SS Part B

SUPPORTING STATEMENT FOR THE

Parents’ Perceptions of Public Service Announcement Concepts

on Electronic Nicotine Delivery Systems

(OMB No. 0920-0910, Exp. Date 3/31/2018)

PART B: STATISTICAL METHODS

November 20, 2015

Submitted by:

Office on Smoking and Health

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

Department of Health and Human Services

Refer questions to:

Michelle O’Hegarty

Office on Smoking and Health

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

4770 Buford Highway, NE MS F-79

Atlanta, Georgia 30341

770-488-5582

FAX: 770-488-5939

E-mail: [email protected]

TABLE OF CONTENTS

B. STATISTICAL METHODS

1 Respondent Universe and Sampling Methods

2 Procedures for the Collection of Information 3 Methods to Maximize Response Rates and Deal with No response

4 Tests of Procedures or Methods to be Undertaken

5 Individuals Consulted on Statistical Aspects and Individuals Collecting and/or

Analyzing Data

LIST OF ATTACHMENTS

1. Screener

2. Informed Consent

3. ICF Institutional Review Board Approval

4. Moderator’s Guide

5. Educational material for distribution at the conclusion of each focus group: CDC’s Factsheet

“Electronic Nicotine Delivery Systems: Key Facts”

6. Confirmation Reminder Script

7. Educational material for distribution at the conclusion of each focus group: Smoker Cessation

Material Fact Sheet

Notes on Excluded Attachments

In this GenIC, the Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC) outlines a plan to test 3 draft concepts, as demonstrated through a storyboard, with content that may be considered sensitive. The draft materials are not included in the attachments for this GenIC because:

• Publically releasing the Public Service Announcement (PSA) concepts can contaminate the feedback from participants, compromising the ability to get unbiased information.

• The PSAs have not been approved for public distribution by HHS/Assistant Secretary for Public Affairs (ASPA).

• The untested PSAs could be perceived by the public as ineffective or offensive (testing is designed to identify potential problems).

• Release of the PSAs must be coordinated with the launch of the Surgeon General’s Call to Action on Electronic Nicotine Delivery Systems (ENDS) Among Youth and Youth Adults. The specific contents of the Surgeon General’s Call to Action on ENDS Among Youth and Young Adults is proprietary and release of the PSA concepts may compromise its development.

To support adequate review of this GenIC by OMB, CDC requests permission to provide OMB with a secure link to the draft materials.

Section B: Statistical Methods

B.1 Respondent Universe and Sampling Methods

This is a descriptive and exploratory qualitative data collection. Statistical methods will not be used to select respondents. The study design calls for a total of 9 focus groups with adults 30-60 years of age who are parents or guardians of children ages 12-17 years. Focus groups will be conducted in three cities: New Orleans, LA; Cleveland, OH; and Tulsa, OK. Cities were selected based on prevalence rates of adult and youth smokers by state, as well as ENDS use by region. The cities represent moderate to high conventional cigarette smoking prevalence and are cities are in the regions seeing highest growth in ENDS use among adults, the Midwest and South. The target audiences will be segmented by smoking and ENDS use status because conventional cigarette smokers only (No ENDS use), ENDS users and nonsmokers may have different beliefs and behaviors related to tobacco use, secondhand smoke, and secondhand aerosol exposure, and thus may respond differently to certain types of messages. Table 1 describes our recruitment strategy. Our aim is to include 10 respondents for each focus group for a total of 90 respondents. We anticipate that approximately 1 out of 2 people contacted will meet the eligibility criteria and agree to participate. Therefore, we anticipate that 20 people will be contacted and screened for each focus group in order to recruit 10 for participation. This suggests that approximately 180 people total (i.e., 9 focus groups x 20 people) will be contacted and screened using the screener (Attachment 1).

Table 1. Recruitment Strategy

Target Audience	New Orleans, LA	Cleveland, OH	Tulsa, OK	Total No. of Focus Groups
Cigarettes = No Ends = No	1	1	1	3
Cigarettes = Yes ENDS = No	1	1	1	3
Cigarettes = Yes or No, ENDS = Yes	1	1	1	3
Total	3	3	3	9

B.2 Procedures for the Collection of Information

The data collection contractor, ICF International (ICF), will be responsible for coordinating data collection activities with professional recruitment firms, collecting and summarizing information, and preparing reports. ICF will subcontract with professional recruitment firms for 9 focus groups. The professional recruitment firms will screen and recruit participants from their existing databases according to the screener (Attachment 1) and the segmentation strategy via telephone 2-3 weeks before the focus groups. Participants will be selected based on the following eligibility criteria:

Inclusion Criteria

• Adult participants will be at least 30 years of age, but not older than 60

• Adult participants will be parents or guardians of one or more children 12-17 years of age

• No more than one adult parent will be recruited from the same household

• Participants must be fluent in English

• Participants will include a mix of both middle and lower household incomes (59,999 or less per year) based on income statistics in each city

• Each focus group will include a balance of male and female participants

• All groups have the same recruitment requirements with the exception of race/ethnicity. Recruitment will attempt to mirror the race/ethnic mix in each city detailed below. For example, groups in New Orleans will be comprised of more Black or African American participants than groups in Tulsa.

