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

Sponsor

University of Turku (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05290103

Collaborator

(none)

750

Enrollment

Location

Arms

2.9

Anticipated Duration (Months)

256.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Self Efficacy Smoking	Behavioral: Game intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

750 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Game intervention 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 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.
No Intervention: No intervention The participants in this arm will receive no intervention.

Arm

Intervention/Treatment

Experimental: Game intervention

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

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.

No Intervention: No intervention

The participants in this arm will receive no intervention.

Outcome Measures

Primary Outcome Measures

Change in smoking refusal self-efficacy [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 Outcome Measures

Change in sources of refusal self-efficacy related to tobacco use [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.
Change in motivation to decline tobacco use in the future [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Primary schools (n=15)	Nine Cities		Finland

Sponsors and Collaborators

University of Turku

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johanna Nyman, Doctoral candidate, University of Turku

ClinicalTrials.gov Identifier:

NCT05290103

Other Study ID Numbers:

PEANS2022

First Posted:

Mar 22, 2022

Last Update Posted:

Mar 22, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 22, 2022