Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents (HPHCs) in Tobacco Products

OMB Control #0910-0796

6/30/18

RIHSC #

RTI/FDA HPHC Interviews
Screening Questionnaire

11-30-2016

Parent Introduction:

Hello, this is _____________ from [FACILITY NAME], a local market research firm. May I please speak to Mr. Ms. _____________?

(Hello, Mr./Ms. _________________this is _____________ from [FACILITY NAME], a local market research firm. We are working with RTI International, a nonprofit research organization, a research study about tobacco products. I want to assure you that we are not from a tobacco company or a company that sells quit-smoking aids. I would like to talk to you about a study we plan to conduct for the Food and Drug Administration. We are recruiting for an upcoming set of individual interviews in which participants will be asked to discuss their knowledge and beliefs related to cigarettes and smokeless tobacco. We believe it is particularly important to talk with teens about this issue. Can we speak to _______________ [teen’s name] to see if they are able to participate in the study? If they are able to participate, we will need you to sign a permission form prior to his/her participation in the study. If your child qualifies for the study, I will ask to speak to you again at the end of the call so that I can give you more information. Before I ask to speak with _______________ [teen’s name], I’d like you to ask them to go sit somewhere that’s quiet and private, where no one else can hear their answers.

IF PARENT QUESTIONS THE NEED FOR PRIVACY, SAY:

We have a rule that everyone who participates in our research is given the opportunity to answer questions in private, including children.

Adolescent Introduction:

Hello _____________________________, my name is __________________. I’m with [FACILITY NAME]. We’re working with RTI International, a nonprofit research organization, on a research study about tobacco products, and we’re interested in talking to teens about cigarette smoking and using smokeless tobacco.

We are holding a set of individual interviews on [DATES]. The interview starts at [TIME] and will last no longer than 60 minutes. In appreciation for your participation, you will be reimbursed for your time, effort, and travel expenses. Participation is completely voluntary, and your responses will be kept private to the extent allowable by law. The interviews will be audio recorded, and project team members may observe the discussion in person or by video stream. Would it be OK if I ask you a few questions now in order to see if you are eligible to participate? Your answers to these questions will also be kept private to the extent allowable by law.

[YES] Continue. Great! Please find a comfortable place where you like to sit, where it is quiet and you can talk by yourself and where you are the only person who can hear my questions and nobody else can hear your answers. Have you found a good place? (Do you want to take a minute to find a place where you can talk by yourself?)

[NO] THANK AND END CALL

Adult Introduction:

Hello, this is _____________ from [FACILITY NAME], a local market research firm. May I please speak to_____________?

(Hello, this is _____________ from [FACILITY NAME], a local market research firm.) We are working with RTI International, a nonprofit research organization on a research study about tobacco products, and would like to include your opinions. I want to assure you that we are not from a tobacco company or a company that sells quit-smoking aids.

We would like to interview individuals on [DATE] about specific tobacco products. The interview will start at [TIME] and will take 60 minutes. For study purposes, the interviews will be audio recorded, and project team members may observe the discussion in person or by video stream.

In appreciation for your participation, you will be reimbursed for your time and effort. Participation in the interview is completely voluntary and your responses will be kept private to the fullest extent allowed by law. Would it be OK if I ask you a few questions now in order to see if you are eligible for the study?

Yes – Continue.

No – Thank and end call.

Q1. What is your current age? _______

<14 - Terminate

14-17 - Continue for adolescent interviews

18 and older - Continue for adult interviews

Q2. On a scale of 1-5, how comfortable are you understanding and speaking English? 1 is very uncomfortable and 5 is very comfortable. ______________

[Terminate if 3 or lower]

Q3. Do you currently smoke cigarettes?

Yes

(if yes response) How often:

Every day

Some days

No

Refused

Q4. Have you ever smoked cigarettes every day in the past?

Yes Continue

No Continue

Q5. Have you ever smoked at least 100 cigarettes in your entire life?

Yes Continue

No Continue

Q6. Do you currently use smokeless tobacco, sometimes called dip, chew, snuff, or snus every day, some days or not at all?