  • The three selected cities are comprised of:

    • New Orleans: 33% White alone, 60.2% Black or African American, .3% American Indian or Alaska Native, 2.9% Asian, Z (Value greater than zero but less than half unit of measure shown) Native Hawaiian and Other Pacific Islander alone, 5.2% Hispanic/Latino, 1.7% Two or more races, 30.5% White (not Hispanic or Latino)

    • Cleveland: 37.3% White alone, 53.3% Black or African American alone, .3% American Indian and Alaska Native alone, 1.8% Asian alone, Z (Value greater than zero but less than half unit of measure shown) Native Hawaiian and Other Pacific Islander alone, 2.8% Two or More Races, 10% Hispanic or Latino, 33.4% White alone, not Hispanic or Latino

    • Tulsa: 62.6% White alone, 15.9% Black or African American alone, 5.3% American Indian and Alaska Native alone, 2.3% Asian alone, .1% Native Hawaiian and Other Pacific Islander alone, 5.9% Two or More Races, 14.1%, 57.9% White alone, not Hispanic or Latino

Exclusion Criteria

• Must not have participated in a focus group within the last six months

• Participants or anyone in their household must not have been an employee of an ad agency, market research firm, the CDC, or a company involved in the manufacture or retail sale of tobacco or electronic-cigarette products

The professional recruitment firms will recruit participants until the quotas are filled. The firms will then confirm participant availability 1 week before the focus group and remind participants of the date and time of their focus group via telephone 1 to 2 days beforehand (Attachment 6). The focus groups will be conducted in person at focus group facilities by a professionally trained ICF moderator. The focus group discussions will involve review of the three draft concepts. Participants will be asked a series of questions to determine their understanding of the concepts. They will be asked to assess attitudes and perceptions of the concepts for the PSAs about ENDS that will be released as part of the Surgeon General’s Call to Action on ENDS among Youth and Young Adults. Then, the participants will rank the one they think will best motivate them to communicate with youth and young adults in their lives about the potential dangers of using ENDS and exposure to ENDS aerosol. Each focus group will last approximately 1.5 hours. ICF staff will attend the focus groups to take notes on a laptop computer and coordinate logistics of checking in participants and obtaining informed consent (Attachment 2). All focus groups will be audio recorded and later transcribed verbatim without identifiers by a professional transcriptionist. Focus groups will be streamed to allow for CDC observation.

ICF will explain the study and ask participants to sign an informed consent form if they agree to participate prior to attending the focus group. ICF staff will explain the process and distribute and collect the consent forms. Before each group, the moderator will review the consent form with the participants to ensure that they understand their rights and to ensure they are participating voluntarily. The consent forms will be printed in duplicate, with one copy retained by ICF and the other copy provided to the project participants. The consent forms retained by ICF will be stored in a locked filing cabinet at ICF. Only select project staff will have access to the project files. At the end of the groups, ICF will provide each participant the CDC Factsheets “Electronic Nicotine Delivery Systems: Key Facts” (Attachment 5) and Smoker Cessation Material Fact Sheet (Attachment 7). Given the focus groups are sponsored by CDC, there may be requests for information about e-cigarettes. In addition, participants in our focus groups will include current smokers of conventional cigarettes, a known health harm. These fact sheets are educational resources that are consistent with CDC public health messaging around use of conventional cigarettes and cessation and information about e-cigarettes.

B.3 Methods to Maximize Response Rates and Deal with No Response

The recruitment plan includes a gift of $75 per participant for their travel time, childcare costs, and to convey appreciation for their contribution to this voluntary study. After the initial recruitment, a reminder telephone call is placed to each participant in order to maximize response rate. The call is made to each recruited respondent by the professional recruitment firms approximately 48 hours before the focus group date (Attachment 6).

B.4 Test of Procedures or Methods to be Undertaken

The proposed project involves the collection of qualitative information. Questions included in these focus groups were pilot-tested with a minimal number of individuals (< 9) matching the characteristics of the target audience via a convenience sample of ICF employees and their friends/family members. Several questions were eliminated from the guide in order to keep the session under 1.5 hours (Attachment 4). The ordering of questions was also changed and refined as a result of the pilot test.

B.5 Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

There are no statistical aspects of this project. This project utilizes qualitative methods. The person responsible for project design is Ronne Ostby. The people responsible for data collection are Ronne Ostby and Lindsay Dashefsky. The person responsible for data analysis is Hope Cummings.

ICF International 530 Gaither Road Rockville, MD 20850
Ronne Ostby	Project Director	Phone: 301.407.6594 E-mail:  [email protected]
Lindsay Dashefsky	Senior Research Associate	Phone: 301.572.0508 E-mail:  [email protected]
Hope Cummings	Senior Health Communications Researcher	Phone: 301.572.0508 Email: [email protected]

Individuals consulted at CDC on the study design are listed below.

Centers for Disease Control and Prevention Office on Smoking and Health 4770 Buford Highway, N.E MS F-79 Atlanta, GA 30341
Shanna Cox	Associate Director for Science	Phone: 770.488.6477 E-mail:  [email protected]
Diane Beistle	Chief, Health Communication Branch	Phone: 770.488.5066 E-mail:  [email protected]
Michelle O’Hegarty	Health Communication Specialist	Phone: 770.488.5582 E-mail:  [email protected]

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