NCT06454851

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

June 12, 2024

Status Verified

May 1, 2024

Enrollment Period

11 months

First QC Date

May 28, 2024

Last Update Submit

June 10, 2024

Conditions

Outcome Measures

Primary Outcomes (15)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Daily monitoring for four weeks during the intervention

Secondary Outcomes (4)

  • Feelings in the VR

    immediately after the intervention (post-intervention)

  • Levels of difficulty

    immediately after the intervention (post-intervention)

  • Levels of interest

    immediately after the intervention (post-intervention)

  • Intervention satisfaction

    immediately after the intervention (post-intervention and only in the last week)

Other Outcomes (1)

  • Socio-demographic variables

    Baseline (pre-intervention)

Study Arms (2)

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.

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.

Other: No intervention

Interventions

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.

VR Intervention group

The waitlist control group will not receive the intervention during the study.

Waitlist control group

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 15-19
  • Secondary 6 to college year 1
  • Can read traditional Chinese and understand Cantonese

You may not qualify if:

  • History of photosensitive epilepsy
  • Impairment of stereoscopic vision
  • Balance problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Sylvia CHEN, Ph.D.

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2024

First Posted

June 12, 2024

Study Start

June 1, 2024

Primary Completion

May 1, 2025

Study Completion

May 31, 2025

Last Updated

June 12, 2024

Record last verified: 2024-05