Self EfficacyNCT05290103
Promoting Early Adolescent Non-smoking With a Game Intervention Supporting Self-efficacy
A study testing Game intervention in people with Self Efficacy and Smoking, run by University of Turku at 1 site in Finland.
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… Read more about this study
- Who is it for?
- Ages 10 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Self Efficacy, Smoking
- What is being tested?
- Game intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 781 participants
- Where
- 1 siteFinland
- Study dates
- 1 Feb 2022to 5 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Goes to school at 4th, 5th, or 6th grade
- Sufficient skills in Finnish or Swedish
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Self Efficacy, Smoking
- Being tested
- Game intervention
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Game intervention |
| No intervention | No intervention | The participants in this arm will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline, at 2 weeks, and at 3 months
Secondary outcomes (2)
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.
Measured: At baseline, at 2 weeks, and at 3 months
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).
Measured: At baseline, at 2 weeks, and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Feb 2022
- Primary completion5 Jun 2022
- Study completion5 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self EfficacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 781 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johanna Nyman, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290103
- Sponsor's protocol ID
- PEANS2022
- Status last verified
- May 2023
- First submitted
- 10 Mar 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Early Adolescent Non-smoking With a Game Intervention Supporting Self-efficacy
- ClinicalTrials.gov ID
- NCT05290103
- Acronym / sponsor ID
- PEANS2022
- Conditions
- Self Efficacy, Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 781 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 5 Jun 2022 (actual)
- Study completion
- 5 Jun 2022 (actual)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Game intervention | Experimental | Behavioral: Game interventionParticipants 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. |
| No intervention | No intervention | –The participants in this arm will receive no intervention. |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Goes to school at 4th, 5th, or 6th grade
- Sufficient skills in Finnish or Swedish
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game interventionGame 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. | Behavioural | Game intervention |
Primary outcome
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).
2 secondary outcomes
Change in sources of refusal self-efficacy related to tobacco use
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game intervention in people with Self Efficacy and Smoking, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in smoking refusal self-efficacy (time frame: At baseline, at 2 weeks, and at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.