher levels of self-esteem.
|
Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
|
Affect
Time Frame: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
The Emmons Mood Indicator will used to measure affect.
it measures two dimensions: Positive Affect and Negative Affect.
Each item will be rated on a 7-point Likert scale, ranging from 1 (not at all) to 7 (extremely).
Higher scores indicate a higher level of affect.
|
Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
|
Mental health
Time Frame: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
The Patient Health Questionnaire-4 (PHQ-4) will be used to measure mental health.
Each item will be rated on a 4-point Likert scale: "0" for "not at all," "1" for "several days," "2" for "more than half the days," and "3" for "nearly every day."
Higher scores suggest a higher likelihood of experiencing significant depression and anxiety symptoms.
|
Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
|
|
Diary measures
Time Frame: Daily monitoring for four weeks during the intervention
|
State prosocial behavior outcomes and well-being outcomes will be measured.
|
Daily monitoring for four weeks during the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feelings in the VR
Time Frame: immediately after the intervention (post-intervention)
|
Two items will be uesd to measure the sense of reality.
Items are "I feel that the maze seemed very much like the one in the real world" and "The game scene made me feel like I was truly there".
|
immediately after the intervention (post-intervention)
|
|
Levels of difficulty
Time Frame: immediately after the intervention (post-intervention)
|
Two items will be used to measure the levels of difficulty.
Items are "The game is very difficult" and "The game is too difficult to operate".
|
immediately after the intervention (post-intervention)
|
|
Levels of interest
Time Frame: immediately after the intervention (post-intervention)
|
Two items will be used to measure the levels of difficulty.
Items are "This game is very interesting" and "I like this game".
|
immediately after the intervention (post-intervention)
|
|
Intervention satisfaction
Time Frame: immediately after the intervention (post-intervention and only in the last week)
|
The Client Satisfaction Questionnaire-8 (CSQ-8) will used to test Intervention satisfaction.
Each item will be rated on a 4-point Likert scale where "1" indicates the lowest degree of satisfaction and "4," the highest.
Higher scores indicate higher intervention satisfaction.
|
immediately after the intervention (post-intervention and only in the last week)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Socio-demographic variables
Time Frame: Baseline (pre-intervention)
|
The following socio-demographic variables such as gender, age, level of education, and family income will be collected.
|
Baseline (pre-intervention)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sylvia CHEN, Ph.D., The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HSEARS20240214005-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Youth
-
Charles Drew University of Medicine and ScienceLos Angeles County Department of Public HealthWithdrawnHealth Equity | Youth Participatory Action Research | Youth Mental Health
-
Midwest Evaluation & ResearchImperial Valley Regional Occupational Program (IVROP)Completed
-
Midwest Evaluation & ResearchAvance Clinical Pty Ltd.Completed
-
Unity Health TorontoCovenant House Toronto; Ontario Trillium Foundation; dk LeadershipCompleted
-
Montana State UniversityCompleted
-
Unity Health TorontoCovenant House Toronto; StepStones for Youth; Resource Association for TeensCompleted
-
Centre for Addiction and Mental HealthCompletedHomelessness | YouthCanada
-
Unity Health TorontoCovenant House Toronto; StepStones for Youth; Resource Association for TeensRecruiting
-
Unity Health TorontoCovenant House Toronto; StepStones for Youth; Living Rock Ministries; Resource...Completed
-
Murdoch Childrens Research InstituteRoyal Children's Hospital; RCH League of Former Trainees and Associates IncCompletedHomeless YouthAustralia
Clinical Trials on Prosocial VR intervention
-
The Hong Kong Polytechnic UniversityNot yet recruiting
-
University of Wisconsin, MadisonCompleted
-
University of CyprusYouth Board of CyprusCompleted
-
Institute of Mental Health, SingaporeRecruiting
-
Mayo ClinicRecruitingDepression | Malignant Solid Neoplasm | Cancer | Hematopoietic and Lymphoid System Neoplasm | Adjustment Disorder | Anxiety DisorderUnited States
-
Wake Forest University Health SciencesNational Heart, Lung, and Blood Institute (NHLBI)CompletedPhysical ActivityUnited States
-
Hong Kong Shue Yan UniversityNot yet recruitingSocial Phobia | Social Anxiety Disorder (SAD)
-
University Hospital, Basel, SwitzerlandCompletedPostoperative PainSwitzerland
-
Universite du Quebec en OutaouaisFonds de la Recherche en Santé du Québec; Canadian Research Chair in Family...Unknown
-
Danderyd HospitalStiftelsen PromobilaNot yet recruitingAcquired Brain Injury (Including Stroke)Sweden