Formative Research to Revise Materials for Mothers and Child Care Providers of Infants (Individuals and Households)

Generic Clearance to Conduct Formative Research

Attachment A- Consent Package for Mothers Revised 031518

Formative Research to Revise Materials for Mothers and Child Care Providers of Infants (Individuals and Households)

OMB: 0584-0524

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OMB Control # 0584-0524

Expiration Date: 9/30/2019

Attachment A –Consent Package for Mothers and Expectant Mothers: Focus Group Flyer, Consent Cover Letter, Informed Consent Form, Questionnaire for Participation, and Focus Group Reminder Phone Call Script


OMB Burden Statement: According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0584-0524. The time required to complete this information collection is estimated to average 2 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.


Focus Group Flyer


We’re looking for mothers of babies 18 months or younger and expectant mothers to join a 60-minute group conversation with other mothers and expectant mothers about feeding infants.


Participating mothers and expectant mothers will receive a free meal, if the focus group is held during a meal time, and $40 for their participation.

Shape1 Shape2

There are 5 ways to sign up:

Visit [link to online screener]

Text “Mother” to [research team cell number]

Call 646-801-4261

Email Gerad O’Shea at [email protected]

Complete the attached consent form and return it to [child care provider’s name]

Focus Group Details

Location

[site name and address]


Date

[insert focus group date(s)]


Time

[insert focus group times]







Feel free to share this opportunity with family and friends!




OMB Burden Statement: According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0584-0524. The time required to complete this information collection is estimated to average 4 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.


Consent Cover Letter

[Date]


Dear Potential Research Participant,


You are invited to participate in a focus group discussion with other mothers or expectant mothers as part of the research titled Formative Research to Revise Materials for Mothers and Child Care Providers of Infants. The United States Department of Agriculture (USDA) Food and Nutrition Service (FNS) is developing a guide for feeding infants in child care settings and materials to support breastfeeding. Applied Curiosity Research (ACR) will be gathering feedback from child care providers, directors, mothers, and expectant mothers to ensure these materials are clear, relevant, and engaging.


Participating in this research is an exciting opportunity for you to share your opinion on free draft materials so that they will be suitable for mothers and expectant mothers like yourself. Included in this packet you will find information on the research and your rights as a research participant, a consent form, and a brief questionnaire.


We look forward to working with you!


Sincerely,

Gerad O’Shea

Research Director, Applied Curiosity Research



OMB Burden Statement: According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0584-0524. The time required to complete this information collection is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.


Mother/Expectant Mother Informed Consent Form

Study Title

Formative Research to Revise Materials for Mothers and Child Care Providers of Infants

Protocol Number

XXX

Principal Investigator

Gerad O’Shea

Contact Information

Phone: 646-801-4261

Email: [email protected]


Background & Purpose: You are invited to participate in a research study conducted by ACR as part of a USDA FNS sponsored effort to develop a guide for feeding infants in child care settings and materials to support breastfeeding. We are working to ensure the revised materials are clear, relevant, and engaging for child care providers and new and expectant mothers.


Process: As part of the research, you will participate in a 60-minute focus group discussion with other mothers or expectant mothers. During the focus group, you will be asked to discuss your attitudes, beliefs, and thoughts around feeding babies. You will also be asked to review the materials to provide feedback on the extent to which they are relevant, clear, and engaging. A total of about 128 mothers and expectant mothers will be selected across the country.


Possible Risks & Benefits: We do not anticipate any risks associated with being in this study. You will receive a $40 stipend to cover the cost of travel and child care. We also anticipate that most people will enjoy participating in the research process, which will lead to the development of free resources developed by the USDA.


Compensation: You will receive a $40 stipend.


Participant’s Rights: Participation in this study is voluntary. We will not work with you unless you give your consent. You have the right to change your mind and withdraw your consent or discontinue participation at any time without any penalty or loss of the benefits to which you are otherwise entitled. You have the right to refuse to answer particular questions. Your name, address, and phone number will only be used to contact you about this research. They will not be given to anyone else for other purposes. The research may be audiotaped for research purposes only. Your name will never be used in any reports of our research findings. Your information will be kept secure and only used for research purposes, except as otherwise required by law. All data will be identified only by an ID number assigned by the research team, not by any name.


