Adolescent -Pretest

Experimental Study of Cigarette Warnings

Session 1 Survey

Adolescent -Pretest

OMB: 0910-0866

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OMB #0910-NEW

Expires XX/YY/20XX



SESSION 1 SURVEY INSTRUMENT


[DISPLAY THE STATEMENT BELOW ON A SINGLE PAGE]


[DISPLAY TEXT “OMB # 0910-NEW, expires XXXX” IN THE SAME PAGE]


Paperwork Reduction Act Statement: The public reporting burden for this information collection has been estimated to average 12 minutes per response to complete this survey (the time estimated to read and complete). Send comments regarding this burden estimate or any other aspects of this information collection, including suggestions for reducing burden, to PRAStaff@fda.hhs.gov.


SECTION A: HEALTH BELIEFS


First, we would like to ask you some questions about your beliefs about smoking-related health effects.


Please tell us how much you agree or disagree with the following statement:


[RANDOMIZE ORDER OF ITEM “BLOCKS” ACCORDING TO ITEM PREFIXES WITH NUMBERS (I.E. RANDOMIZE A1_, A2_, A3_ SERIES, ETC.). ALSO RANDOMIZE ORDER OF QUESTIONS WITHIN BLOCKS. DISPLAY AS SCROLLING LIST.

ALSO, RANDOMLY SELECT ACONT1_1, ACONT2_1, OR ACONT3_1 AND DISPLAY AFTER 4TH BLOCK. RANDOMLY SELECT AND DISPLAY ONE OF THE REMAINING TWO “ACONT_” ITEMS AFTER 8TH BLOCK. DISPLAY THE FINAL “ACONT_” ITEM AFTER 12TH BLOCK.]


[DO NOT DISPLAY: WARNING: Cigarettes are addictive]


A1_1. Cigarettes are addictive


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


[DO NOT DISPLAY: WARNING: Tobacco smoke can harm your children]


A2_1. Tobacco smoke can harm your children


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


[DO NOT DISPLAY: WARNING: Smoking can kill you]


A3_1. Smoking can kill you


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


[DO NOT DISPLAY: WARNING: Smoking causes fatal lung disease in nonsmokers]


A4_1. Smoking causes fatal lung disease in nonsmokers


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


[DO NOT DISPLAY: WARNING: Quitting smoking now greatly reduces serious risks to your health]


A5_1. Quitting smoking now greatly reduces serious risks to your health


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


[DO NOT DISPLAY: WARNING: Smoking causes head and neck cancer]


A6_1. Smoking causes head cancer


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


A6_2. Smoking causes neck cancer


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


[DO NOT DISPLAY: Smoking causes bladder cancer, which can lead to bloody urine]


A7_1. Smoking causes bladder cancer, which can lead to bloody urine


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


A7_2. Smoking causes bladder cancer


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer



[DO NOT DISPLAY: WARNING: Smoking during pregnancy stunts fetal growth]


A8_1. Smoking during pregnancy stunts fetal growth


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


[DO NOT DISPLAY: WARNING: Smoking can cause heart disease and strokes by clogging arteries]


A9_1. Smoking causes heart disease


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


A9_2. Smoking causes strokes


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


A9_3. Smoking clogs arteries


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


A9_4. Smoking clogs arteries, which causes heart disease


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


A9_5. Smoking clogs arteries, which causes strokes


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer

[DO NOT DISPLAY: WARNING: Smoking causes COPD, a lung disease that can be fatal]


A10_1. Smoking causes COPD, a lung disease that can be fatal


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


A10_2. Smoking causes COPD


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


A10_3. Smoking causes lung disease that can be fatal


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


[DO NOT DISPLAY: WARNING: Smoking reduces blood flow, which can cause erectile dysfunction]


A12_1. Smoking reduces blood flow, which can cause erectile dysfunction


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


A12_2. Smoking reduces blood flow


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


A12_3. Smoking can cause erectile dysfunction


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


[DO NOT DISPLAY: WARNING: Smoking reduces blood flow to the limbs, which can require amputation]


A13_1. Smoking reduces blood flow to the limbs, which can require amputation


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


A13_2. Smoking reduces blood flow to the limbs


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


A13_3. Smoking can lead to amputation


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


[DO NOT DISPLAY: WARNING: Smoking causes type 2 diabetes, which raises blood sugar]


A14_1. Smoking causes type 2 diabetes, which raises blood sugar


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


A14_2. Smoking causes type 2 diabetes


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer



[DO NOT DISPLAY: WARNING: Smoking causes age-related macular degeneration, which can lead to blindness]


A15_1. Smoking causes age-related macular degeneration, which can lead to blindness


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


A15_2. Smoking causes age-related macular degeneration


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


A15_3. Smoking can lead to blindness


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


[DO NOT DISPLAY: WARNING: Smoking causes cataracts, which can lead to blindness]


A16_1. Smoking causes cataracts, which can lead to blindness


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


A16_2. Smoking causes cataracts


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


[DO NOT DISPLAY: CONTROL STATEMENT – NO ASSOCIATED WARNING LABEL]


