The Real Cost Smokeless: Wave 2 In-depth Interviews Designed to Prevent Rural Youth Tobacco Use

OMB# 0910-0796

Exp. 06/30/2018

The Real Cost Smokeless: Wave 2 In-depth Interviews Designed to Prevent Rural Youth Tobacco Use

SCREENER

OVERVIEW

In-depth interview participants will be recruited during lunch, in the hallways between classes, or at another time designated by the local principal. Between 2-4 recruiters per school will be on campus to administer the electronic screener via tablet and provide instructions.

Before recruiting commences, all recruiters will attend training to ensure the screening procedures are administered consistently.

Rationale/Justification for Screener Items:

Item(s)	Rationale/Justification
1	Initial agreement to participate in the research study
Termination Point for students who do not wish to participate.
2-3	Verify age. Ensure all participants are between the ages of 12-17 and will not turn 18 that week. Use age and grade information to assign participants to groups. Middle school groups (6th-8th grades) will have 12 and 13 year olds and high school groups (9th-12th grade) will have 15, 16, and 17 year olds. We anticipate that some 14 year olds will be in 8th grade, and thus will be placed with their middle school peers. Other 14 year olds will be in 9th grade, and thus will be placed with their high school peers.
4	Verify gender. Ensure all participants are male.
5a-b	Verify race/ethnicity.
6-7	Distractor questions.
Termination Point for students who do not meet criteria in 2-4 or skipped 5a-b.
8a 9a 10a-e	Verify smokeless tobacco status. Identify students who are at-risk experimenters, and established users. Exclude students who are closed to using smokeless tobacco or former users.
Termination Point for students who do not meet criteria in 8a, 9a, and 10a-e.
8b-f 9b-f 11a-d 12a-d 13a-d 14a-d 15a-c	Verify other tobacco products status as supplement to smokeless tobacco status
16-17	Obtain student name, 1st period class (obtained for scheduling purposes only)
18	Student willing to be audio recorded during interview as part of this study
19	Student agreement to either return a signed Parent/Guardian consent form to study staff or deliver a Parent/Guardian notification if invited to participate in the study.
Termination Point for eligible students who are not willing to comply with 18 or 19.

RECRUITER SCRIPT

Hi! I’m [NAME]. I work for a research company Fors Marsh Group [point to logo on nametag] and we are at your school this week conducting in-depth interviews. The in-depth interviews will take place in school during the regular school day. In-school interviews will last up to 90 minutes. In these in-depth interviews, we will ask you questions to learn more about you, local trends, lifestyles, and health-related behaviors. All you have to do is tell us what you think. There are no wrong answers – we just want your opinion

If you are interested, all you have to do now is answer a few questions on my tablet [clipboard] to see if you are eligible to participate. If you don’t want to participate, or if we determine that you are not eligible to participate, there are no consequences to you and it will have no effect on your grades or how you teachers or staff at your school think of you. It’s completely your choice, and we will not share any information you provide to us during the screening process or during the interview with your parent(s)/guardian(s), teachers, or anyone else outside of the research team.

Do you want to complete the questionnaire to see if you are eligible to participate? [If yes, continue. If no, thank and move on.]

Note- The screener will be programmed as an electronic survey that students will complete via tablet during the recruitment period. In some cases we may employ paper screeners should the need arise.

Please answer the following questions.

1. We will be conducting in-depth interviews over the next several days. Would you be interested in participating in our studies?

Yes CONTINUE to Q2

^{No thanks} TERMINATE

TERMINATION CRITERIA	Terminate if Q1= “No thanks”
TERMINATION LANGUAGE [shown on separate screen]	Thank you for your time. Please return this tablet to the study staff.

Programming Note: All the questions from 2 to 4B will be asked, even if participants screen out by question 2 or 3 in order to obscure the reason for screening out.

2. How old are you?

Under 12

12

13

14

15

16

17

18. _{or Over}

3. Will you turn 18 this Friday?

Yes TERMINATION

No

4. What is your gender?

Male

_Female

5a. Are you Hispanic or Latino?

Yes

_No

5b. Which of the following best describes your race? (Mark all that apply)

American Indian or Alaska Native

Asian

Black or African American

Native Hawaiian or Pacific Islander

White

TERMINATION CRITERIA	Terminate if Q2= “Under 12” or “18 or Over” Terminates if Q3 = “Yes” Terminate if Q4 = Female
TERMINATION LANGUAGE [shown on separate screen]	Thank you for your interest in participating in this study. Unfortunately, based on the responses you provided, you do not meet the specifications we are looking for to complete this study. Please return this tablet to the study staff.