Contact Information: If you have any questions, concerns, or complaints about this research study, its procedures, risks, and benefits, please contact the Principal Investigator, at the telephone number listed on the first page of this form.


If you have any questions or complaints about your rights as a research subject, contact:


Mail

Study Subject Adviser

Chesapeake Research Review, Inc.

7063 Columbia Gateway Drive, Suite 110

Columbia, MD 21046

Call collect

410-884-2900

Email

[email protected]









Please complete the sections below if you agree to participate. A copy of this form will be emailed to you for your records.


I, _____________________________________, agree to participate in a 60-

(print name)

minute focus group interview. I understand that if I participate in this focus group that none of my information will be shared outside of this research.



______________________________ _________________

Signature Date



____________________________________________

Phone


____________________________________________

Email Address


We will only contact you about the time and place of the focus group. What is the best way to reach you? (Select all that apply)

( ) Call

( ) Text

( ) Email


Please provide your contact information below. We will only contact you about this research.


Cell phone number: _____________

Email address: ________________________


Privacy Statement:

Purpose: Information is collected primarily for use by Applied Curiosity Research on behalf of the Food and Nutrition Service of the Supplemental Nutrition Assistance Program.

Authority: Federal statutes requiring studies of the food assistance programs: 7 U.S.C. 2011-27; 42 U.S.C. 1751-89; 7 U.S.C. 1431, 1431e, 612c, 612c note which is in the System of Record Notice in the Federal Registrar.

Routine Use: Information will only be used to contact you regarding the focus group interview. Please see System of Record Notice FNS-8, FNS Studies and Reports, published in the Federal Register on 4/25/1991 at 56 FR 19078


Disclosure: Furnishing the information on this form is voluntary, but failure to provide any contact information will result in withdrawal from participation in the focus group interview.  

OMB Burden Statement: According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0584-0524. The time required to complete this information collection is estimated to average 4 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.


Questionnaire for Participation in Research

Please choose the option that best answers each question for you.

  1. Are you a parent?

( ) No, I am not a parent.

( ) No, but I am currently pregnant.

( ) Yes, I am a mother.

( ) Yes, I am a father or other relative.

  1. If you are a mother, have you breastfed your child in the past 18 months?

( ) Yes,

( ) No

  1. How old are your child(ren)? Select all that apply.

( ) Younger than 2 years ( ) 6-8 years old

( ) 2-3 years old ( ) 10-12 years old

( ) 4-5 years old ( ) Older than 12 years

  1. What is your ethnicity?

( ) Hispanic or Latino ( ) Not Hispanic or Latino

  1. What is your race (select one or more)

( ) American Indian or Alaskan Native

( ) Asian

( ) Black or African American

( ) Native Hawaiian or Other Pacific Islander

( ) White



  1. What is your current age?

( ) Under 18 ( ) 35-44

( ) 19-24 ( ) 45-54

( ) 25-34 ( ) 55+

  1. What is the total number of people that live in your household?

( ) 1 ( ) 5 ( ) Other: please specify____________

( ) 2 ( ) 6

( ) 3 ( ) 7

( ) 4 ( ) 8

  1. What is the approximate total income everybody in your household, including yourself, will earn this year?

( ) $22,310 or less ( ) $53,243 - $60,975

( ) $22,311 - $30,043 ( ) $60,976 – 68,708

( ) $30,044 - $37,776 ( ) $68,709 - $76,442

( ) $37,777 - $45,509 ( ) $76,443 or more

( ) $45,510 - $53,242


OMB Burden Statement: According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0584-0524. The time required to complete this information collection is estimated to average 4 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.


Focus Group Reminder Phone Call Script


Hello, is [name] available?


Hi, [name], this is _________ from Applied Curiosity. I’m calling to follow up about the group interview about feeding infants that you signed up for.


The interview will be held on [date/time range] at [location]. As a reminder, you will receive $40 for your participation as well as a free meal [for groups held during meal time].


Can you confirm that you will be able to attend? Will you be bringing your children?


Thank you and we look forward to seeing you on [date]!



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