NCT05290103

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
781

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2022

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

March 10, 2022

Last Update Submit

May 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    At baseline, at 2 weeks, and at 3 months

  • Change in motivation to decline tobacco use in the future

    At baseline, at 2 weeks, and at 3 months

Study Arms (2)

Game intervention

EXPERIMENTAL

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

No intervention

NO INTERVENTION

The participants in this arm will receive no intervention.

Interventions

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.

Game intervention

Eligibility Criteria

Age10 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary schools (n=15)

Nine Cities, Finland

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral candidate

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 22, 2022

Study Start

February 1, 2022

Primary Completion

June 5, 2022

Study Completion

June 5, 2022

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations