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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05290103
• Other study ID #: PEANS2022
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: June 5, 2022

Study information

• Verified date: May 2023
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 781
• Est. completion date: June 5, 2022
• Est. primary completion date: June 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 13 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Self Efficacy
• Smoking

Intervention

Behavioral:
• Game intervention
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.

Locations

Country	Name	City	State
Finland	Primary schools (n=15)	Nine Cities

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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