Promoting Early Adolescent Non-smoking With a Game Intervention Supporting Self-efficacy

Study Overview
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Brief Summary
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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.

Official Title
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Promoting Early Adolescent Non-smoking With a Game Intervention Supporting Self-efficacy

Conditions
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Smoking, Self Efficacy

Intervention / Treatment
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* Behavioral: Game intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Goes to school at 4th, 5th, or 6th grade Sufficient skills in Finnish or Swedish Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Game intervention<br>Participants 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. | Behavioral: Game intervention<br>* 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.<br>|
| No Intervention: No intervention<br>The participants in this arm will receive no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sources of refusal self-efficacy related to tobacco use | Subscales for cigarette use (7 items) and snus use (7 items). Both are assessed with a 4-point Likert-scale questionnaire. | At baseline, at 2 weeks, and at 3 months | 
| Change in motivation to decline tobacco use in the future | Subscales for cigarette use and snus use. Both are assessed with a 4-point Likert-scale questionnaire (scores 1-4, lower scores indicate stonger motivation to decline tobacco use in future). | At baseline, at 2 weeks, and at 3 months |