YouthNCT06454851
A VR Intervention for Promoting Prosocial Behavior and Well-being in Youth
A study testing Prosocial VR intervention in people with Youth, run by The Hong Kong Polytechnic University.
Trial summary
The objective of the present project is to develop a gamified prosocial VR intervention for youth transitioning from secondary to tertiary education, and to test the effectiveness of the gamified prosocial VR intervention for promoting prosocial behavior and well-being. Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Youth
- What is being tested?
- Prosocial VR intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 15-19
- Secondary 6 to college year 1
- Can read traditional Chinese and understand Cantonese
Who cannot join
- History of photosensitive epilepsy
- Impairment of stereoscopic vision
- Balance problems
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Virtual Reality (VR) Intervention for Promoting Prosocial Behavior and Well-being in Youth Transitioning From Secondary to Tertiary Education: A Randomized Controlled Trial
The objective of the present project is to develop a gamified prosocial VR intervention for youth transitioning from secondary to tertiary education, and to test the effectiveness of the gamified prosocial VR intervention for promoting prosocial behavior and well-being.
Read the 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).
- Conditions
- Youth
- Being tested
- Prosocial VR intervention, No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosocial VR interventionBehavioural
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.
No interventionOther
The waitlist control group will not receive the intervention during the study.
| Study group | Role | What they receive |
|---|---|---|
| VR Intervention group | Experimental | 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. Receives: Behavioral: Prosocial VR intervention |
| Waitlist control group | Sham comparator | Participants in the waitlist condition will be asked to continue their usual activity routines before their turn to receive the intervention. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosocial behavior
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.
Measured: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
Prosocial attitudes
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.
Measured: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
Prosocial identity
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.
Measured: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
Prosocial intention
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.
Measured: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
Attitudes toward helping others
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.
Measured: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
Altruism
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.
Measured: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
Online prosocial behavior
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.
Measured: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
Empathy
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.
Measured: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
Subjective happiness
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.
Measured: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
Life satisfaction
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.
Measured: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
Flourishing
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.
Measured: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
Self-esteem
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.
Measured: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
Affect
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.
Measured: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
Mental health
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.
Measured: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)
Diary measures
State prosocial behavior outcomes and well-being outcomes will be measured.
Measured: Daily monitoring for four weeks during the intervention
Secondary outcomes (4)
Feelings in the VR
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".
Measured: immediately after the intervention (post-intervention)
Levels of difficulty
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".
Measured: immediately after the intervention (post-intervention)
Levels of interest
Two items will be used to measure the levels of difficulty. Items are "This game is very interesting" and "I like this game".
Measured: immediately after the intervention (post-intervention)
Intervention satisfaction
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.
Measured: immediately after the intervention (post-intervention and only in the last week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for YouthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvia CHEN, Ph.D., Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454851
- Sponsor's protocol ID
- HSEARS20240214005-01
- Status last verified
- May 2024
- First submitted
- 28 May 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Reality (VR) Intervention for Promoting Prosocial Behavior and Well-being in Youth Transitioning From Secondary to Tertiary Education: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06454851
- Acronym / sponsor ID
- HSEARS20240214005-01
- Conditions
- Youth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the present project is to develop a gamified prosocial VR intervention for youth transitioning from secondary to tertiary education, and to test the effectiveness of the gamified prosocial VR intervention for promoting prosocial behavior and well-being.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR Intervention group | Experimental | Behavioral: Prosocial VR interventionParticipants 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. |
| Waitlist control group | Sham comparator | Other: No interventionParticipants in the waitlist condition will be asked to continue their usual activity routines before their turn to receive the intervention. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 15-19
- Secondary 6 to college year 1
- Can read traditional Chinese and understand Cantonese
Key exclusion criteria (3 listed)
- History of photosensitive epilepsy
- Impairment of stereoscopic vision
- Balance problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prosocial VR interventionA 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. | Behavioural | VR Intervention group |
| No interventionThe waitlist control group will not receive the intervention during the study. | Other | Waitlist control group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Diary measures
Time frame: Daily monitoring for four weeks during the intervention
State prosocial behavior outcomes and well-being outcomes will be measured.
4 secondary outcomes
Feelings in the VR
Time frame: immediately after the intervention (post-intervention)
Levels of difficulty
Time frame: immediately after the intervention (post-intervention)
Levels of interest
Time frame: immediately after the intervention (post-intervention)
Intervention satisfaction
Time frame: immediately after the intervention (post-intervention and only in the last week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvia CHEN, Ph.D. principal investigator
The Hong Kong Polytechnic University
Questions about this trial
What is this clinical trial studying?
A study testing Prosocial VR intervention in people with Youth, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Zhang (852-9423-3827, tao-t.zhang@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosocial behavior (time frame: Baseline (pre-intervention); immediately after the intervention (post-intervention); 1 month after intervention (follow-up)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.