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 Formative Research for the National Children’s Study

Formative research for the National Children’s Study (NCS) consists of studies of limited duration and size conducted to explore new methodologies that could improve Study design and process. Examples include how to be more effective in information collection, data storage, analytic methods and study operations.

The NCS launched a formative research initiative in the 2011. NCS collaborators already under contract submitted proposals for projects ranging from reducing burden on participants to more effective ways to manage biological and environmental samples. Many of these projects were completed and resulted in publications in scientific journals. Some projects are still underway with new ones planned.

The Formative Research initiative provided data in a cost effective manner to improve efficiency and effectiveness of NCS operations, and establish proof of concept for various NCS activities. For further information, view details from some exemplar projects in the following chart.

Projects Description
Completed Example Projects
Study of Iodine Levels in Pregnant Women Researchers measured iodine levels in urine and found that although levels in the U.S. population were in adequate range overall, almost 56 percent of National Health and Nutrition Examination Survey (NHANES) pregnant women and 45 percent of NCS pregnant women did not have enough iodine in their urine. The lowest levels were found in non-Hispanic black participants, which was also a group that had the lowest dairy product consumption. They also observed that iodine levels changed based on where people live, with inadequate iodine levels in more than half of pregnant women in three out of the seven NCS geographic locations.
Ulnar Measurement to Track Growth in Infants and Children

NCS and its research partners have demonstrated that measuring the ulna (one of the bones of the forearm) at its widest part is a good substitute for measuring the full height or length of newborns, infants, or young children. The method is quick, reliable, and reduces stress on participants.

Previous studies have shown that ulnar length in persons ages five to more than 65 is a reliable predictor of height. The NCS pilot study, which enrolled a diverse group of children, is the first to use the measurement as a substitute for traditional height/length measurements in children less than five years old.
Placenta Studies NCS scientists tested different methods for placenta collection and conducted a careful analysis of placenta collection procedures in the Vanguard Study.  This enabled them to understand the feasibility and costs of collecting placentas and the methods needed to ensure that samples are not compromised during collection, transport, and storage.  Preliminary studies by the NCS demonstrated that collection and analyses of placentas is feasible.  The researchers showed that they could measure levels of environmental chemicals in placental tissue and test placental tissue for genetic markers. They also developed advanced methods for measuring the size, shape, and blood vessel patterns of placentas and showed that stem cells (cells with unique ability to divide and differentiate – that is, produce more of themselves and develop into different cell types – some are used in transplantation treatment of certain diseases) can be recovered and grown from the material they collected.
Remote Air Quality Monitoring This project demonstrated the application of sensor technology to remotely monitor air pollutants in residences. Investigators developed and tested portable devices that were capable of measuring various air pollutants, including volatile organic compounds and particles. Experiments tested the feasibility to construct and deploy these devices, participant acceptance of devices in homes, sensor performance and stability to detect specific air pollutants, and determination of duration and frequency of sampling intervals to capture data about emission of air pollutants indoors. More research is needed to identify and characterize device responses in homes and attempt to associate responses with specific sources or household activities.
Alternative Approaches for Improving NCS Procedures for Household Listing and Managing Segments with Ill-Defined Boundaries In traditional survey research methods the development of an address frame within sampled SSUs required “listing” of all residential structures. This can be resource- and time-intensive as census blocks are often incompatible with natural or manmade boundaries, such as power lines, political boundaries, etc.). More recently, this practice has been replaced or supplemented by data available from the US Post Office (referred to as a Delivery Sequence File or DSF). However, the DSF listings have been found to have inaccuracies correlated with levels of urbanicity. Management of possible invisible boundaries is critical as one could easily introduce sampling error due to under or over coverage of households along unclear segment boundaries.

This project created and then subsequently validated address lists in selected NCS segments from two study Counties, using traditional and enhanced methods. We analyzed segments in Worcester County, MA and Marion County, WV, representing a continuum of urban and rural environments. The project included two new approaches to this issue: (1) Evaluating the effectiveness of the DSF in combination with other GIS data to improve the listing of dwelling units in sampled SSUs; and (2) Developing a standardized method of defining segment-mapping with desirable statistical properties to effectively handle invisible or ill-defined boundaries.
In-progress Example Projects
Stress Measures in Pregnant Women The NCS is conducting an intensive experiment to determine which tools yield the most accurate data.  These tools will provide data on the range of stressors that pregnant women experience, how stress changes their behavior, and what reduces their stress.  They will also tell us the total “dose” of stress the fetus is exposed to and the child’s early health outcomes.
Autism The NCS is conducting research to develop and test more efficient approaches for confirming Autism Spectrum Disorders (ASD) in children participating in research studies.  Existing diagnostic confirmation approaches for ASDs are long, require extensive training to administer, and are fairly burdensome, making them challenging to incorporate into large, multipurpose research studies like the NCS.

To test new approaches for confirming ASDs in children participating in the NCS and other similar studies, researchers at the AJ Drexel Autism Institute at Drexel University have brought together eight clinical centers with expertise in autism diagnosis.  At each clinical center new, more streamlined approaches are being used side by side with traditional diagnostic approaches and the performance of the new streamlined approaches will be compared to the standard approaches.   The work will help the NCS develop an efficient and accurate strategy for confirming ASDs in participating children.
Development of a Bayley Short Form The NCS is developing a short form of the widely-used Bayley Scales of Infant and Toddler Development®, Third Edition (Bayley-III®). The goal is to develop short versions of longer tests to provide the NCS with shortened, but effective measures.  These Bayley-III® short forms will serve as strong baseline measures of child neurodevelopment.
Parental Mental Health Research has shown that commonly found mental health problems in parents are likely to have an impact on children's mental and behavioral health problems. Further, pediatric behavioral and mental disorders account for one in every five office visits to pediatricians and carry enormous medical and societal costs.  Thus, the NCS has an interest in screening parents for mental health conditions, such as depression and anxiety.

The University of Massachusetts Medical School is leading the development of a short parental mental health questionnaire.  This questionnaire aims to be briefer and more comprehensive than existing mental health screeners and will be of immense value to the NCS.
Dietary Assessment This Study assessed the feasibility, burden, and data quality of collecting dietary data on preschoolers using the web based, non-proprietary, 24 hour recall tool developed by the National Cancer Institute and Westat.  The tool is the Automated Self-Administered 24 hour Dietary Recall (ASA24). Data collection sites included UCLA, John Hopkins University, University of Hawaii, and University of Miami. To be eligible infants had to be between 24 & 59 months, free of birth defects or major chronic health condition that could interfere with feeding, living with a mother who was English speaking and in an ethnicity targeted group at their study center. 
Child Health Disparities This substudy aims to validate measures needed for studying health disparities and selected biomarkers. Developing the best measures for studying health disparities is of particular interest to the NCS because studies have shown that health literacy, discrimination, parenting self-efficacy, health care (access, utilization, and quality) contribute to health disparities. Additionally, aspects of the social environment such as social isolation, lack of control and contingency and social support, violence, discrimination, challenging and changing social relationships, and restricted access to health care are thought to interact with biological processes.