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

May 9, 2023 updated by: Johanna Nyman, University of Turku
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

781

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Nine Cities, Finland
        • Primary schools (n=15)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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.
At baseline, at 2 weeks, and at 3 months
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).
At baseline, at 2 weeks, and at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

June 5, 2022

Study Completion (Actual)

June 5, 2022

Study Registration Dates

First Submitted

March 10, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • PEANS2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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