_{6. During the past 7 days, did you drink a can, bottle, or glass of soda or pop, such as Coke, Pepsi, or Sprite? (Do not count diet soda or diet pop.)}

Yes CONTINUE TO Q7

No _{SKIP to Q8}

_[Programmer: ONLY ASK Q6 IF Q5=“Yes”]

_{7. During the past 7 days, how many times did you drink a can, bottle, or glass of soda or pop, such as Coke, Pepsi, or Sprite? Your best guess is fine. (Do not count diet soda or diet pop.)}

_{I did not drink soda or pop during the past 7 days}

_{1 to 3 times during the past 7 days}

_{4 to 6 times during the past 7 days}

_{1 time per day}

_{2 times per day}

_{3 times per day}

_{4 times or more per day}

8. Have you ever tried any of the following?

//Randomize 7A-7F//

8A. Smokeless tobacco (such as snus pouches, moist snuff, dip, spit, or chewing tobacco)	[ ] Yes	[ ] No
8B. Cigars – even one or two puffs	[ ] Yes	[ ] No
8C. Cigarillos or little cigars – even one or two puffs (for example, Black & Mild or Swisher Sweets)	[ ] Yes	[ ] No
8D. Electronic cigarettes or e-cigarettes – even one or two puffs (for example, e-cigs, vape pens, personal vaporizers, mods, e-cigars, e-pipes, e-hookahs, hookah pens)	[ ] Yes	[ ] No
8E. Tobacco from a hookah or water pipe – even one or two puffs	[ ] Yes	[ ] No
8F. Cigarettes – even one or two puffs	[ ] Yes	[ ] No

[Programmer: ONLY ASK Q9A IF Q8A=“Yes”]

9A. How many times have you used chewing tobacco, snuff or dip in your entire lifetime?

Your best guess is fine. Would you say…

Less than 20 times

20 times, but less than 50 times

50 times, but less than 100 times

More than 100 times

[Programmer: ONLY ASK Q9B IF Q8B=“Yes”]

9B. How many times have you used a cigar in your entire lifetime?

Your best guess is fine. Would you say…

Less than 20 times

20 times, but less than 50 times

50 times, but less than 100 times

More than 100 times

[Programmer: ONLY ASK Q9C IF Q8C=“Yes”]

9C. How many times have you used a cigarillo or little cigar in your entire lifetime?

Your best guess is fine. Would you say…

Less than 20 times

20 times, but less than 50 times

50 times, but less than 100 times

More than 100 times

[Programmer: ONLY ASK Q9D IF Q8D=“Yes”]

9D. How many times have you used an electronic cigarette or e-cigarette in your entire lifetime?

Your best guess is fine. Would you say…

Less than 20 times

20 times, but less than 50 times

50 times, but less than 100 times

More than 100 times

[Programmer: ONLY ASK Q9E IF Q8E=“Yes”]

9E. How many times have you used tobacco from a hookah or water pipe in your entire lifetime?

Your best guess is fine. Would you say…

Less than 20 times

20 times, but less than 50 times

50 times, but less than 100 times

More than 100 times

[Programmer: ONLY ASK Q9F IF Q8F=“Yes”]

9F. About how many cigarettes have you smoked in your entire life? Your best guess is fine. Would you say…

1 or more puffs but never a whole cigarette

1 cigarette

2 to 5 cigarettes

6 to 15 cigarettes (about 1/2 a pack total)

16 to 25 cigarettes (about 1 pack total)

26 to 99 cigarettes (more than 1 pack, but less than 5 packs)

100 or more cigarettes (5 or more packs)

[Programmer: ONLY ASK Q10A-Q9D IF Q8A=“No”]

_{10A. Do you think you will use chewing tobacco, snuff or dip in the future?}

_{Definitely yes}

_{Probably yes}

_{Probably not}

_{Definitely not}

10B. Do you think you will use chewing tobacco, snuff or dip in the next year? Would you say…

Definitely yes

Probably yes

Probably not

Definitely not

10C. If one of your best friends were to offer you chewing tobacco, snuff or dip, would you use it? Would you say…

Definitely yes

Probably yes

Probably not

Definitely not

10D. Have you ever been curious about using smokeless tobacco?

Very curious

Somewhat curious

A little curious

Not at all curious

[Programmer: ONLY ASK Q10E IF Q9A=“More than 100 times”]

10E. Do you currently use smokeless tobacco? ¹

Not at all TERMINATE

Some days

Every day

TERMINATION CRITERIA	Terminate if: Q8A=“No” and Q10A/Q10B/Q10C=“Definitely Not” and Q10D= “Not at all curious” Q8A= “More than 100 times” and Q9E= “Not at all”
TERMINATION LANGUAGE [shown on separate screen]	Thank you for your interest in participating in this study. Unfortunately, based on the responses you provided, you do not meet the specifications we are looking for to complete this study. Please return this tablet to the study staff.

[Programmer: ONLY ASK Q11A-Q11D IF Q8B=“No”]

_{11A. Do you think you will use a cigar in the future?}

_{Definitely yes}

_{Probably yes}

_{Probably not}

_{Definitely not}

11B. Do you think you will use a cigar in the next year? Would you say…

Definitely yes

Probably yes

Probably not

Definitely not

11C. If one of your best friends were to offer you a cigar, would you use it? Would you say…

Definitely yes

Probably yes

Probably not

Definitely not

11D. Have you ever been curious about using a cigar?

