NCT05477342

Brief Summary

Adolescents are at risk for tobacco use due to factors such as impulsivity, poor perception, desire to prove themselves, and insufficient neurological development. The Center of Disease (CDC) warns that if smoking continues at the current rate among young people, young people younger than 18 will die prematurely from a smoking-related disease The aim of this study was to comparison the effect of a board game and tobacco cessation education on reducing nicotine addiction in adolescents. A single-blind randomized controlled trial was used to evaluation the effect s of the different interventions on tobacco cessation. The 12 week interventions included: 1) Board Game (BG) and 2) Tobacco Cessation Education (TCE) developed based on Transtheoretical Model and 3) combined use of these two interventions (Cİ). All interventions were compared to Control Group(CG). "Fagerström Test for Nicotine Dependence (FNTD)" were used to collect data at baseline, at 8.week and at 12.week the intervention. "Assessment Of Stage Of Change Form (ASCF)" were used to collect data at baseline and at the end of each intervention (every two weeks one). Participants were consisted of students studying at a high school in Eskisehir in Turkey. In order to form the intervention groups, permission was obtained from the school principal and teacher of each class, and the students were informed about the purpose of the study and the participation criteria. It was done in information classes. Recruitment began in October 2018 and end in January 2019. Students who wanted to participate in the study were asked to send a short message to the investigator's private phone number. An automated response with a hyperlink was sent to a web page where information about the study was presented and students were asked to give informed consent at the push of a button. Students who agreed to participate were enrolled in a web-based questionnaire for egilibility screening.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2018

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

1 month

First QC Date

April 3, 2022

Last Update Submit

July 25, 2022

Conditions

Keywords

adolescentboard gamechange of stagedependencegamificationnicotine

Outcome Measures

Primary Outcomes (2)

  • Fagerstrom test for nicotine dependence (FTND)

    The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the that played both the board game and received tobacco cessation education was more successful in education tobacco than the group that played only the board game and received only smoking cessation education.

    Three month

  • Stages of Change Scale (SCS):

    There is no scoring in the scale. "Have you stopped smoking?" The stage of change is determined according to the answers given by the individual to the question. The response of the individual "I don't plan to quit in the next 6 months" to precontemplation stage , "I intend to quit within 6 months" to contemplation stage, "I intend to quit within 30 days" to preparation stage , "I quit less than 6 months ago" to action stage, "to longer than 6 months" I quit a while ago" indicates that it is in the maintenance stage

    Three month

Study Arms (4)

İntervention 1

EXPERIMENTAL

Experimental 1 - Board Game Group: Board game group played only board game.

Behavioral: Board Game

İntervention 2

EXPERIMENTAL

Experimental 2 - Tobacco Cessation Education Group: The Tobacco Cessation Education Group received only education according to the stages of change model.

Behavioral: Tobacco Cesseation Education

İntervention 3

EXPERIMENTAL

Experimental 3 - Combined intervention Group:Combined intervention group received both board game and tobacco cessation education.

Behavioral: Combined İntervention

Control Group

NO INTERVENTION

No intervention was made in the control group.

Interventions

Board GameBEHAVIORAL

The BG group that will play the game were divided into four groups with five or six participants in each group. (GP (Game Player) GP1- GP 2- GP 3- GP 4.

İntervention 1

The TCE group were divided three group that E1 (Precontemplation) -E2 (Contemplation)-E3 (Preparation) according to the thinking stages scale.

İntervention 2

The CI group was divided into five groups for play that will play the game were divided into four groups with five or six participants in each group. (GP (Game Player)GP 5- GP 6- GP 7- GP 8- GP 9). The CI group was divided into three groups for education that E4 (Precontemplation) -E5 (Contemplation)-E6 (Preparation) according to the thinking stages scale.

İntervention 3

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Studying at Odunpazarı Mustafa Kemal Atatürk Vocational and Technical Anatolian High School,
  • Having at least one cigarette a day,
  • Volunteering to participate in the research

You may not qualify if:

  • Not smoker
  • Not wanting to participate in research
  • Have a mental health disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Remziye CAN

Tepebaşı, Eski̇şehi̇r, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tobacco Use DisorderTobacco Use CessationSmoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Transtheoretical Model
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 3, 2022

First Posted

July 28, 2022

Study Start

September 3, 2018

Primary Completion

October 3, 2018

Study Completion

December 5, 2018

Last Updated

July 28, 2022

Record last verified: 2022-07

Locations