Promoting Early Adolescent Non-smoking With a Game Intervention Supporting Self-efficacy
1 other identifier
interventional
781
1 country
1
Brief Summary
This intervention study evaluates the effectiveness of a digital game intervention supporting smoking refusal self-efficacy among early adolescents (10-13 y). The participants are randomly allocated to two groups: the experimental group that receives the digital game intervention, and the control group that receives no intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2022
Shorter than P25 for not_applicable
1 active site
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
Study Start
First participant enrolled
February 1, 2022
CompletedFirst Submitted
Initial submission to the registry
March 10, 2022
CompletedFirst Posted
Study publicly available on registry
March 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2022
CompletedMay 10, 2023
May 1, 2023
4 months
March 10, 2022
May 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in smoking refusal self-efficacy
Assessed with a smoking refusal self-efficacy scale (scores 6-24; higher scores indicate stronger smoking refusal self-efficacy).
At baseline, at 2 weeks, and at 3 months
Secondary Outcomes (2)
Change in sources of refusal self-efficacy related to tobacco use
At baseline, at 2 weeks, and at 3 months
Change in motivation to decline tobacco use in the future
At baseline, at 2 weeks, and at 3 months
Study Arms (2)
Game intervention
EXPERIMENTALParticipants in this arm will receive the game intervention including 15-30 minutes of digital health game playing at school and 2 weeks of free usage of the game during free time and a 30-minute debriefing session with a researcher.
No intervention
NO INTERVENTIONThe participants in this arm will receive no intervention.
Interventions
Game intervention consists of 15-30 minutes digital health game playing at school and 2 weeks free usage of the digital health game during free time. In addition, after the 2 weeks period of game playing, 30-minute debriefing sessions with a research are held. The digital health game includes visualized elements with sound effects that aim at increasing understanding about the consequences of tobacco product use and supporting refusal skills. The health game includes different mini-games and also textual information. The debriefing sessions with a researcher include small group and group discussions about the themes presented in the game. A researcher leads and teachers facilitate the discussions. The debriefing sessions aim to connect the game experience with daily life situations.
Eligibility Criteria
You may qualify if:
- Goes to school at 4th, 5th, or 6th grade
- Sufficient skills in Finnish or Swedish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Primary schools (n=15)
Nine Cities, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctoral candidate
Study Record Dates
First Submitted
March 10, 2022
First Posted
March 22, 2022
Study Start
February 1, 2022
Primary Completion
June 5, 2022
Study Completion
June 5, 2022
Last Updated
May 10, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share