Justification

Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback” (OMB Control Number: 0920-0919)

TITLE OF INFORMATION COLLECTION:

Testing Act Early Messages for “Learn the Signs. Act Early.”

PURPOSE:

The “Learn the Signs. Act Early.” (LTSAE) campaign aims to promote 1) awareness of healthy developmental milestones during early childhood, 2) the importance of tracking each child’s development, and 3) the importance of acting early if there are concerns. A series of focus groups focusing on the third aim of the campaign will be conducted with parents/guardians. Focus groups will explore what it means to parents/guardians to act early on a concern about development. We will also gather parents/guardians’ feedback on “act early” messages; that is, messages that encourage parents/guardians to take action and not wait if they have a concern about their child’s development. Focus group discussion about “act early” messages will also include parents/guardians’ opinions about message comprehension, message relevance, and barriers to understanding or following the messages.

Research has shown that parents/guardians can be reliable sources of information about their children’s development. Several studies have found that parents/guardians’ concerns about their children’s development are generally valid and predictive of developmental delays (Squires, Nickel, & Eisert, 1996; Glascoe, 1997; 2003). These studies suggest that efforts can and should be made to encourage parents/guardians to take action if they suspect that their child could be showing signs of a developmental delay.

Findings from this research will aid the “Learn the Signs. Act Early.” campaign team in refining its “act early” messages to be used on the campaign website and in its materials for parents/guardians.

DESCRIPTION OF RESPONDENTS:

The respondents will:

• Be considered low-income parents/guardians ages 18-55,

• Have a child age 5 or younger,

• Not have worked in the medical field or in a clinic, hospital or doctor’s office,

• Be English-literate (comfortable speaking and reading English),

• Not have a child with a previously diagnosed developmental delay or disability,

• Not work in special education or with children who have special needs, and

• Not have a combined annual household income of more than $50K/year.

A copy of the focus group screener can be found in Attachment A. A copy of the informed consent can be found in Attachment B.

Table 1 presents the focus group research design with parents/guardians. We will conduct a total of 4 focus groups in 2 states (Baltimore, Maryland (MD)/District of Columbia (DC)/Virginia (VA) metropolitan area and Atlanta, Georgia (GA) metropolitan area). A copy of the focus group guide can be found in Attachment C.

Table 1. Focus Group Research Design (n = 4 focus groups)

	MD/DC/ VA metropolitan area	Atlanta, Georgia	Total
Number of focus groups	2	2	4
Total participants	20	20	40

TYPE OF COLLECTION: (Check one)

[ ] Customer Comment Card/Complaint Form [ ] Customer Satisfaction Survey

[ ] Usability Testing (e.g., Website or Software [ ] Small Discussion Group

[X] Focus Group [ ] Other: ______________________

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary.

2. The collection is low-burden for respondents and low-cost for the Federal Government.

3. The collection is non-controversial and does not raise issues of concern to other federal agencies.

4. The results are not intended to be disseminated to the public.

5. Information gathered will not be used for the purpose of substantially informing influential policy decisions.

6. The collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the future.

Name:__Denise Levis ([email protected])__________________

To assist review, please provide answers to the following question:

Personally Identifiable Information:

1. Is personally identifiable information (PII) collected? [ ] Yes [X ] No

2. If Yes, is the information that will be collected included in records that are subject to the Privacy Act of 1974? [ ] Yes [ ] No

3. If Applicable, has a System or Records Notice been published? [ ] Yes [ ] No

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants? [X ] Yes [ ] No

It is proposed that respondents will be given $40 per hour (for a total of $80 per respondent for the 2 hour focus groups) as a token of appreciation for their interest, effort, transportation, and possible childcare costs. This amount is comparable to the level of reimbursement for the target audiences in similar CDC funded activities. Because our target audience has small children at home, the incentive for these focus groups will help defray the cost of transportation and potential child care needs by allowing them to participate in the focus group. In addition, the focus groups will be held in facilities that do not offer childcare services due to liability concerns. Thus, the incentive needs to be adequate to help the participants cover outside childcare costs if needed, as well as transportation costs associated with attending the groups

As shown by the literature referenced below, the payment of incentives can also provide significant advantages to the government in terms of direct cost savings and improved data quality.

There have been citations in the literature referencing the importance of monetary compensation for focus group participation. Krueger (1994) indicates that offering minimal levels of monetary compensation will help ensure that sufficient numbers of participants will attend thereby yielding useful results. Further, in a meta-analysis of 38 experiments and quasi-experiments, Church (1993) found that providing cash incentives for participation was far more effective than nonmonetary gifts in generating survey response, and prepaid monetary incentives yielded an average increase of 19.1 percentage points over comparison groups.  Finally, findings related to the importance of monetary incentives are corroborated in the National Adult Literacy Survey by Berlin (1992) and colleagues (OMB No. 1850-0654, exp. 8/31/1993), and the National Survey of Family Growth.

