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Completed

NCT Number: NCT05290103

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

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.

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Key information

Conditions

Self Efficacy Behavior Smoking

Age range

10 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primary schools (n=15)

Nine Cities, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Goes to school at 4th, 5th, or 6th grade
  • Sufficient skills in Finnish or Swedish

Exclusion criteria

-

Treatment and study plan

Game intervention

Behavioral

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.

Primary outcomes

  1. Change in smoking refusal self-efficacy

    Time frame: At baseline, at 2 weeks, and at 3 months

    Assessed with a smoking refusal self-efficacy scale (scores 6-24; higher scores indicate stronger smoking refusal self-efficacy).

Secondary outcomes

  1. Change in sources of refusal self-efficacy related to tobacco use

    Time frame: At baseline, at 2 weeks, and at 3 months

    Subscales for cigarette use (7 items) and snus use (7 items). Both are assessed with a 4-point Likert-scale questionnaire.

  2. Change in motivation to decline tobacco use in the future

    Time frame: At baseline, at 2 weeks, and at 3 months

    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).

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2022
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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