OMB Change request

0910-0753 OMB Change request Memo 11.1.17.docx

Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaign

OMB Change request

OMB: 0910-0753

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Evaluation of the Public Education Campaign on Teen Tobacco (OMB Control No. 0910-0753)


Change Request (83-C)

November 1, 2017


The Food and Drug Administration is submitting this nonmaterial/non-substantive change request (83-C) to incorporate edits to the study documents for two information collections under this control number: the Rural Smokeless Tobacco Education Campaign evaluation (RuSTEC) and the Evaluation of the Public Education Campaign on Teen Tobacco (ExPECTT). These information collections evaluate both The Real Cost and The Real Cost Smokeless. RuSTEC is a longitudinal control/intervention study in rural areas and has completed 3 rounds of data collection (baseline and 2 follow ups) to date. ExPECTT is a longitudinal nationally representative study which has completed 5 rounds of data collection (baseline and 4 follow ups) with its first cohort, and is now in preparations to recruit a second cohort for the next phase of the evaluation. OMB has concurred with the submission of this change request.


The purpose of this change request is to:

  • Update the documents for the third follow up round of data collection for RuSTEC

  • Request an increase in burden for RuSTEC Follow up 3

  • Add an additional wave of data collection (fourth follow up) to RuSTEC

  • Update the documents for the first round of data collection for the second cohort of ExPECTT


RuSTEC Follow up 3

Follow up 3 is planned for January 2018. Due to high retention rates, we are requesting an additional 146 annualized burden hours to complete Follow up 3.

OMB Attachment #

Change

Rationale

1. SS Part A

Update burden and add 4th follow-up

Additional burden needed because of large response rate and additional follow-up because of delayed campaign launch

2. SS Part B

Update number of expected completes add 4th follow-up

Text edits to include adjusted completes and fourth follow-up

2_R. Youth Follow up 3 Instrument

Revise programming /administrative text throughout

Edit for clarity and FU3 data collection

Update example photos of tobacco products

Change example photos to include current tobacco products

Add items to measure awareness of smokeless tobacco use consequences

New advertisements are targeting different health consequences of smokeless tobacco use

Remove items that are not needed or useful

Items removed either because the campaign does not cover the topic, they are ceilinged, do not reflect current use patterns, or are not useful

Add influencer question

Item added to determine how influential celebrities affect behavior

Add media items and delete media items not use

Add and delete media items to collect data on current advertising

6_R1. Parent Permission

Minor text edits

Edit text for clarity and new round of data collection

6_R2. Youth Assent

Minor text edits

Edit text for clarity and new round of data collection

10_R. Lead Letter

Minor text edits

Edit for clarity and new round of data collection

11_R. Questions and Answers

Minor text edits

Edit for clarity and new round of data collection

Add RTI logo

Add logo to identify study to longitudinal participants

14_R. Notifications

Minor text edits

Edit for clarity and new round of data collection

16_R. Panel_Maint_Update_Form

Add request for permission to use text messages

Texting participants to set up interview appointments has improved response rates in other studies

18_R. Survey Invitation Email

Minor text edits

Edit for clarity

19_R. Email_reminder1

Minor text edits

Edit for clarity and new round of data collection

20_R. Email_reminder2

Minor text edits

Edit for clarity and new round of data collection

21_R. Email_reminder3

Remove references to early bird incentive

Email will be sent after early bird expires

Minor text edits

Edit for clarity and new round of data collection

22_R. Panel Maintenance Email

Minor text edits

Edit for clarity and new round of data collection

Add request for permission to use text messages

Texting participants to set up interview appointments has improved response rates in other studies

26_R. Questions and Answers about the Evaluation – 18


Minor text edits

Edit for clarity and new round of data collection

29_R. Email reminder 1 – 18

Minor text edits

Edit for clarity and new round of data collection

30_R. Email reminder 2 – 18

Minor text edits

Edit for clarity and new round of data collection

31_R. Email reminder 3 – 18

Minor text edits

Edit for clarity and new round of data collection

32_R. Panel Maintenance Letter - 18

Minor text edits

Edit for clarity and new round of data collection

33_R. Panel Maintenance Update Form – 18

Add request for permission to use text messages

Texting participants to set up interview appointments has improved response rates in other studies

35_R. Panel Maintenance Email – 18

Minor text edits

Edit for clarity and new round of data collection

Add request for permission to use text messages

Texting participants to set up interview appointments has improved response rates in other studies

36_R. Post_Card_Reminder_Notice

New form

Post card to remind participants to complete the survey in an effort to maintain high level of response rates

37_R. Text Message for non-responders

New form

Text for Field Interviewers to use to send text messages to non-responding participants in an effort to maintain high level of response rates



RuSTEC Follow up 4

We also seek approval to add a fourth follow-up to the RuSTEC study due to a problem encountered by the media buying company at the start of the campaign, which reduced the level of advertising that occurred during that time. To make up for this lapse in potential exposure of the target audience to the campaign, an additional round of data collection is needed. We request an additional 359 annualized burden hours to complete this additional round of data collection.

