NCT07501572

Brief Summary

This study evaluates the effectiveness of a robot-assisted immersive escape room intervention for tobacco harm prevention among upper-grade elementary school students. A total of 200 fifth- and sixth-grade students from elementary schools in New Taipei City, Taiwan, will participate in this quasi-experimental, parallel-group design. Participants will be allocated non-randomly to either the experimental group, which receives the robot-assisted immersive escape room intervention, or the active comparator group, which receives standard classroom-based tobacco harm prevention education. In the experimental arm, an educational robot named "Anti-Smoking Kebbi" serves as a non-player character (NPC) to facilitate human-robot interaction through puzzle-solving and scenario-based learning focused on e-cigarette and tobacco hazards. Both groups will be assessed using validated questionnaires at three time points: baseline (pre-intervention), immediately post-intervention, and 1-month follow-up. Primary and secondary outcome measures will include changes in tobacco harm knowledge, health beliefs, smoking refusal self-efficacy, extended expectation confirmation, learning engagement, behavioral intention, and advocacy intention.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

March 5, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

March 30, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

March 5, 2026

Last Update Submit

March 24, 2026

Conditions

Keywords

Educational RobotHuman-Robot InteractionEscape Room LearningTobacco PreventionE-cigarette Education

Outcome Measures

Primary Outcomes (1)

  • Change in Tobacco Harm Knowledge

    This study adapted the Tobacco Harm Knowledge Scale from the Youth Smoking Behavior Survey Questionnaire (Health Promotion Administration, 2021). The scale covers e-cigarette components, legal regulations, and health impacts to assess students' understanding of basic tobacco knowledge gained from the curriculum. The 10-item scale uses objective scoring (1 point for correct answers, 0 points for incorrect or "don't know" responses) and demonstrates acceptable internal consistency (Cronbach's Alpha = 0.66).

    Baseline (pre-intervention), immediately post-intervention, and 1-month follow-up

Secondary Outcomes (6)

  • Change in Health Beliefs About Tobacco Use

    Baseline, immediately post-intervention, and 1-month follow-up.

  • Change in Smoking Refusal Self-Efficacy

    Baseline, immediately post-intervention, and 1-month follow-up.

  • Extended Expectation Confirmation

    Baseline, immediately post-intervention, and 1-month follow-up.

  • Learning Engagement

    Immediately post-intervention.

  • Behavioral Intention

    Immediately post-intervention.

  • +1 more secondary outcomes

Study Arms (2)

Robot-Assisted Immersive Escape Room Intervention

EXPERIMENTAL

Students participate in a 60-minute robot-assisted immersive escape room intervention designed to prevent e-cigarette use. The program uses the "Anti-Smoking Kebbi" robot as a non-player character (NPC) to guide students through interactive puzzles and scenario-based tasks that teach the health risks of e-cigarette use and strategies for tobacco prevention.

Behavioral: Robot-assisted Immersive Escape Room Game

Traditional Tobacco Harm Prevention Education

ACTIVE COMPARATOR

Students receive a 60-minute traditional health education session on tobacco and e-cigarette harms delivered by trained teachers using lectures, slides, and classroom discussion, consistent with standard school-based health education practices.

Behavioral: Traditional Tobacco Harm Prevention Education

Interventions

Students participate in a 60-minute robot-assisted immersive escape room designed to prevent e-cigarette use. The session is facilitated by the educational robot "Anti-Smoking Kebbi," which acts as a non-player character (NPC) guiding students through interactive puzzles and scenario-based challenges. The activity integrates human-robot interaction and gamified learning strategies to teach the health risks of e-cigarette use and tobacco prevention concepts. The intervention is delivered once in a classroom setting.

Robot-Assisted Immersive Escape Room Intervention

Students receive a 60-minute standard classroom-based health education session on tobacco and e-cigarette harms delivered by trained teachers. The session uses lectures, presentation slides, and guided discussion to introduce the health risks of tobacco and e-cigarette use and strategies for prevention. The intervention is delivered once in a classroom setting.

Traditional Tobacco Harm Prevention Education

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Fifth or sixth grade students from elementary schools in New Taipei City
  • Age 10-12 years
  • Written consent from parent/guardian
  • Verbal assent from student
  • Able to understand Chinese questionnaires

You may not qualify if:

  • Prior participation in tobacco harm education trials
  • History of tobacco-related allergies
  • Unable to complete questionnaires
  • Parental refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shuangfeng Elementary School, New Taipei City

New Taipei City, Xindian District, 231040, Taiwan

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jong-Long Guo

    National Taiwan Normal University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
"None (Open Label): No masking due to the distinct nature of interventions (robot-assisted immersive escape room vs. traditional health education). Both participants and study personnel are aware of group allocation in this quasi-experimental design."
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A quasi-experimental parallel-group study conducted in six elementary schools in New Taipei City, Taiwan. Three schools were assigned to the experimental group receiving a robot-assisted immersive escape room intervention for e-cigarette harm prevention, while three matched schools served as the control group receiving standard health education. Pretest, posttest, and one-month follow-up assessments were conducted using structured questionnaires.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2026

First Posted

March 30, 2026

Study Start

April 1, 2026

Primary Completion

May 1, 2026

Study Completion

June 1, 2026

Last Updated

March 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

No IPD sharing planned due to small sample size (n=200 children), privacy concerns with pediatric participants, and limited resources for data repository management.

Locations