ACONT1_1. Smoking causes migraines


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


[DO NOT DISPLAY: CONTROL STATEMENT – NO ASSOCIATED WARNING LABEL]

ACONT2_1. Secondhand smoke causes sleep disorders like insomnia in children


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


[DO NOT DISPLAY: CONTROL STATEMENT – NO ASSOCIATED WARNING LABEL]


ACONT3_1. Smoking during pregnancy causes hearing loss in babies


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


SECTION B: STIMULI EXPOSURE + STIMULI-SPECIFIC ASSESSMENT


PROTOCOL


WITHIN EACH STUDY GROUP (ADULT SMOKER, ADULT NONSMOKER, YOUNG ADULT SMOKER, YOUNG ADULT NONSMOKER, YOUTH SMOKER, YOUTH SUSCEPTIBLE), RANDOMLY ASSIGN PARTICIPANTS INTO A CONTROL CONDITION (0) OR ONE OF 16 TREATMENT CONDITIONS USING LEAST FILL QUOTAS TO ACHIEVE THE APPROXIMATE DISTRIBUTIONS IN TABLE 1. GENERATE VARIABLE FOR STUDY CONDITION ASSIGNED.


TABLE 1. STUDY CONDITION ALLOCATION

Condition

Adult (25+) Current Smoker

Adult (25+) Non-smoker

Young Adult (18-24) Current Smoker

Young Adult (18-24) Non-smoker

Youth (13-17) Current Smoker

Youth (13-17) Susceptible to Smoking

TOTAL

0 (Control)

512

512

274

290

54

438

2,080

1

118

118

66

65

11

102

480

2

118

118

66

65

11

102

480

3

118

118

66

65

11

102

480

4

118

118

66

65

11

102

480

5

118

118

66

65

11

102

480

6

118

118

66

65

11

102

480

7

118

118

66

65

11

102

480

8

118

118

66

65

11

102

480

9

118

118

66

65

11

102

480

10

118

118

66

65

11

102

480

11

118

118

66

65

11

102

480

12

118

118

66

65

11

102

480

13

118

118

66

65

11

102

480

14

118

118

66

65

11

102

480

15

118

118

66

65

11

102

480

16

118

118

66

65

11

102

480

TOTAL

2,400

2,400

1,330

1,330

230

2,070

9,760


EACH RESPONDENT WILL BE EXPOSED TO CIGARETTE WARNING STUMULI ACCORDING TO THEIR STUDY CONDITION, AS SHOWN IN TABLE 2. EACH RESPONDENT WILL SEE THEIR ASSIGNED STIMULI IN 2 SEPARATE FORMATS (PACK AND AD) SEQUENTIALLY, IN RANDOM ORDER. GENERATE VARIABLE TO INDICATE WHICH OF THE 4 SG STIMULI (0_1, 0_2, 0_3, 0_4) RESPONDENTS IN THE CONTROL CONDITION WERE ASSIGNED.


TABLE 2. STIUMUL EXPOSURE BY STUDY CONDITION

Condition

Exposure

0 (Control)

Random selection (using least fill quotas to ensure approximately even distribution) of 1 of the following SG statements:


0_1: SURGEON GENERAL’S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, and May Complicate Pregnancy.

0_2: SURGEON GENERAL’S WARNING: Quitting Smoking Now Greatly Reduces Serious Risks to Your Health.


0_3: SURGEON GENERAL’S WARNING: Smoking by Pregnant Women May Result in Fetal Injury, Premature Birth, and Low Birth Weight.


0_4: SURGEON GENERAL’S WARNING: Cigarette Smoke Contains Carbon Monoxide.

1

WARNING: Cigarettes are addictive. [GHW]

2

WARNING: Tobacco smoke can harm your children. [GHW]

3

WARNING: Smoking can kill you. [GHW]

4

WARNING: Tobacco smoke causes fatal lung disease in nonsmokers. [GHW]

5

WARNING: Quitting smoking now greatly reduces serious risks to your health. [GHW]

6

WARNING: Smoking causes head and neck cancer. [GHW]

7

WARNING: Smoking causes bladder cancer, which can lead to bloody urine. [GHW]

8

WARNING: Smoking during pregnancy stunts fetal growth. [GHW]

9

WARNING: Smoking can cause heart disease and strokes by clogging arteries. [GHW]

10

WARNING: Smoking causes COPD, a lung disease that can be fatal. [GHW – IMAGE 1]

11

WARNING: Smoking causes COPD, a lung disease that can be fatal. [GHW – IMAGE 2]

12

WARNING: Smoking reduces blood flow, which can cause erectile dysfunction. [GHW]

13

WARNING: Smoking reduces blood flow to the limbs, which can require amputation. [GHW]

14

WARNING: Smoking causes type 2 diabetes, which raises blood sugar. [GHW]

15

WARNING: Smoking causes age-related macular degeneration, which can lead to blindness. [GHW]

16

WARNING: Smoking causes cataracts, which can lead to blindness. [GHW]


[DISPLAY THIS STATEMENT ONLY ON A SINGLE PAGE]


INTRO_TEXT_1. Next, we are going to ask you to view images of a cigarette pack and cigarette advertisement. Please view each image carefully and answer the questions that follow to the best of your ability.