OMB Attachment #

Change

Rationale

2_R. Youth Follow up 4 Instrument

Update programming and skip patterns

Update for fourth follow up



ExPECTT Cohort 2, First Wave

Documents for the ExPECTT survey were updated in the extension of the overarching control number approved 09/13/16. The next round of data collection is planned for May 2018.

Document Name

Change

Source Document, Source Approval Date

2_E2a. Youth Baseline Instrument

Edits to advertisements, KABs and tobacco.

Based on Attachment 2_E2a. Approved 9/13/16

3_E2a. Screener Tablet Parent Guardian

Added language about a quality control system.

Added a question about: household race, internet access, SNAP. Deleted questions: e-cig use. Changed: Call the Field Director to Call the ExPECTT project assistance line and added the words: toll free number.

Based on Attachment 3_E2a. Approved 9/13/16

3_E2b1. Screener Mail Parent Guardian A

Reduced and reworded original question, added 3 questions to encourage response. Reformatted for clarity.

Based on Attachment 3_E2b. Approved 9/13/16

3_E2b2. Screener Mail Parent Guardian B

Same as Screener A except for the additional questions. Reformatted for clarity.

Based on Attachment 3_E2b. Approved 9/13/16

3_E2c. Parent/Guardian Instrument

Changes on media questions. Added some questions on current tobacco use status and household tobacco use. Added some language for clarity.

Based on Attachment 2_E2c. Approved 9/13/16

3_E2d. Screener Reminder Letter

New Document

New document

3_E2e. Screener Reminder Postcard

New Document

New document

6_E2b1. Permission Parent Baseline

Added information about sample size, information about the selection of youth, clarity about interaction with interviewer, about privacy and future contact.

Based on Attachment 6_E2b. Approved 9/13/16

6_E2b2. Permission Parent Follow-up

Edited information regarding when the contact is taking place, incentive, future contacts and early bird dates.

Based on Attachment 6_E2b. Approved 9/13/16

6_E2c. Assent Youth

Updated info on sample size, time of survey, incentive, toll free number and information about calling the call line.

Based on Attachment 6_E2c. Approved 9/13/16

6_E2d. Consent Youth 18+ 3rd Follow-up

Updated info on sample size, time of survey, incentive, toll free number and information about calling the call line.

Based on Attachment 6_E2d. Approved 9/13/16

6_E2e. Parent Guardian Consent

Added language about a quality control system, toll free number and information about calling the call line and a question to agree.

Based on Attachment 6. Approved 10/13

8_E2. Study Description

Updated research study contact information for participants.

Based on Attachment 8_E2. Approved 9/13/16

9. Privacy and Data Security

Slight editing changes. Added descriptions on USERID, privacy info on the CARI privacy control statement,

Based on Attachment 9. Approved 9/13/16

10_E2a. Lead Letter Baseline

Update approved lead letter to for newly recruited participants.

Based on Attachment 10_E2. Approved 9/13/16

10_E2b. Lead Letter 1st and 2nd Follow-up

Update approved lead letter for follow ups for first and second follow up waves

Based on Attachment 10_E1. Approved 9/13/16

10_E2c. Lead Letter 3rd Follow-up

Update approved lead letter for third and final wave of data collection

Based on Attachment 10_E1. Approved 9/13/16

11_E2. Q & A’s about the ExPECTT Evaluation

Updated research study contact information for participants.

Based on Attachment 11_E2. Approved 9/13/16

12_E2. Telephone Verification Survey

Programing language added in for clarity.

Attachment 12_E2. Telephone Verification Survey. Approved 9/13/16

18_E2a. Survey Invitation Email 1st and 2nd Follow-up


Updated research study contact information for participants. Added in Fill in Field for Early Bird Date.

Based on Attachment 19_E1. Approved 9/13/16

18_E2b. Survey Invitation Email 3rd Follow-up

Updated research study contact information for participants. Added in Fill in Field for Early Bird Date.

Based on Attachment 18_E1. Approved 9/13/16

19_E2a. Email Reminder 1 1st and 2nd Follow-up

Updated research study contact information for participants.

Based on Attachment 19_E1. Approved 9/13/16

19_E2b. Email Reminder 1 3rd Follow-up

Updated research study contact information for participants.

Based on Attachment 19_E1. Approved 9/13/16

20_E2a. Email Reminder 2 1st and 2nd Follow-up

Updated research study contact information for participants.

Based on Attachment 20_E1. Approved 9/13/16

20_E2b. Email Reminder 2 3rd Follow-up

Updated research study contact information for participants.

Based on Attachment 20_E1. Approved 9/13/16

21_E2a. Email Reminder 3 1st and 2nd Follow-up

Updated research study contact information for participants. Updated wording for current wave of data collection.

Based on Attachment 21_E1. Approved 9/13/16

21_E2b. Email Reminder 3 3rd Follow-up

Updated research study contact information for participants. Updated wording for current wave of data collection.

Based on Attachment 21_E1. Approved 9/13/16


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