Very curious

Somewhat curious

A little curious

Not at all curious

[Programmer: ONLY ASK Q12A-Q12D IF Q8C=“No”]

_{12A. Do you think you will use a cigarillo or little cigar in the future?}

_{Definitely yes}

_{Probably yes}

_{Probably not}

_{Definitely not}

12B. Do you think you will use a cigarillo or little cigar in the next year? Would you say…

Definitely yes

Probably yes

Probably not

Definitely not

12C. If one of your best friends were to offer you a cigarillo or little cigar, would you use it? Would you say…

Definitely yes

Probably yes

Probably not

Definitely not

12D. Have you ever been curious about using a cigarillo or little cigar?

Very curious

Somewhat curious

A little curious

Not at all curious

[Programmer: ONLY ASK Q13A-Q13D IF Q8D=“No”]

_{13A. Do you think you will use an electronic cigarette or e-cigarette in the future?}

_{Definitely yes}

_{Probably yes}

_{Probably not}

_{Definitely not}

13B. Do you think you will use _{an electronic cigarette or e-cigarette} in the next year?

Would you say…

Definitely yes

Probably yes

Probably not

Definitely not

13C. If one of your best friends were to offer you an electronic cigarette or e-cigarette, would you use it? Would you say…

Definitely yes

Probably yes

Probably not

Definitely not

13D. Have you ever been curious about using _{an electronic cigarette or e-cigarette}?

Very curious

Somewhat curious

A little curious

Not at all curious

[Programmer: ONLY ASK Q14A-Q14D IF Q8E=“No”]

_{14A. Do you think you will use tobacco from a hookah or water pipe in the future?}

_{Definitely yes}

_{Probably yes}

_{Probably not}

_{Definitely not}

14B. Do you think you will use _{tobacco from a hookah or water pipe} in the next year?

Would you say…

Definitely yes

Probably yes

Probably not

Definitely not

14C. If one of your best friends were to offer you _{tobacco from a hookah or water pipe}, would you use it? Would you say…

Definitely yes

Probably yes

Probably not

Definitely not

14D. Have you ever been curious about using _{tobacco from a hookah or water pipe}?

Very curious

Somewhat curious

A little curious

Not at all curious

[Programmer: ONLY ASK Q15A-Q15C IF Q8F=“No”]

15A. Do you think you will try a cigarette soon?

Definitely yes

Probably yes

Probably not

Definitely not

15B. Do you think you will smoke a cigarette at any time in the next year? Would you say…

Definitely yes

Probably yes

Probably not

Definitely not

15C. If one of your best friends were to offer you a cigarette, would you smoke it? Would you say…

Definitely yes

Probably yes

Probably not

Definitely not

Other Tobacco Product (OTP) Usage Status To be used in prioritizing selection of participants who are at-risk or experimenting with OTPs
Product	At-Risk	Experimenter
Cigars	Q8B = NO AND 11A-D = “Definitely yes”, “Probably yes”, or “Probably not”	Q8B = YES AND Q9B< 100 times
Cigarillos	Q8C = NO AND 12A-D = “Definitely yes”, “Probably yes”, or “Probably not”	Q8C = YES AND Q9C< 100 times
E-Cigarette	Q8D = NO AND 13A-D = “Definitely yes”, “Probably yes”, or “Probably not”	Q8D = YES AND Q9D< 100 times
Hookah/Water Pipe	Q8E = NO AND 14-D = “Definitely yes”, “Probably yes”, or “Probably not”	Q8E = YES AND Q9E< 100 times
Cigarettes	Q8F = NO AND 15A-C = “Definitely yes”, “Probably yes”, or “Probably not”	Q8F = YES AND Q9F< 100 or more cigarettes

Thanks! Based on the responses you provided, you meet the specifications for this study.

16. Please enter your first name and last initial (e.g., James M.):

17. Please enter the last name of your teacher for your homeroom class (e.g., Smith):

[Programmer: SHOW NEW SCREEN]

You are almost set!

_{18. If selected to participate in this study, we would like to audio record the interviews.}

_{Would you be willing to be audio recorded during an interview as part of this study?}

_Yes

_{No TERMINATE [see language above]}

19. If selected to participate in this study, you will need to either obtain permission from a parent/guardian to participate or notify your parent/guardian about this study before you participate. Tomorrow, if selected, you will receive a form to take home with study information. No personal information will be requested on the form. Do you agree to take home a form tomorrow when you get home from school?

Yes

^No _{TERMINATE [see language above]}

[Programmer: SHOW NEW SCREEN]

Thanks! If you are selected to participate in an in-depth interview, you will receive a paper copy of either the Parent/Guardian Permission Form or Parent/Guardian Notification, a form outlining details of the study as they relate to you, a reminder card with the scheduled date/time/location of your session.

At this time, please return this tablet to the study staff. A member of the research staff should hand you another sheet with some information on it about scheduling you for an interview session.

Paperwork Reduction Act Statement: The public reporting burden for this information collection has been estimated to average 15 minutes per response to complete the Screener (the time estimated to read and review). Send comments regarding this burden estimate or any other aspects of this information collection, including suggestions for reducing burden, to PRAStaff@fda.hhs.gov.

1 Behavioral Risk Factor Surveillance System (BRFSS)

5