Every day

Some days

Not at all

Q7. Have you ever used smokeless tobacco, sometimes called dip, chew, snuff, or snus every day in the past?

Yes Continue to question 8

No Terminate if over 18 and also no to question 4, continue to question 8 if under 18

Q8. Do you currently use any other tobacco product?

Yes Continue, record answer

No Continue

If yes: Why types of tobacco products do you use?

1. Cigars, little cigars, or cigarillos

2. Pipes

3. Hookah

4. Dissolvable tobacco products

5. Electronic cigarettes (e-cigarettes)

6. Other: ___________________________

FOR <18 only

1. Susceptibility Questions

Q9. Do you think you will smoke a cigarette anytime during the next year?  Would you say…

Definitely yes

Probably yes

Probably not

Definitely not, or

REFUSED Terminate

Q10. Do you think you will try a cigarette soon? Would you say…

Definitely yes

Probably yes

Probably not

Definitely not, or

REFUSED Terminate

Q11. If one of your best friends offered you a cigarette, would you smoke it? Would you say…

Definitely yes

Probably yes

Probably not

Definitely not, or

REFUSED Terminate

Q12. Do you think you will use smokeless tobacco, sometimes called dip, chew, snuff, or snus anytime during the next year? Would you say…

Definitely yes

Probably yes

Probably not

Definitely not, or

REFUSED Terminate

Q13. Do you think you will try smokeless tobacco soon? Would you say…

Definitely yes

Probably yes

Probably not

Definitely not, or

REFUSED Terminate

Q14. If one of your best friends offered you smokeless tobacco would you use it? Would you say…

Definitely yes

Probably yes

Probably not

Definitely not, or

REFUSED Terminate

               

Note on Q9 - 14: If R says “Definitely Not” to any of this series and answered no to questions 3 and 6 they are ineligible

Remaining questions for ALL participants:

Q15. In the past 5 years, have you or any member of your household worked for any of the following? (Read list. If yes to any, thank the respondent and terminate.)

A tobacco or cigarette company

A public health or community organization involved in communicating the dangers of smoking or the benefits of quitting

A marketing, advertising, or public relations agency or department

The Federal Government (Read list. If yes to any, thank the respondent and terminate.)

The U.S. Food and Drug Administration (FDA)

The National Institutes of Health (NIH)

The Centers for Disease Control and Prevention (CDC)

The Substance Abuse and Mental Health Services Administration (SAMHSA)

The Centers for Medicare & Medicaid Services (CMS)

Q16. Have you or any member of your household ever lobbied on behalf of the tobacco industry?

Yes Thank the respondent and terminate.

No Continue.

Q17. Have you or any member of your household personally represented or worked on behalf of a tobacco company in connection with a tobacco lawsuit?

Yes Thank the respondent and terminate.

No Continue.

Q18. Have you participated in any paid market research in the past 6 months?

Yes Thank the respondent and terminate.

No Continue.

Q19. For study purposes, if you participate, the interview will be audio recorded. Are you okay with us audio recording your interview?

Yes Continue.

No Thank the respondent and terminate.

Q20. What is your sex?

Male

Female

Other

Q21. What is the last grade or year of school you completed? (Read list. Recruit a mix)

For youth record current grade ___________

Less than high school diploma.

High school graduate or GED

Some college or 2-year degree

College degree

Postgraduate degree

Q22. Are you Hispanic, Latino/a, or of Spanish origin?

No Continue.

Yes Continue.

Q23. What is your race? (Read list. Recruit a mix.)

White

Black or African American

American Indian or Alaska Native

Asian Indian

Chinese

Filipino

Japanese

Korean

Vietnamese

Other Asian

Native Hawaiian

Guamanian or Chamorro

Samoan

Other Pacific Islander

Q24. For > 18

Please stop me when I read the range that includes the total amount you earn per year before taxes (Recruit a mix).

Less than or equal to $ 35,000 per year

More than $35,000 and less than or equal to $70,000

More than $70,000

Q25. Finally, during the interview, you will be asked to review written materials and offer your opinions; therefore, I need to ask whether you have a medical or nonmedical condition that affects your ability to read and/or understand written materials in English?

