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Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents (smokeSCREEN)

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ClinicalTrials.gov Identifier: NCT03107936
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
The goal of the proposed research is multi-step, through a series of sub-studies that build on each other as part of a comprehensive line of investigation into the use of interactive mobile games as interventions and/or data collection tools around smoking and tobacco products in teens.

Condition or disease Intervention/treatment Phase
Smoking Behavioral: game prototype Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Actual Study Start Date : January 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
No Intervention: Sub Study 1- Focus Group
40 adolescents, aged 11-14, recruited from partner programs, who have never tried smoking will conduct focus groups.
Experimental: Sub Study 2
30 adolescents, aged 11-14, who have never tried smoking will play the adapted game
Behavioral: game prototype
PlayForward: smokeSCREEN videogame to focus on smoking and use of tobacco products (electronic cigarettes (e-cigarettes) and flavored tobacco products) prevention in teens.

No Intervention: Sub Study 3- Focus group
10 girls and boys, aged 11-14, will participate in the focus groups to focus the game on e-cigarettes and other tobacco product use.
Experimental: Sub Study 1- Test Game
30 girls and boys, aged 11-14, will test the first phase of the app.
Behavioral: game prototype
PlayForward: smokeSCREEN videogame to focus on smoking and use of tobacco products (electronic cigarettes (e-cigarettes) and flavored tobacco products) prevention in teens.

Experimental: Sub Study 3- Test Game
40 girls and boys, aged 11-14, will participate in the pilot test of the game with a focus on e-cigarettes and other tobacco product use.
Behavioral: game prototype
PlayForward: smokeSCREEN videogame to focus on smoking and use of tobacco products (electronic cigarettes (e-cigarettes) and flavored tobacco products) prevention in teens.




Primary Outcome Measures :
  1. Intention to initiate smoking [ Time Frame: 12 weeks ]
    The specific questions that will be used to assess "change of intention to initiate smoking" are adapted from the Global Youth Tobacco Survey. The questions incorporate a Likert-type scale, in which participants are asked if they plan to use different tobacco products in the next year and if they would accept offers of different tobacco products from friends and/or family members. For all these questions, participants can choose from four possible responses: definitely not, probably not, probably yes, and definitely yes.

  2. Intention to initiate smoking [ Time Frame: Baseline ]
    The specific questions that will be used to assess "change of intention to initiate smoking" are adapted from the Global Youth Tobacco Survey. The questions incorporate a Likert-type scale, in which participants are asked if they plan to use different tobacco products in the next year and if they would accept offers of different tobacco products from friends and/or family members. For all these questions, participants can choose from four possible responses: definitely not, probably not, probably yes, and definitely yes.


Secondary Outcome Measures :
  1. Change in Self-efficacy for refusing offers of cigarettes [ Time Frame: 12 weeks ]
    Research assistants will individually administer in-person questionnaires to participants at baseline and again at 12-weeks. The specific questions that will be used to assess "change in self-efficacy for refusing offers of cigarettes" are adapted from the PlayForward Self-Efficacy Assessment (Fiellin et al., 2016). The questions incorporate a Likert-type scale, in which participants are asked how sure they are they could refuse offers for cigarettes, and can choose from four possible responses: not sure at all, not very sure, pretty sure, definitely sure. This assessment was originally developed using Carpenter et al.'s "Development of a Drug Use Resistance Self-efficacy (DURSE) Scale (2009).

  2. Changes in percieved social norms related to smoking [ Time Frame: 12 weeks ]
    Research assistants will individually administer in-person questionnaires to participants at baseline and again at 12-weeks. The specific questions that will be used to assess "changes in perceived social norms related to smoking" are adapted from "Psychosocial Factors Associated with Adolescent Electronic Cigarette and Cigarette Use" (Barrington-Trimis et al, 2015) and the Global Youth Tobacco Survey. The questions either take the form of "How many of your 4 closest friends use these products?" or incorporate a Likert-type scale, in which participants indicate how their friends would act towards them if they used these products, choosing from four possible responses: very unfriendly, unfriendly, friendly, or very friendly.

  3. Changes in attitudes about smoking [ Time Frame: 12 weeks ]
    Research assistants will individually administer in-person questionnaires to participants at baseline and again at 12-weeks. The specific questions that will be used to assess "changes in attitudes about smoking" are adapted from the Global Youth Tobacco Survey and the National Youth Tobacco Survey. The questions incorporate Likert-type scales. For example, for some of these questions, participants indicate how harmful they believe smoking products are, choosing from four possible responses: no harm, little harm, some h arm, a lot of harm. In other questions, participants indicate where they stand on statements about these products, choosing from four possible responses: strongly agree, agree, disagree, or strongly agree.

  4. Changes in smoking behavior [ Time Frame: 12 weeks ]

    Smoking behavior will be defined as the quantity and frequency with which an individual uses cigarettes, cigars, cigarillos, little cigars, any electronic cigarette products, or any other form of a tobacco product.

    Research assistants will individually administer in-person questionnaires to participants at baseline and again at 12-weeks. The specific questions that will be used to assess "changes in smoking behavior" are adapted from questions on the National Youth Tobacco Survey. Participants are asked to indicate which, if any, products they've used in their lives, in the past 30 days, how often, and in what quantity.




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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • be 11-14 years of age
  • for sub study 1 and 2, respondents must not have smoked
  • for sub study 3, smoking is ok
  • must be able and willing to sit with a smartphone or tabled computer for 60 minutes per session to play the game

Exclusion Criteria:

  • up to the discretion of the study team

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107936


Contacts
Contact: Tyra Pendergrass 203-737-6101 tyra.pendergrass@yale.edu

Locations
United States, Connecticut
Hamden Youth Center Recruiting
Hamden, Connecticut, United States, 06517
Contact: Christine Buechele    203-288-5333    CBuechele@Hamden.com   
Leadership, Education, and Athletics Partnership (LEAP) Inc. Recruiting
New Haven, Connecticut, United States, 06511
Contact: Elvert Eden    203-773-0770    eeden@leapforkids.org   
Yale New Haven Hospital Not yet recruiting
New Haven, Connecticut, United States, 06511
Contact: Lynn Fiellin, MD    203-737-3347    lynn.fiellin@yale.edu   
Farnam Neighborhood House Not yet recruiting
New Haven, Connecticut, United States, 06513
Contact: Elizabeth Gamberdella    203-562-9194    egambardella@farnamcommunity.org   
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Lynn E. Fiellin, MD Yale University

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03107936     History of Changes
Other Study ID Numbers: 1401013293
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No