Offering a monetary incentive at the proposed level will help ensure that respondents honor their commitment of participating in the focus group. Lower incentives could actually result in higher recruiting costs due to the need to over recruit by higher percentages (Krueger & Casey, 2009). To avoid these risks, CDC requests OMB approval to remunerate participants at the rate of $80 per 2-hour focus group session.

BURDEN HOURS

Screening Participants for Focus Groups

We estimated that screening of potential focus group participants takes an average of 3 minutes across all respondents. We estimate that for each eligible participant, 4 will be terminated. The total estimated response burden for focus group recruitment is 10 hours. We derived these burden hours using the following calculations:

Each location (Maryland and Georgia) will have 2 focus groups, for a total of 4 focus groups. Therefore:

4 focus groups x 50 invited and rejected participants = 200 participants x 3 minutes = 600 minutes/60 minutes = 10 hours

Focus Group Participation

Focus group participants will be asked to arrive 15 minutes prior to the session to review and sign an informed consent form. Estimated response burden for the informed consent process for 40 focus group participants (assuming 10 attend each group) is 10 hours for four focus groups.

The focus groups sessions are designed to last 2 hours, for a total of 120 minutes per participant. Thus, the estimated response burden anticipated for 40 focus group participants (again, assuming all 10 participants attend each focus group) is 80 hours for 4 focus groups.

Each location (Maryland and Georgia) will have 2 focus groups, for a total of 4 focus groups. Therefore:

4 focus groups X 10 invited participants = 40 participants X 15 minutes = 600 minutes/60 minutes = 10 hours for the informed consent process for invited participants

4 focus groups X 10 invited participants = 40 participants x 120 minutes = 4,800 minutes/60 minutes = 80 hours for invited participants

Estimated burden hours for all 4 focus groups (recruitment + informed consent + focus group discussions) = 100 hours

Category of Respondent	No. of Respondents	Participation Time	Burden
Screening Participants for Focus Groups
Parent Focus Group Screener	200	3/60	10 hours
Participation in Focus Groups
Focus Group Informed Consent	40	15/60	10 hours
Parent Focus Group Guide	40	2	80 hours
Totals			100 hours

FEDERAL COST: The estimated annual cost to the Federal government is _$53,294__

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents

1. Do you have a customer list or something similar that defines the universe of potential respondents and do you have a sampling plan for selecting from this universe? [ ] Yes [X ] No

If the answer is yes, please provide a description of both below (or attach the sampling plan)? If the answer is no, please provide a description of how you plan to identify your potential group of respondents and how you will select them?

Recruitment of Participants

The Westat team will work to recruit 6 primary care clinics serving young children age 5 and younger (3 in Baltimore, Maryland and 3 in Atlanta, Georgia) to participate in this research project. The role of clinics will be to assist in the recruitment of parents/guardians for focus groups. We hope to translate our findings from the focus groups into improvements and refinements to the existing LTSAE campaign messages and materials. (The existing LTSAE campaign materials that will be tested through this project include a booklet, brochure, and checklist that can be found in Attachments D, E and F, respectively.) We have established partnerships with clinics through existing projects, and we hope to leverage those relationships for this project. See Attachment G for a copy of the project factsheet that we will use to recruit clinics to participate in the project.¹ The six clinics will be selected from a convenience sample of clinics located in in the metropolitan areas surrounding Atlanta, Georgia and Baltimore, Maryland. These locations were selected to provide geographic diversity (southeast and northeast) and because of their proximity to the Centers of Disease Control and Prevention (CDC) and Westat offices. Westat staff will need to make regular visits to selected clinics to conduct informational site visits, drop off promotional material, and possibly conduct the planned parent focus groups at clinics sites. Thus, proximity to Westat offices is important and will help preserve project resources.

Once the clinics are recruited, we will ask them to hang posters (see Attachment H) in their waiting rooms and leave handouts (see Attachment I) at the front desk to promote the parent focus groups. Interested parents/guardians will be instructed to contact Westat (via email or phone) to be screened and scheduled into a group. Clinic representatives will have enough information about the project to answer some basic questions and can refer to the project factsheet if needed.

Parents/guardians of children who receive services from 1 of the 6 clinics will serve as the sample universe for the parent focus groups. Parents/guardians from the 3 Maryland clinics will be scheduled into 1 of the 2 Maryland focus groups and parents/guardians from the 3 Georgia clinics will be scheduled into 1 of the 2 Georgia groups. Westat staff will be responsible for screening, scheduling, and sending reminders to parents/guardians for the focus groups. Maryland focus groups will be held at the focus group facility on the Westat campus or at a place convenient for clinic patients (i.e., a designated room or the waiting room at the clinic after clinic hours) and the Georgia groups will be held at the local focus group facility, Atlanta Outloud. Westat will subcontract with the facility to host the groups, but Westat will be responsible for all the screening, scheduling and reminders.

Westat staff will employ standard over-recruitment methods to ensure that at least 8 parents/guardians attend each of the 4 groups. A total of 10 parents/guardians will be recruited per group and we will aim to have a mix of education levels and races represented in each group. Westat will provide CDC with weekly recruitment updates including number of participants scheduled by group and certain demographics.

