2014-09768. Proposed Data Collections Submitted for Public Comment and Recommendations

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-7570 or send comments to LeRoy Richardson, at 1600 Clifton Road, MS D74, Atlanta, GA 30333 or send an email to [e-mail].

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice.

Proposed Project

Reaching Underserved Populations through Learn the Signs. Act Early. Materials—New—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Learn the Signs. Act Early. (LTSAE) campaign, developed by the Centers for Disease Control and Prevention, is designed to increase awareness of developmental milestones among parents, healthcare professionals, childcare providers and others who regularly interact with young children. Increased awareness is expected to lead to increased developmental screening, the first in a series of steps toward early intervention which is essential for the health and well-being of children with developmental delays.

Developmental delays are increasingly common among all young children, with recent national estimates ranging from 13-15%. However, children from minority and low-income groups are particularly vulnerable due to lags in identification. Not only do healthcare and early childhood professionals frequently fail to identify children with developmental disabilities, but parents also need to be educated about child development, especially parents living in poverty who are less likely to recognize a child's special needs. Because early identification of developmental delays is critical to positive outcomes, young children from minority and low-income groups may miss a critical window of opportunity if developmental concerns are not identified in a timely way.

The purpose of this study is to understand how the LTSAE campaign is meeting the needs of underserved families when delivered as part of the Women, Infant and Children (WIC) nutrition program. By understanding how LTSAE materials and messages affect awareness and behavior of WIC participants and staff, the CDC can determine what improvements may be needed in order to effectively reach this at-risk population. The three phases of the study will measure changes in parents' awareness, knowledge and intention to act, and WIC staff responses to the LTSAE materials and messages. This information will help guide the CDC in developing the messages, materials, partnerships and strategies that are most effective for families served by WIC.

The data collection system consists of four questionnaires and a structured focus group. These form the basis of three phases of the study designed to determine the effectiveness of LTSAE materials and messages with WIC participants and staff.

In Phase 1, pre- and post-implementation parent-report surveys will determine the LTSAE campaign's impact on parental awareness, knowledge and intention to act if there is a developmental concern. These will be paper surveys administered during routine WIC clinic visits. The parent survey was pilot tested by three parents receiving WIC services and reviewed by 14 WIC staff. The Pre-intervention Survey will be completed by 450 respondents, who are parents/guardians of children enrolled in the WIC Nutrition Program at nine WIC clinics in four counties in the St. Louis, Missouri area. The Post-intervention Survey will be completed by the same 450 parents/guardians of children enrolled in the WIC Nutrition Program who completed the Pre-intervention Survey.

In Phase 2, a referral outcome tracking form will be completed by 100 parents/guardians of children enrolled in the WIC Nutrition Program and will document whether the study protocols will impact the behavior of parents of children with possible delays. If a developmental delay is suspected, WIC staff will give the parent a referral to the child's doctor and encourage the parent to talk with the doctor about the child's development. WIC staff will complete a referral outcome tracking form during the parent's subsequent visits to the WIC clinic to determine whether the parent followed up with the doctor, how the doctor responded to the parent's concerns and whether the child accessed screening, diagnostic and treatment services. We estimate each parent will return to the clinic twice during the study for activities such as WIC eligibility re-certification. This offers the opportunity to track referral outcomes over time. The Referral Outcome Tracking Form will be completed twice by the same 100 parent/guardian respondents.

In Phase 3, two measures will evaluate the WIC staff's response to the study to help determine program and message improvements, feasibility and sustainability. An online survey will assess staff perceptions of factors such as key elements, such as ease of use, time requirements and perceived impact on children and families. The WIC Developmental Milestones Staff Survey will be completed by 47 WIC staff members who work in the WIC clinics in the 9 sites where the project will be implemented. Each staff member also will be sent an email invitation to attend one 60-minute focus group meeting. This will allow for further clarification of the group's response. WIC staff members have provided feedback to refine questions, ensure accurate programming and establish the estimated time required to complete this data collection process.

The estimate for burden hours is based on the number of questions included in the questionnaires, as well as survey pre-testing to determine the typical length of time for completion. To obtain maximum potential burden estimates, we did not factor in attrition during the course of the study but rather assumed that all participants would complete all measures.

The total estimated burden is 255 hours. There is no cost to respondents other than their time.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden hours
Parents/guardians of children receiving WIC enrolled in Phase 1	Pre-Intervention Survey	450	1	10/60	75
	Post-Intervention Survey	450	1	10/60	75
Parents/guardians of children enrolled in Phase 2	Referral Outcome Tracking Form	100	2	15/60	50
WIC staff enrolled in Phase 3	WIC Developmental Milestones Staff Survey	47	1	10/60	8
WIC staff enrolled in Phase 3	Focus Group Questions	47	1	1	47
Total					255

LeRoy Richardson,

Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.