1. Yes Thank the respondent and terminate.

2. No Continue.

Great! You qualify for our study. The interview will be held on [DATE] at [TIME] and will last no longer than 60 minutes. For your time and opinions, you will receive [ADULT: $40, YOUTH: $20 and PARENT: $20] at the end of the session.

Would you like to participate in the interview at [TIME] on [DATE]?

Yes Continue.

No Thank the respondent and terminate.

Adolescent Instructions: You will need to bring the permission form I will send you with your parent or guardian’s signature when you come to the interview. If you don’t have this permission form, you won’t be able to participate. I would also like to send you a confirmation letter and directions to the place where we will hold the interview. In order to do so, please verify your mailing address and phone number where you can be reached. We are asking for your contact information only for the purpose of sending you a reminder letter and giving you a call to remind you of the interview. We will destroy all contact information when we are finished with all the interviews.

We are only inviting a few people, so it is very important that you let us know as soon as possible if for some reason you are unable to attend. Please call [recruiter] at [telephone number] if this should happen. We look forward to seeing you on [date] at [time]. If you normally wear corrective lenses, contacts, or glasses to read please remember to have them with you during the interview.

Parent Information for Adolescents Scheduled to Participate:

Now, I would like to give your parent/guardian this information that I just gave you about the interview. I will not share your responses to the questions I asked you.

Instructions to the Parent/Guardian

Your child is eligible to participate in the interview and has been scheduled to participate on [DAY], [DATE] at [TIME]. Because your child is under 18, we must get written permission from you in order for him/her to participate. We will be sending you a permission form to review and sign if you consent to your child’s participation. If you will be accompanying your child to his/her session, please bring this completed for with you. If you are unable to accompany your child, he/she must bring the signed permission form with him/her in order to participate. If you will be accompanying your child, we request that you wait in the parent waiting area during their interview. You will not be able to enter the interview room with your child. Your child will be given $75 for his/her participation. For study purposes, the interviews will be audio recorded, and project team members may observe the discussion in person or by video stream. If your child normally wears glasses on contact lenses to read please remind them to bring them.

Adult Information:

Great! May I please have your mailing and/or e-mail address to send you a confirmation letter with directions? [Verify address and phone number.] We are asking for your contact information only for the purpose of sending you a reminder letter and giving you a call to remind you of the interview. We will destroy all contact information at the conclusion of the interview.

We are only inviting a few people, so it is very important that you notify us as soon as possible if for some reason you are unable to attend. Please call [recruiter] at [telephone number] if this should happen. We look forward to seeing you on [date] at [time]. If you normally wear corrective lenses, contacts, or glasses to read please remember to have them with you during the interview.

Paperwork Reduction Act Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The public reporting burden for this information collection has been estimated to average 10 minutes per response to complete the Screener (the time estimated to read, review, and complete). Send comments regarding this burden estimate or any other aspects of this information collection, including suggestions for reducing burden, to [email protected].

**NOTE** THIS PAGE MUST BE STORED SEPARATELY FROM THE SCREENER AND DATA. PLEASE DESTROY UPON COMPLETION.

NAME: ____________________________________________________________

ADDRESS: ________________________________________________________

CITY: _________________________________________________

ZIP CODE: _________________________________________________

E-MAIL_______________________________________________________

What is the best time to reach you? What is the best telephone number to reach you at that time?

BEST TIME TO BE REACHED: ________________________________________

BEST PHONE NUMBER: ________________________________________

Is there another time and number we can try if we miss you?

ALTERNATE TIME:

ALTERNATE PHONE NUMBER:

Thank you. That’s all the questions I have today. Please try to arrive at least 15 minutes before the starting time. If you have any questions or find that you are unable to attend, please call [facility’s phone number] as soon as possible. Thank you again for your time. We look forward to seeing you at [TIME] on [DATE].

Read if necessary:

If you have any questions about the study, you may contact Jennifer Alexander at RTI at (301) 770-8219. If you have concerns about how participants are being treated in the study, you may contact RTI’s Office of Research Protection toll-free at 1-866-214-2043.

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