[NEXT PAGE]


[RANDOMIZE ORDER OF PACK AND AD STIMULI. SHOW SINGLE STIMULI (PACK OR AD) AND CORRESPONDING INTRO TEXT ON A SINGLE SCREEN. FORCE MINIMUM OF 5 SECOND EXPOSURE. THEN, SHOW REMAINING STIMULI AND CORRESPONDING INTRO TEXT ON A FOLLOWING SCREEN. FORCE 5 SECOND EXPOSURE. RECORD LENGTH OF TIME ON EACH EXPOSURE PAGE]


PACK_INTRO. Please take a moment to look at the cigarette pack below. Note that you can scroll to zoom in and drag to rotate the image.


This 3D image may take up to 30 seconds to load . . . please be patient.


[SHOW PACK STIMULI]


AD_INTRO. Please take a moment to look at the cigarette advertisement below. Note that you can scroll to zoom in.


[SHOW AD STIMULI]


[KEEP 2ND AD STIMULI VISIBLE ON SCREEN FOR EACH QUESTION IN SECTION B. AUTOMATICALLY ADVANCE AFTER PARTICIPANT SELECTS A RESPONSE IN SECTION B.]


B1_INTRO. Now we are going to ask you some questions about the warning you just saw.



B1. Before today, had you heard about the specific smoking-related health effect described in the warning?


1. Yes

2. No

3. I’m not sure


B2_INTRO. Please tell us how much you agree or disagree with the following statements.


B2. This warning grabbed my attention.


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


B3. This warning helps me understand the negative health effects of smoking


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer


B4. I would notice this health warning if I saw it.


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer



B6. I would read or look closely at this health warning if I saw it on cigarette packages or ads


1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

9. Prefer not to answer



B8. This warning is…


B8_1. Not at all informative [1]

[2]

[3]

[4]

[5]

[6]

Very informative [7]

Prefer not to answer [9]

B8_2. Hard to understand

[2]

[3]

[4]

[5]

[6]

Easy to understand [7]

Prefer not to answer [9]



B9_INTRO. Next, we would like to know whether you think this warning is an opinion or a fact. Opinions are judgments or feelings that cannot be proven true or false. Facts are statements that can be proven true or false.


B9. Would you say that this warning is an opinion or a fact?


1. Opinion

2. Fact

9. Prefer not to answer


B10. How much does this warning make you think about the health risks of smoking?


1. Not at all

2. A little

3. Somewhat

4. A lot

9. Prefer not to answer


B12. To what extent did you learn something new from this warning that you did not know before?


Not at all [1]

[2]

[3]

[4]

[5]

[6]

Very much [7]

Prefer not to answer [9]



SECTION C: DEMOGRAPHICS


C1_INTRO. Now we are going to ask you a few questions that are not about cigarettes or smoking.


[ASK IF SA1 ≥ 18]

C1. Thinking about members of your family living in this household, what is your combined annual income, meaning the total pre-tax income from all sources earned in the past year?


1. $0 to $9,999

2. $10,000 to $14,999

3. $15,000 to $19,999

4. $20,000 to $34,999

5. $35,000 to $49,999

6. $50,000 to $74,999

7. $75,000 to $99,999

8. $100,000 or more


C2. How many adults (age 18 or older) and children (aged 17 or younger), including yourself, live in your household?


C2_1. Adults (age 18 or older):__________[DROP-DOWN MENU, RANGE 1-20]

C2_2. Children (age 17 or younger):__________[DROP-DOWN MENU, RANGE 0-20 (FORCE RESPONSE OF 1-20 FOR YOUTH RESPONDENTS)]


C3. Please indicate your state of residence.


[INSERT DROP DOWN MENU WITH STATES]


[ASK IF SA1 ≥ 18]

C4. Do you think of yourself as…


1. Heterosexual or straight

2. Homosexual, or gay or lesbian

3. Bisexual

4. Something else (Other)










[ASK IF SA1 ≥ 18]

C5. Please answer the following question based on the information in the text above.


If a person is at high risk for heart disease, which of the following levels of low density lipoprotein (LDL) cholesterol is best?


1. 102

2. 86

3. 129

4. 155

5. Not sure


ENDSCREEN: You’ve reached the end of the survey. Thank you for your participation. As a reminder, you will be invited to participate in two more surveys as part of this study. As a thanks for your participation, [IF AGE >= 18: “you”; IF AGE < 18 “your parent”] will 1,000 Lifepoints for each survey that you take. Please keep an eye out for an invitation to the next survey in the next day or two.


[DISPLAY THE STATEMENT BELOW ON THE END SCREEN IN SMALLER FONT]


Paperwork Reduction Act Statement: The public reporting burden for this information collection has been estimated to average 12 minutes per response to complete this survey (the time estimated to read and complete). Send comments regarding this burden estimate or any other aspects of this information collection, including suggestions for reducing burden, to PRAStaff@fda.hhs.gov.








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