Selecting Participants: Screening criteria

Statistical methods will not be used to select participants for the parent focus groups.  Because study participants are being recruited from clinic settings, Health Insurance Portability and Accountability Act (HIPAA) restrictions do not allow health centers to release contact information for their patients without their consent.  Thus, we must allow study participants from those who receive services at 1 of the 6 clinics to opt into the study.  Therefore we will ask clinics to hang posters and position flyers near the front desk to recruit parents/guardians. In addition, we seek to gather feedback from parents/guardians ages 18-55 who have a child age 5 or younger, are English-literate, do not work in the medical field or in a clinic, hospital, or doctor’s office, do not have a child with a previously diagnosed developmental delay or disability, do not work in special education or with children who have special needs, and do not have a household annual income of more than $50K.  This represents a sub-segment of the larger clinic population from which study participants are being selected.  See Attachment A for a copy of the focus group screener.

The screener includes standard questions to collect demographic information as well as other screening items designed to assess focus group eligibility. For example, aspects such as the following will be addressed using tailored questions and precise definitions to be developed:

Parent/legal guardian of a child

• Inclusion: Parents/guardians (mothers or fathers) ages 18-55 who are the biological parent or legal guardian of a child age 5 or younger

• Exclusion: Grandparents, childcare providers, or anyone else who may be accompanying the child to his/her pediatric appointment on the specific day that the focus groups were being promoted, and is not a legal guardian of that child

• Age of child

  • Inclusion: Parents/guardians with a child age 5 or younger

  • Exclusion: Parents/guardians who do not have children age 5 or younger

• Age of parent/guardian

  • Inclusion: Parents/guardians age 18-55

  • Exclusion: Anyone younger than 18 or older than 55

• Language

  • Inclusion: Parents/guardians who can read and speak English

  • Exclusion: Parents/guardians who do not read or speak English

• Parent/guardian ever worked in medical field

  • Exclusion: Parents/guardians who currently work or have ever worked in the medical field (including nurse, physician, or PA)

• Parent/guardian work in clinic, hospital, or doctor’s office

  • Exclusion: Parents/guardians who work in a clinic, hospital, or doctor’s office

• Child with a developmental delay or disability

  • Exclusion: Parents/guardians who have a child with a diagnosed developmental delay or disability

• Parent/guardian work in special education

  • Exclusion: Parents/guardians who work in special education or with children who have special needs

• Race/ethnicity

  • Inclusion: Range of ethnicities across all groups

  • Exclusions: None

• Education

  • Inclusion: Range of education levels across all groups

  • Exclusion: None

• Income

  • Inclusion: Range of income under $50,000 annually

  • Exclusion: Parents/guardians who report an annually income of over $50,001

Administration of the Instrument

1. How will you collect the information? (Check all that apply)

[ ] Web-based or other forms of Social Media

[ ] Telephone

[X ] In-person

[ ] Mail

[ ] Other, Explain

2. Will interviewers or facilitators be used? [X ] Yes [ ] No

Please make sure that all instruments, instructions, and scripts are submitted with the request.

Instructions for completing Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback”

TITLE OF INFORMATION COLLECTION: Provide the name of the collection that is the subject of the request. (e.g. Comment card for soliciting feedback on xxxx)

PURPOSE: Provide a brief description of the purpose of this collection and how it will be used. If this is part of a larger study or effort, please include this in your explanation.

DESCRIPTION OF RESPONDENTS: Provide a brief description of the targeted group or groups for this collection of information. These groups must have experience with the program.

TYPE OF COLLECTION: Check one box. If you are requesting approval of other instruments under the generic, you must complete a form for each instrument.

CERTIFICATION: Please read the certification carefully. If you incorrectly certify, the collection will be returned as improperly submitted or it will be disapproved.

Personally Identifiable Information: Provide answers to the questions.

Gifts or Payments: If you answer yes to the question, please describe the incentive and provide a justification for the amount.

BURDEN HOURS:

Category of Respondents: Identify who you expect the respondents to be in terms of the following categories: (1) Individuals or Households;(2) Private Sector; (3) State, local, or tribal governments; or (4) Federal Government. Only one type of respondent can be selected.

No. of Respondents: Provide an estimate of the Number of respondents.

Participation Time: Provide an estimate of the amount of time required for a respondent to participate (e.g. fill out a survey or participate in a focus group)

Burden: Provide the Annual burden hours: Multiply the Number of responses and the participation time and divide by 60.

FEDERAL COST: Provide an estimate of the annual cost to the Federal government.

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents. Please provide a description of how you plan to identify your potential group of respondents and how you will select them. If the answer is yes, to the first question, you may provide the sampling plan in an attachment.

Administration of the Instrument: Identify how the information will be collected. More than one box may be checked. Indicate whether there will be interviewers (e.g. for surveys) or facilitators (e.g., for focus groups) used.

Please make sure that all instruments, instructions, and scripts are submitted with the request.

1 Task 2 data collection activities are covered under a separate OMB request.

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